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Category: COVID-19 News

COVID-19 Top News – July 6, 2020

July 6, 2020

Sylvant (siltuximab) / BeiGene, Jazz
EUSA Pharma Announces FDA Approval of Phase 3 Clinical Trial for Siltuximab in Hospitalized Patients With COVID-19 Associated Acute Respiratory Distress Syndrome (Businesswire) – Jul 2, 2020 – “EUSA Pharma…today announced that the U.S. Food & Drug Administration (FDA) has approved a randomized, double-blind, placebo-controlled Phase 3 clinical trial protocol to evaluate the safety and efficacy of intravenous siltuximab plus standard of care in hospitalized patients with COVID-19 associated Acute Respiratory Distress Syndrome (ARDS)….The multicentre trial will aim to enrol approximately 400 patients with viral ARDS and elevated serum levels of IL-6.”

 

Sarconeos (BIO101) / Biophytis
Biophytis Receives FDA IND Clearance for COVA, a Phase 2/3 Clinical Trial with Sarconeos (BIO101) for the Treatment of Patients with COVID-19 Related Respiratory Failure (GlobeNewswire) – Jul 2, 2020 – “Biophytis SA…today announces that the United States (US) Food and Drug Administration (FDA) has accepted the Investigational New Drug (IND) application to proceed with its clinical development program COVA. This Phase 2/3 program will assess Sarconeos (BIO101) as a potential treatment for acute respiratory failure associated with COVID-19….’We have already initiated the work to start this key Phase 2/3 trial as soon as possible in the US, and in the European countries where we received approval, and will update the market shortly on our planned timelines.'”

 

BNT162b1 / Fosun Pharma, BioNTech, Pfizer
Pfizer and BioNTech Announce Early Positive Data from an Ongoing Phase 1/2 Study of mRNA-based Vaccine Candidate Against SARS-CoV-2 (GlobeNewswire) – Jul 1, 2020 – P1/2, N=7,600; NCT04368728; Sponsor: Biontech SE; “Further data from the ongoing Phase 1/2 clinical trial of four vaccine candidates will enable selection of a lead candidate and dose level for a large, global Phase 2b/3 safety and efficacy study that may begin as early as July 2020….Companies are expecting to manufacture up to 100 million doses by the end of 2020 and potentially more than 1.2 billion doses by the end of 2021; Pfizer Inc. (NYSE: PFE) and BioNTech SE…today announced preliminary U.S. data from the most advanced of four investigational vaccine candidates from their BNT162 mRNA-based vaccine program….Preliminary data demonstrated that BNT162b1 could be administered in a dose that was well tolerated and generated dose dependent immunogenicity.”

 

remdesivir / Generic mfg.
Gilead’s $2,340 Price for Coronavirus Drug Remdesivir Draws Criticism (The Times) – Jun 29, 2020 – “…it will charge $2,340 for a typical treatment course for people covered by government health programs in the United States and other developed countries. Gilead Sciences announced the price Monday for remdesivir, and said the price would be $3,120 for patients with private insurance….The treatment courses that the company has donated to the U.S. and other countries will run out in about a week, and the prices will apply to the drug after that…In 127 poor or middle-income countries, Gilead is allowing generic makers to supply the drug; two countries are doing that for around $600 per treatment course….The Institute for Clinical and Economic Review…said remdesivir would be cost-effective in a range of $4,580 to $5,080 if it saved lives.”

 

Kevzara (sarilumab) / Asahi Kasei, Regeneron, Sanofi
Regeneron and Sanofi Provide Update on Kevzara (sarilumab) Phase 3 U.S. Trial in COVID-19 Patients (PRNewswire) – Jul 2, 2020 – P2/3, N=2,500; NCT04315298; Sponsor: Sanofi; “Regeneron Pharmaceuticals, Inc…and Sanofi today announced that the U.S. Phase 3 trial of Kevzara® (sarilumab) 400 mg in COVID-19 patients requiring mechanical ventilation did not meet its primary and key secondary endpoints….Based on the results, the U.S.-based trial has been stopped….A separate Sanofi-led trial outside of the U.S. in hospitalized patients with severe and critical COVID-19 using a different dosing regimen is ongoing. The same Independent Data Monitoring Committee (IDMC) is overseeing both the Regeneron-led U.S. trial and the Sanofi-led trial outside of U.S. and has recommended that the trial outside of the U.S. continue. The companies expect to report results of the trial outside of the U.S. in Q3 2020.”

 

INO-4800 / Inovio, The Wistar Institute
INOVIO Announces Positive Interim Phase 1 Data For INO-4800 Vaccine for COVID-19 (Inovio Press Release) – Jun 30, 2020 – P1, N=120; NCT04336410; Sponsor: Inovio Pharmaceuticals; “INOVIO…today announced positive interim clinical data of INO-4800…from the first two Phase 1 clinical trial cohorts….INO-4800 has been selected to participate in a non-human primate (NHP) challenge study as part of the U.S. government’s Operation Warp Speed, a new national program aiming to provide substantial quantities of safe, effective vaccine for Americans by January 2021….INOVIO has expanded its Phase 1 trial to add older participants in additional cohorts and plans to initiate a Phase 2/3 efficacy trial….An independent Data Safety Monitoring Board reviewed the safety data. INO-4800 was generally safe and well-tolerated in all participants in both cohorts through week 8; all ten reported adverse events (AEs) were grade 1 in severity, and most were local injection site redness. There were no reported serious adverse events (SAEs).”

 

Coronavirus Vaccine / Sinopharm; BBIBP-CorV / Wuhan Institute of Virology, Sinopharm
Covid-19 vaccine candidate shows promising results in human trials, says Chinese firm (The Hindu Business Line) – Jun 28, 2020 – P1/2, N=1,120; “China National Biotec Group (CNBG) said on Sunday that early human trials of its second Covid-19 vaccine candidate has shown promising results suggesting that it could be safe and effective….The two shots developed by CNBG had previously been tested with 2,000 volunteers in phase I and II trials conducted in China. One of the vaccines had been declared safe while the data for the second shot was expected to be released on June 28….The experimental vaccine candidate developed by the Chinese firm has induced high-level antibodies in participants in a Phase 1/2 clinical trial involving 1,120 healthy volunteers…”

 

BRIEF-U.S. FDA To Issue Guidance On Covid-19 Vaccine Approval – WSJ (Reuters) – Jun 30, 2020 – “U.S. FDA TO ISSUE GUIDANCE ON COVID-19 VACCINE APPROVAL ON TUESDAY – WSJ; U.S. FDA’S CONDITIONS FOR APPROVING COVID-19 VACCINE INCLUDE REQUIREMENT THAT ANY VACCINE BE AT LEAST 50% MORE EFFECTIVE THAN A PLACEBO.”

 

remdesivir / Generic mfg.
European Commission Grants Conditional Marketing Authorization for Gilead’s Veklury (remdesivir) for the Treatment of COVID-19 (Businesswire) – Jul 3, 2020 – “Gilead Sciences, Inc….today announced that the European Commission has granted conditional marketing authorization for Veklury® (remdesivir) as a treatment for SARS-CoV-2 infection….The conditional marketing authorization was granted in the interest of public health due to the COVID-19 pandemic and was based on a rolling review of supporting data that began in April 2020. Under this authorization, Veklury is indicated for the treatment of COVID-19 in adults and adolescents (aged 12 years and older and weighing at least 40 kg), with pneumonia requiring supplemental oxygen. ‘We appreciate the European Medicines Agency’s rapid review of remdesivir in recognition of the unprecedented nature of this pandemic,’ said Merdad Parsey, MD, PhD…”

 

The coronavirus may have mutated to become more infectious, Dr. Anthony Fauci says (cnbc) – Jul 2, 2020 – “Research is underway to confirm the possible mutation and its implications, Fauci said, adding that ‘there’s a little dispute about it.’ Viruses naturally mutate and scientists have previously said they have observed minor mutations in the coronavirus that have not impacted its ability to spread or cause disease in any significant way.”

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COVID-19 Top News – June 29, 2020

June 29, 2020

stannous protoporphyrin (RBT-9) / Renibus Therap
Renibus Therapeutics Receives FDA Fast Track Designation for RBT-9 Treatment in COVID-19 (GlobeNewswire) – Jun 23, 2020 – “Renibus Therapeutics, Inc….announced today that it has been granted Fast Track designation by the FDA for RBT-9 treatment in COVID-19….RBT-9 has demonstrated antiviral activity in several enveloped viruses and inhibits a key mediator of viral replication in coronaviruses, including SARS-CoV-2 – the virus that causes COVID-19.”

 

losmapimod (FTX-1821) / Fulcrum Therap
Fulcrum Therapeutics Announces Initiation of Multi-Center Phase 3 (LOSVID) Trial with Losmapimod for Hospitalized COVID-19 Patients (GlobeNewswire) – Jun 24, 2020 – “Fulcrum Therapeutics, Inc….today announced that it received early notification from the U.S. Food and Drug Administration (FDA) that the company may proceed with initiating a Phase 3, randomized, double-blind, placebo-controlled trial of losmapimod…..LOSVID trial is…in approximately 400 patients hospitalized with COVID-19 and at risk of progression to critical illness….An interim analysis will be conducted in the fourth quarter of 2020 for futility and sample size re-estimation….Topline data is expected to be reported in the first quarter of 2021.”

 

hydroxychloroquine / Generic mfg.
It’s the end of road for hydroxychloroquine in COVID-19 as Novartis, NIH and WHO pull out of trials (Fierce Pharma) – Jun 22, 2020 – P=NA, N=470; “…the World Health Organization (WHO), generic hydroxychloroquine (HCQ) maker Novartis and the U.S. National Institutes of Health (NIH) have all ended their HCQ COVID-19 studies….Sanofi previously put a temporary halt to its own study based on safety….Novartis said it would discontinue its sponsored HCQ trial for COVID-19….NIH also decided that its Orchid study of HCQ would no longer continue after a fourth interim analysis by an independent data monitoring panel found the drug provided no additional benefit over placebo control.”

 

EDP1815 / Evelo Biosci
Evelo Biosciences Announces EDP1815 to Advance into Phase 2/3 TACTIC-E COVID-19 Trial (GlobeNewswire) – Jun 22, 2020 – “Evelo Biosciences, Inc….announced today that EDP1815 will be included in the TACTIC-E clinical trial. The trial will evaluate the safety and efficacy of certain experimental therapies….Interim data from the trial are anticipated during the fourth quarter of 2020. If the Phase 2/3 data are positive, Evelo plans to engage in discussions with global regulatory agencies to determine if the data support registration.”

 

aviptadil intravenous (RLF-100) / Relief Therap, NeuroRx
NeuroRx and Relief Therapeutics Announce Fast Track Designation Granted by the FDA to RLF-100 (Aviptadil) for the Treatment of Respiratory Distress in COVID-19 (GlobeNewswire) – Jun 24, 2020 – “NeuroRx, Inc….today announced that the U.S. Food and Drug Administration (FDA) awarded Fast Track Designation to NeuroRx for the investigation of RLF-100 (Aviptadil) for the treatment of acute lung injury/acute respiratory distress syndrome associated with COVID-19….As part of NeuroRx’s enrollment in the Fast Track program, the FDA has requested NeuroRx to submit a publicly-available expanded access policy…”

 

EMD Serono Initiates First Clinical Trial of TLR7 and 8 Inhibitor as a Potential Treatment for Severe Symptoms of Covid-19 Infection (EMD Serono Press Release) – Jun 25, 2020 – “EMD Serono…today announced the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug application (IND) for M5049 for the treatment of patients with Covid-19 pneumonia. The Company will initiate a Phase II randomized, controlled clinical study evaluating the safety and efficacy of M5049 in this patient population….M5049 will be investigated in a randomized, placebo-controlled study at sites in the United States and Brazil….In addition to the FDA, Merck KGaA, Darmstadt, Germany is working with other global health authorities and investigators to accelerate clinical development to meet the critical need presented by the current global pandemic and expects results from the Phase II study around the end of 2020.”

 

Celltex-AdMSCs / Celltex
Celltex Therapeutics Receives Another FDA Approval: Phase II Clinical Trial Using Mesenchymal Stem Cells (MSCs) as a Prophylactic Against COVID-19 (Businesswire) – Jun 26, 2020 – “Celltex…today announced that it has received approval from the U.S. Food and Drug Administration (FDA) to proceed with the Company’s Investigational New Drug application (IND 22055) to investigate the Prophylactic Efficacy of Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs) Against Coronavirus Disease 2019 (COVID-19).”

 

VP01 / Vicore Pharma
Battling the cytokine storm (PharmaTimes) – Jun 25, 2020 – “Researchers have recently identified part of the cytokine storm known as a ‘burning point’….The research shows that this occurs five days before what the authors describe as a ‘composite end point event’ or CEPE….Another marker identified by researchers is a deficiency of vitamin D….At Vicore we have been researching the RAS for nearly 20 years….We are trialling VP01, (sic) an experimental first in class low molecular weight angiotensin II receptor type 2 (AT2R) agonist, as a potential COVID-19 treatment.”

 

remdesivir / Generic mfg.
Gilead to Test Inhaled Form of Remdesivir in COVID-19 Starting in August (BioSpace) – Jun 22, 2020 – “‘From the onset of the pandemic, Gilead has advanced the development of our investigational antiviral remdesivir for the treatment of COVID-19, in parallel with emerging knowledge about the disease,’ said Merdad Parsey…’While the novel coronavirus appears to disproportionally affect adults-especially the elderly and those with underlying health conditions-concerning reports have been documented of children and young adults being hospitalized with COVID-19 and related autoimmune symptoms.'”

 

Hopeful for a COVID-19 vaccine by late 2020, early 2021: Dr Anthony Fauci (Financialexpress) – Jun 23, 2020 – “The government’s top infectious disease expert said Tuesday he is cautiously optimistic that there will be a COVID-19 vaccine by the end of the year or early 2021, but warned that the next few weeks will be critical to tamping down coronavirus hot spots around the country….’We will be doing more testing,’ Fauci told a House committee.”

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COVID-19 Top News – June 22, 2020

June 22, 2020

hydroxychloroquine / Generic mfg.
MHRA suspends recruitment to COVID-19 hydroxychloroquine trials (GOV.UK) – Jun 16, 2020 – “The Medicines and Healthcare products Regulatory Agency (MHRA) has instructed UK clinical trialists using hydroxychloroquine to treat or prevent coronavirus (COVID-19) to suspend recruitment of further participants….We followed the emerging concerns about use of hydroxychloroquine in COVID-19, and took into consideration the results from two different trials, including the UK’s RECOVERY trial which has provided convincing evidence of no meaningful mortality benefit in hospitalised patients with COVID-19.”

 

Actemra IV (tocilizumab) / Roche, JW Pharma
Roche rheumatoid arthritis drug fails to help COVID-19 patients in Italian study (Reuters) – Jun 18, 2020 – P2, N=398; NCT04346355; “Roche’s rheumatoid arthritis drug Actemra failed to help patients with early-stage COVID-19 pneumonia in an Italian study….It is pressing ahead with testing Actemra in another trial against COVID-19….The trial, which enrolled 126 patients, about a third of the intended number, was stopped early after an interim analysis raised doubts about the anti-inflammatory medicine’s effectiveness….Meanwhile, Roche has completed enrolment of its own Actemra study in patients hospitalized with severe COVID-19 pneumonia. That ‘will provide robust evidence about the benefit/ risk profile’, a Roche spokesman said, with data expected in the next few months.”

 

remdesivir / Generic mfg.
Favipiravir and Remdesivir get approval for treatment (The Economic Times) – Jun 20, 2020 – “In a seperate development, Maharashtra’s health minister Rajesh Tope said that Cipla and Hetero have received emergency marketing approval for Remdesivir for the treatment of severe Covid-19 patients from the drug controller of India…”

 

Aclaris Therapeutics Supports Investigator-Initiated Clinical Trial of ATI-450 for Cytokine Release Syndrome in Hospitalized Patients with COVID-19 (GlobeNewswire) – Jun 17, 2020 – “Aclaris Therapeutics, Inc….today announced that the FDA has allowed an investigational new drug application to evaluate ATI-450…in hospitalized patients with COVID-19. Aclaris is supporting an investigator-initiated trial of ATI-450 for cytokine release syndrome (CRS) in 36 hospitalized patients with COVID-19, and will provide funding and clinical drug supply to the University of Kansas Medical Center (KUMC), the sponsor of the trial….The trial is a Phase 2a, randomized, double-blind, placebo-controlled trial…”

 

mavrilimumab (KPL-301) / Kiniksa
Kiniksa Announces Lancet Rheumatology Publication of Clinical Outcomes with Mavrilimumab in COVID-19 (GlobeNewswire) – Jun 17, 2020 – P=Obs, N=1000; COVID-BioB (NCT04318366); “Kiniksa Pharmaceuticals, Ltd….today announced that clinical outcomes data from the open-label treatment protocol with mavrilimumab, an investigational fully-human monoclonal antibody that targets granulocyte macrophage colony stimulating factor receptor alpha (GM-CSFRα)…The 28-day clinical outcomes data from the open-label treatment protocol with mavrilimumab are described…”

 

MetaBlok (lsalt peptide) / Arch Biopartners
FDA Grants Arch Biopartners Permission to Proceed with Phase II trial to Evaluate Metablok (LSALT peptide) for the Treatment of COVID-19 patients (GlobeNewswire) – Jun 16, 2020 – “Arch Biopartners Inc….today announced that the U.S. Food and Drug Administration (FDA) has granted permission to the Company to proceed with a Phase II trial in the U.S. for its lead drug Metablok….The Company expects to begin the Phase II trial before the end of the summer, 2020.”

 

IFX-1 / Staidson Biopharma, InflaRx
InflaRx Reports Encouraging Topline Results from the Exploratory Phase II Part of the Adaptive Randomized Phase II/III Trial of IFX-1 in COVID-19 (GlobeNewswire) – Jun 17, 2020 – P2/3, N=30; “InflaRx…announced today interim results from the first 30 patients treated in the adaptive randomized Phase II/III trial….Relative change in the oxygenation index at day 5 showed no differences between treatment groups. However, IFX-1 treatment was associated with a lower 28-day all-cause mortality when compared to the best supportive care group….InflaRx is now evaluating continuing the study in an adequately powered, placebo-controlled, double blinded, Phase III part…”

 

Decadron (dexamethasone) / Merck (MSD)
The world will soon get coronavirus vaccine, health expert Anthony Fauci hopeful (Livemint) – Jun 19, 2020 – “On the treatment front, Fauci said he was ‘very impressed’ with results from a British trial into the steroid dexamethasone, which was found to reduce deaths among COVID-19 patients on ventilators by a third. However, given it works by suppressing the abnormal immune response that damages the body’s organs, rather than attacking the virus, Fauci cautioned it should not be prescribed too soon after a person was infected.”

 

dexamethasone / Generic mfg.
WHO welcomes preliminary results about dexamethasone use in treating critically ill COVID-19 patients (World Health Organization) – Jun 16, 2020 – “‘This is the first treatment to be shown to reduce mortality in patients with COVID-19 requiring oxygen or ventilator support,’ said Dr Tedros Adhanom Ghebreyesus…’This is great news and I congratulate the Government of the UK, the University of Oxford, and the many hospitals and patients in the UK who have contributed to this lifesaving scientific breakthrough.'”

 

remdesivir / Generic mfg.
Gilead to assess remdesivir in paediatric Covid-19 patients (Clinical Trials Arena) – Jun 18, 2020 – “The trial is expected to be completed in December this year….Merdad Parsey said in a statement: ‘From the onset of the pandemic, Gilead has advanced the development of our investigational antiviral remdesivir for the treatment of Covid-19, in parallel with emerging knowledge about the disease. ‘While the novel coronavirus appears to disproportionally affect adults, especially the elderly and those with underlying health conditions, concerning reports have been documented of children and young adults being hospitalised with Covid-19 and related autoimmune symptoms.'”

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COVID-19 | Status of Scientific Conferences 2020

June 22, 2020

Over 400 healthcare and pharma conferences have changed or cancelled their upcoming meetings because of COVID-19.  We have compiled an updated list on the current status of these conferences.

 

Click Here for Full Access

 

Last Updated: June 22, 2020

 

 

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COVID-19 Top News – June 15, 2020

June 15, 2020

mRNA-1273 / Moderna
Moderna advances late-stage development of its vaccine (mRNA-1273) against Covid-19 (Businesswire) – Jun 11, 2020 – “Moderna has finalized the Phase 3 study protocol based on feedback from the U.S. Food and Drug Administration (FDA). The randomized, 1:1 placebo-controlled trial is expected to include approximately 30,000 participants enrolled in the U.S….The Company expects dosing in the Phase 3 study to begin in July….The first cohort of healthy adults ages 18-54 years (n=300) in the Phase 2 study of mRNA-1273 is fully enrolled….Funding from the Biomedical Advanced Research and Development Authority (BARDA)…partially supported the planning for the Phase 2 and Phase 3 studies of mRNA-1273…”

 

mavrilimumab (KPL-301) / Kiniksa
Kiniksa announces 28-day clinical outcomes data from mavrilimumab treatment protocol in severe Covid-19 pneumonia and active U.S. IND for phase 2/3 clinical trial (GlobeNewswire) – Jun 8, 2020 – P=NA, N=39; “The company also announced an active investigational new drug application…for its global placebo-controlled Phase 2/3 clinical trial….Investigator-initiated placebo-controlled study in the U.S. is enrolling patients….28-day clinical outcomes data from the open-label treatment protocol….Death occurred in 0% (n=0/13) of mavrilimumab-treated patients by Day 28….Representative mavrilimumab-treated patients showed significant improvement in lung opacification on computerized tomography (CT) scans, consistent with the overall improvement in their clinical status.”

 

Yeliva (opaganib) / RedHill
Redhill Biopharma submits Covid-19 Clinical Trial Application for phase 2/3 study with opaganib (GlobeNewswire) – Jun 10, 2020 – “RedHill Biopharma Ltd….today announced that it has submitted a Clinical Trial Application (CTA) with the Ministry of Health of the Russian Federation for a Phase 2/3 clinical study evaluating opaganib (Yeliva®, ABC294640)….The multi-center, randomized, double-blind, parallel-arm, placebo-controlled Phase 2/3 study is planned to enroll 270 subjects with severe COVID-19 pneumonia requiring hospitalization and treatment with supplemental oxygenation.”

 

REGN10933/REGN10987 / Regeneron
Regeneron begins first clinical trials of anti-viral antibody cocktail REGN-COV2 for the treatment and prevention of Covid-19 (PipelineReview) – Jun 11, 2020 – “Regeneron Pharmaceuticals, Inc….announced initiation of the first clinical trial of REGN-COV2….The REGN-COV2 clinical program will consist of four separate study populations….The placebo-controlled trials will be conducted at multiple sites….The first two adaptive Phase 1/2/3 studies are evaluating REGN-COV2 (REGN10933+REGN10987) as a treatment for hospitalized and non-hospitalized patients with COVID-19. The Phase 1 portion will focus on virologic and safety endpoints, and the Phase 2 portion will focus on virologic and clinical endpoints.”

 

Vyrologix (leronlimab) / CytoDyn, Vyera Pharma
CytoDyn receives BLA acknowledgment letter from the FDA (GlobeNewswire) – Jun 8, 2020 – “CytoDyn Inc….announced today the U.S. Food and Drug Administration (FDA) advised the Company, subject to its ongoing review, it could receive its ‘PDUFA date’ on July 10, 2020.”

 

anti-SARS-CoV-2 hyperimmune globulin therapy / Grifols
Grifols starts production of its hyperimmune immunoglobulin as a potential passive immune therapy against Covid-19 (PRNewswire) – Jun 11, 2020 – “Grifols…today announced the start of production of its anti-SARS-CoV-2 hyperimmune immunoglobulin….The first doses are expected to be available in July 2020 as part of a clinical trial….Grifols is moving forward with its clinical trial in Spain to assess the effectiveness of high-dose intravenous immunoglobulin….Trial aims to assess the action of neutralizing antibodies…as well as determine the immunomodulatory potential…”

 

AZD1222 / Oxford Biomedica, Emergent Biosolutions, Jenner Institute, Vaccitech, AstraZeneca, University of Oxford
AstraZeneca to supply Europe with up to 400 million doses of Oxford University’s vaccine at no profit (AstraZeneca Press Release) – Jun 13, 2020 – “AstraZeneca has reached an agreement with Europe’s Inclusive Vaccines Alliance (IVA), spearheaded by Germany, France, Italy and the Netherlands, to supply up to 400 million doses of the University of Oxford’s COVID-19 vaccine, with deliveries starting by the end of 2020. With today’s agreement, the IVA aims to accelerate the supply of the vaccine and to make it available to other European countries that wish to participate in the initiative. The IVA is committed to providing equitable access to all participating countries across Europe.”

 

PiCoVacc / Sinovac
Sinovac announces positive preliminary results of phase I/II clinical trials for inactivated vaccine candidate against Covid-19 (Businesswire) – Jun 13, 2020 – P1/2, N=743; “Sinovac Biotech Ltd….today announced positive preliminary results of phase I/II clinical trial for the Company’s COVID-19 vaccine candidate, named CoronaVac, which showed favorable immunogenicity and safety profiles….There have been no severe adverse event reported in either the phase I or phase II trials….Vaccine induces neutralizing antibodies 14 days after the vaccination with a 0,14 day schedule. The Company expects to submit…phase III clinical study protocol to China’s National Medical Products Administration…”

 

Johnson & Johnson announces acceleration of its Covid-19 vaccine candidate; Phase 1/2a clinical trial to begin in second half of July (PRNewswire) – Jun 10, 2020 – “Johnson & Johnson…has accelerated the initiation of the Phase 1/2a first-in-human clinical trial of its investigational SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant….Phase 1/2a study will evaluate…Ad26.COV2-S, recombinant in 1045 healthy adults aged 18 to 55 years, as well as adults aged 65 years and older. The study will take place in the U.S. and Belgium. The Company is in discussions…to start the Phase 3 SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant, clinical trial ahead of its original schedule….The Company committed to the goal of supplying more than one billion doses globally through the course of 2021, provided the vaccine is a safe and effective.”

 

US To Fund And Conduct Key Studies On Three Possible COVID-19 Vaccines: Dr Anthony Fauci – Jun 11, 2020 – “‘The coronavirus vaccine effort is progressing very well and we expect more than one candidate vaccine to be in advanced clinical testing by early summer,’ Fauci…Fauci said the funding decision came from the Department of Health and Human Services, in consultation with the National Institutes of Health and other agencies.”

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COVID-19 Top News – June 8, 2020

June 8, 2020

ifenprodil (NP-120) / Algernon Pharma
Algernon receives U.S. FDA clearance for multinational phase 2b/3 human study to evaluate ifenprodil as a potential therapeutic for Covid-19 (GlobeNewswire) – Jun 4, 2020 – “Algernon Pharmaceuticals Inc….announce that it has received, on June 3rd, 2020, clearance from the U.S. FDA for its recently submitted Investigational New Drug (IND) application for its planned multinational Phase 2b/3 study of its re-purposed drug NP-120….’We have already begun the background work to start the Phase 2 trial in the U.S. and other countries as soon as possible and we will update the market shortly on our planned timelines.'”

 

 

TJM2 / I-Mab
I-MAB advances repositioned RA drug in early trial to treat Covid-19 cytokine storm (FierceBiotech) – Jun 1, 2020 – “Studies of COVID-19 patients have documented high levels of both GM-CSF and IL-6 in the bloodstream of those who become severely ill….I-MAB’s executives said during the call that if the results of part two of the TJM2 study in COVID-19 are positive, it will consult with the FDA to develop a plan to speed the drug to market. The company is also accelerating a manufacturing plan to ensure it will have enough of the drug for further clinical trials…”

 

 

AdCOVID (COVID-19 vaccine) / Altimmune, University of Alabama
Altimmune Launches Clinical Trial of T-COVID, an Investigational Intranasal Immune Modulator for the Treatment of Patients with Early COVID-19 (GlobeNewswire, Altimmune, Inc.) – Jun 1, 2020 – “Clearance of IND application received from the U.S. FDA; Planned Phase 1/2 outpatient clinical trial will focus on patients with early SARS-CoV-2 infection; Placebo-controlled trial expected to commence in June with data readout expected in Q4 2020; Therapeutic development program will complement Company’s single-dose intranasal COVID-19 vaccine candidate, AdCOVID; The planned clinical trial will evaluate the potential of T-COVID to prevent clinical worsening in patients with early COVID-19.”

 

 

astegolimab (RG 6149) / Amgen, Roche
BARDA, Genentech to accelerate phase 2 clinical trial for two investigational Covid-19 treatments (Homeland Preparedness News) – Jun 3, 2020 – “A partnership between the Biomedical Advanced Research and Development Authority (BARDA) and biotechnology company Genentech will yield a phase 2 clinical trial to evaluate two investigational drugs for the treatment of severe COVID-19 cases: anti-ST2 and IL-22-Fc. The drugs will be tested on approximately 300 patients with severe COVID-19 pneumonia that has forced them to take supplemental oxygen.”

 

 

remdesivir / Generic mfg.
Gilead announces results from phase 3 trial of remdesivir in patients with moderate Covid-19 (Gilead Press Release) – Jun 1, 2020 – P3, N=237; SIMPLE (NCT04257656); “Gilead Sciences, Inc….today announced topline results from the Phase 3 SIMPLE trial….The study demonstrated that patients in the 5-day remdesivir treatment group were 65 percent more likely to have clinical improvement at Day 11 compared with those in the standard of care group….No new safety signals were identified with remdesivir across either treatment group….Remdesivir was generally well-tolerated in both the 5-day and 10-day treatment groups.”

 

 

Lilly begins world’s first study of a potential Covid-19 antibody treatment in humans (PRNewswire) – Jun 1, 2020 – “First patients have been dosed in a Phase 1 study of LY-CoV555, the lead antibody from Lilly’s collaboration with AbCellera; The placebo-controlled study will assess safety and tolerability in patients hospitalized with COVID-19 with results anticipated by the end of June; Should Phase 1 results show the antibody can be safely administered, Lilly will initiate a Phase 2 proof of concept study to assess efficacy in vulnerable populations….The company also plans to study the drug in a preventative setting, focusing on vulnerable patient populations…”

 

 

Fauci: Moderna’s Phase 3 Covid-19 Vaccine Trial Of 30,000 Individuals Will Begin In July (Forbes) – Jun 2, 2020 – “In an interview Tuesday with the editor of JAMA, Fauci said the trial will include primarily U.S. sites, but also include international sites enrolling 30,000 individuals in a ‘randomized placebo’ controlled trial of Moderna’s vaccine against the Coronavirus strain Covid-19. Moderna’s vaccine candidate is considered in the lead among several efforts by drug and vaccine makers in the battle against the deadly virus….But Fauci confirmed Tuesday the work to begin a much larger phase 3 trial are well underway and will begin early next month.”

 

US has two million Covid-19 vaccine doses “ready to go” upon approval, says Trump (The Hindu Business Line) – Jun 6, 2020 – “Moderna, Novavax and Pfizer are amid the five companies shortlisted. Moderna currently seems to be in the lead. The company is planning to enter phase three testing in July, Fauci had said earlier this week according to a Forbes report.”

 

Experts Voice Concerns Over US Government’s Program For COVID-19 Vaccine – Jun 6, 2020 – “In a televised interview with the CNN, Dr Peter Hotez…said on June 6 that there is a lot of ‘chaos and confusion’ regarding the federal government’s program. According to the sources cited by the international media outlet, the Warp Speed program under the Trump administration has selected five companies that would most likely to manufacture the COVID-19 vaccine…dr Anthony Fauci has said that he expects at least 100,000 doses of one vaccine made by the Moderna to be available in the US by 2020.”

 

AstraZeneca Targeting Over 2 Billion COVID-19 Vaccine Doses After Latest Deals (Eyewire News) – Jun 5, 2020 – “The deals include a $750-million agreement with CEPI and Gavi to support the manufacturing, procurement and distribution of 300 million doses of AZD1222, with delivery to begin by year’s end. CEPI said the doses would be ‘ringfenced’ for the so-called COVID-19 Vaccine Global Access Facility, if the vaccine is found to be safe and effective. Richard Hatchett…said ‘this partnership demonstrates how the COVID-19 Vaccine Global Access Facility will bring the private, public and third sectors together to make COVID-19 vaccines available to those who need them most.'”

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COVID-19 Top News – June 1, 2020

June 3, 2020

dendrimer N-acetyl-cysteine (OP-101) / Ashvattha Therap
Ashvattha Therapeutics subsidiary Orpheris announces FDA agreement to initiate phase 2 study evaluating OP-101 in severe Covid-19 patients (Businesswire) – May 28, 2020 – “Orpheris…today announced the U.S. Food and Drug Administration (FDA) has agreed to a Phase 2 clinical study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of OP-101 in patients with severe COVID-19….The Phase 2 clinical trial is a randomized, double-blind, placebo-controlled evaluation….An evaluation of reduction in pro-inflammatory markers (CRP, ferritin, and IL-6) after treatment with OP-101 is also included in the study….A single IV dose Phase 1 study of OP-101 (20 or 40 mg/kg) in normal healthy volunteers demonstrated that OP-101 is generally well tolerated in healthy subjects…”

 

APL-9 / Apellis
Apellis Initiates Phase 1/2 Study of APL-9 in Patients with Severe COVID-19 (GlobeNewswire, Apellis Pharmaceuticals, Inc.) – May 28, 2020 – “Apellis Pharmaceuticals….today announced that the company has initiated a Phase 1/2 clinical study of APL-9…in COVID-19 patients with respiratory failure including acute respiratory distress syndrome (ARDS)….Apellis initiated the Phase 1/2 study following preliminary results from its ongoing, non-interventional study in patients with ARDS secondary to COVID-19, which showed a substantial increase in the activation of the complement cascade….Apellis initiated the study upon clearance by the U.S. Food and Drug Administration, which expedited the review of the investigational new drug application for APL-9 in COVID-19.”

 

CERC-002 / Kyowa Hakko Kirin, Sanofi, Cerecor
Cerecor and Myriad Genetics Announce that Levels of LIGHT, a Novel Cytokine, Were Highly Correlated with Disease Severity and Mortality in COVID-19 ARDS Biomarker Study (GlobeNewswire, Cerecor Inc.) – May 26, 2020 – P=NA, N=77; “Cerecor Inc….and Myriad Genetics Inc….today announced that levels of novel cytokine, LIGHT, were highly correlated with disease severity and mortality in a COVID-19 acute respiratory distress syndrome (ARDS) biomarker study. The biomarker study was conducted using the serum samples of 47 hospitalized COVID-19 patients and 30 healthy controls from Hackensack Meridian Health Network….LIGHT levels were significantly elevated in the serum of hospitalized patients with COVID-19 versus healthy controls (p value < 0.0001). The highest LIGHT levels were found in patients who required ventilator support, particularly in patients over 60. Importantly, the data demonstrated elevated LIGHT levels were also strongly linked with mortality (p=0.02).”

 

interferon beta inhalation (SNG001) / Synairgen
Synairgen Completes Recruitment of Hospitalised Patients in COVID-19 Trial (GlobeNewswire, Synairgen plc) – May 28, 2020 – “Synairgen plc…is pleased to announce that recruitment of 100 hospitalised patients in its clinical trial of SNG001 (inhaled formulation of interferon-beta-1a) in COVID-19 patients has now been completed….A successful outcome will inform onwards progression of SNG001 in COVID-19 patients. Results from the hospital setting are expected in July 2020…”

 

stannous protoporphyrin (RBT-9) / Renibus Therap
Datatrak International, Inc. Partners with Renibus Therapeutics, Inc. for Upcoming COVID-19 Clinical Trial (GlobeNewswire, Datatrak International) – May 26, 2020 – “Datatrak International, Inc….announces a new partnership with Renibus Therapeutics, Inc. for their COVID-19 clinical trial….Renibus has been fast tracked by the FDA to begin a Phase 2 study to evaluate the effects of their drug, RBT-9 in COVID-19 patients who are at high-risk of deteriorating health due to age or comorbid conditions such as kidney or cardiovascular disease.”

 

TJM2 / I-Mab
I-Mab reports interim results from part 1 study for anti-GM-CSF antibody TJM2 to treat Covid-19 patients with -cytokine release syndrome (PRNewswire) – May 27, 2020 – P1/2, N=114; NCT04341116; Sponsor: I-Mab Biopharma; “I-Mab…today announced interim results….Part 1 of the study evaluated the safety and tolerability of TJM2 in a total of 24 patients…After comprehensive review and analysis, the DMC concluded that I-Mab can commence the Part 2 of the study as planned, indicating TJM2 is safe and well-tolerated in the severe COVID-19 patients in the study. The DMC also endorsed protocol changes….Part 2 of the study with a similar design to Part 1 will target the same patient population and is expected to be initiated shortly.”

 

ifenprodil (NP-120) / Algernon Pharma
Algernon Submits Investigational New Drug (IND) Application with U.S. FDA for Multinational Phase 2b/3 Human Study to Evaluate Ifenprodil for COVID-19 (GlobeNewswire, Algernon Pharmaceuticals) – May 25, 2020 – “Algernon Pharmaceuticals Inc….is pleased to announce that it has submitted an Investigational New Drug (IND) application with the U.S. FDA for its planned multinational Phase 2b/3 study of its re-purposed drug NP-120 (Ifenprodil) as a potential therapeutic treatment for patients with COVID-19….Once local ethics approvals have been received, the trial will begin as a Phase 2b study of an aggregate of 100 patients and with positive preliminary data, the clinical trial will move directly from a Phase 2b into a Phase 3 trial. The data will determine the number of expected patients needed to reach statistical significance in the Phase 3 trial.”

 

favipiravir / Generic mfg.; Arbidol (umifenovir) / Pharmstandard
Glenmark to commence new phase 3 clinical trial on combination of two anti-viral drugs favipiravir and umifenovir in hospitalized patients of moderate Covid-19 in India (PRNewswire) – May 26, 2020 – “Glenmark received approval from Indian regulator to initiate study….Glenmark Pharmaceuticals…announced a new randomized, open-label study to test the combined efficacy of two antiviral drugs Favipiravir and Umifenovir….The new combination clinical trial will be called FAITH….158 hospitalized patients of moderate COVID-19 infection will be enrolled in the combination study and randomized in two groups: one group receiving Favipiravir and Umifenovir (with standard supportive care); and one group receiving Favipiravir along with standard supportive care….Simultaneously Glenmark is conducting phase 3 clinical trials of Favipiravir as a COVID-19 monotherapy option with 150 patients…”

 

Actemra IV (tocilizumab) / Roche, JW Pharma; Veklury (remdesivir) / Gilead
Genentech initiates phase III clinical trial of Actemra plus remdesivir in hospitalized patients with severe Covid-19 pneumonia (Businesswire) – May 28, 2020 – “Genentech…today announced the initiation of a global Phase III, randomized, double-blind, multicenter study (REMDACTA) to evaluate the safety and efficacy of Actemra® (tocilizumab) plus the investigational antiviral remdesivir….The study is expected to begin enrolling in June with a target of approximately 450 patients globally, including the United States, Canada and Europe….Genentech is close to completing enrollment of the global randomized, double-blind, placebo-controlled Phase III clinical trial….Data from the REMDACTA trial are designed to supplement the COVACTA study.”

 

Fauci: ‘We Might Have A Vaccine By The End Of The Year’ (Forbes) – May 27, 2020 – “‘We have a good chance-if all the things fall in the right place-that we might have a vaccine that would be deployable by the end of the year, by November-December,’ Dr. Fauci said on CNN Wednesday morning. Fauci explained that the vaccine trials with Niaid are proceeding ‘at risk,’ meaning researchers are taking ‘the next steps before the results of the previous step,’ which can shorten the development process by months.”

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COVID-19 Top News – May 25, 2020

May 25, 2020

Octagam (intravenous normal human immunoglobulin) / Octapharma
FDA approves Octapharma USA Investigational New Drug Application for severe Covid-19 patients (Businesswire) – May 20, 2020 – “The U.S. Food and Drug Administration (FDA) has approved the investigational new drug (IND) application submitted by Octapharma USA for a phase three clinical trial on the efficacy and safety of Octagam® 10%….The primary objective of the randomized, double-blind, placebo-controlled, multicenter study is to determine if high-dose Octagam® 10% therapy will slow or stop respiratory deterioration….The study will begin immediately at approximately 10 U.S. research sites with the goal of enrolling about 54 adult patients diagnosed with COVID-19….Octapharma hopes to report study results by the third quarter of 2020.”

 

fingolimod / Generic mfg.
[VIRTUAL] Sphingosine 1-Phosphate Receptor Modulators as a Potential Treatment Option in COVID-19 Induced Acute Res- piratory Distress Syndrome: Mechanistic Insights and Benefit-Risk Assessment (EAN 2020) – May 24, 2020 – Abstract #C10; “S1P receptor modulators, such as fingolimod, may represent a potential treatment option to ameliorate immune responses against SARS-CoV-2 and merit further investigation following careful benefit-risk evaluation in this setting.”

 

bone marrow-derived mesenchymal stem cells / NantKwest
NantKwest announces FDA authorization of IND application for mesenchymal stem cell product for the treatment of severe Covid-19 patients (Businesswire) – May 18, 2020 – “NantKwest, Inc….today announced it has received authorization from the U.S. Food and Drug Administration (FDA) for an Investigational New Drug application to treat patients with acute respiratory distress syndrome (ARDS) caused by COVID-19 with BM-Allo.MSC….NantKwest has entered into an agreement with the National Marrow Donor Program….The Phase 1b, randomized, double-blind, placebo-controlled study will evaluate the safety and efficacy of BM-Allo.MSC versus current supporting care in treating patients with severe disease and requiring ventilator support (IND 019735). The therapeutic will be administered to a total of 45 patients receiving care in the critical care or ICU setting.”

 

mRNA-1273 / Moderna Therapeutics
Moderna announces positive interim phase 1 data for its mRNA vaccine (mRNA-1273) against novel coronavirus (Businesswire) – May 18, 2020 – P1, N=45; “Moderna, Inc….today announced positive interim clinical data of mRNA-1273….Dose dependent increases in immunogenicity were seen across the three dose levels, and between prime and boost within the 25 µg and 100 µg dose levels….Consistent with the binding antibody data, mRNA-1273 vaccination elicited neutralizing antibodies in all eight of these participants….Based on the interim Phase 1 data, the Moderna-led Phase 2 study will be amended to study two dose levels, 50 µg and 100 µg….The NIAID-led Phase 1 study is being amended to include a 50 µg dose….Moderna anticipates the dose for the Phase 3 study to be between 25 µg and 100 µg and expects Phase 3 trial initiation in July, subject to finalization of the clinical trial protocol.”

 

ChAdOx1 nCoV-19 / Jenner Institute, Vaccitech, AstraZeneca, University of Oxford, Oxford Biomedica
AstraZeneca advances response to global Covid-19 challenge as it receives first commitments for Oxford’s potential new vaccine (AstraZeneca Press Release) – May 21, 2020 – “AstraZeneca today received support of more than $1bn from the US Biomedical Advanced Research and Development Authority (BARDA)….The development programme includes a Phase III clinical trial with 30,000 participants and a paediatric trial….A Phase I/II clinical trial of AZD1222 began last month to assess safety, immunogenicity and efficacy in over 1,000 healthy volunteers aged 18 to 55 years across several trial centres in southern England. Data from the trial is expected shortly which, if positive, would lead to late-stage trials in a number of countries.”

 

AT-527 / Atea Pharma
Atea Pharmaceuticals Announces IND Clearance of AT-527 for COVID-19 and $215 Million Financing (GlobeNewswire, Atea Pharmaceuticals, Inc.) – May 20, 2020 – “Atea Pharmaceuticals, Inc….today announced a $215 million Series D financing. The financing was led by Bain Capital Life Sciences and also included new investors….Atea also announced today that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug application (IND) for AT-527, a novel, oral, purine nucleotide prodrug, for the treatment of adult patients hospitalized with moderate COVID-19 disease, with one or more risk factors for poor outcomes. A Phase 2 clinical trial, scheduled to begin shortly, will evaluate the safety and efficacy of AT-527 in this patient population.”

 

Veklury (remdesivir) / Gilead
Beximco Pharma introduces world’s first generic remdesivir for Covid-19 treatment (The Financial Express) – May 21, 2020 – “Beximco Pharmaceuticals on Thursday announced the launch of Remdesivir…for treatment of COVID-19 patients….Beximco Pharma, listed on the Alternate investment Market (AIM) of London Stock Exchange, was the first company in Bangladesh to apply for regulatory approval, duly completing all the processes, strictly in compliance with local regulations. Following thorough evaluation, Directorate General of Drug Administration (DGDA) granted Emergency Use Authorization to Beximco Pharma’s Remdesivir IV Injection (under the brand name Bemsivir) on 21 May 2020.”

 

favipiravir / Generic mfg.
Health Canada clears Appili Therapeutics’ phase 2 clinical trial evaluating favipiravir as a prophylactic agent against Covid-19 outbreaks (Businesswire) – May 21, 2020 – “Appili Therapeutics Inc….today announced that Health Canada provided regulatory clearance for Appili’s Phase 2 study evaluating FUJIFILM Toyama Chemical’s (FFTC) favipiravir as a preventative measure against COVID-19 outbreaks….Appili expects trial recruitment to begin imminently….The partially blinded, cluster randomized placebo-controlled trial (cluster-RCT) will recruit approximately 760 participants across 16 LTCHs in Ontario.”

 

Alzumab (itolizumab) / Biocon, Equillium
Cuba credits two drugs with slashing coronavirus death toll (Reuters) – May 22, 2020 – “Communist-run Cuba said this week that use of two drugs produced by its biotech industry that reduce hyper-inflammation in seriously ill COVID-19 patients has sharply curbed its coronavirus-related death toll….One is itolizumab, a monoclonal antibody produced in Cuba and elsewhere. The other is a peptide that Cuba says its biotech industry discovered and has been testing for rheumatoid arthritis….’In Cuba, with the use of these drugs, 80 percent of those who end up in critical or serious condition are being saved’….Scientists caution that large placebo-controlled studies are needed to assess the safety and efficacy of these drugs for treating COVID-19.”

 

Vicromax (merimepodib) / BioSig Tech
FDA Clears the Investigational New Drug Application to Enable the Phase II Trial of ViralClear’s Merimepodib, Oral Solution to Treat Adult Patients with Advanced COVID-19, to Proceed (GlobeNewswire, BioSig Technologies, Inc.) – May 18, 2020 – “Phase II clinical trial expected to be conducted at multiple centers in the United States, including three Mayo Clinic sites under the leadership of Andrew D. Badley, M.D., Enterprise Chair of COVID-19 Task Force….ViralClear Pharmaceuticals, Inc. (ViralClear), today announced that the U.S. Food and Drug Administration (FDA) has completed its review of ViralClear’s Investigational New Drug (IND) application. The FDA informed ViralClear that it may proceed with a proposed phase II study of merimepodib oral solution in adults with COVID-19 who are hospitalized and either require supplemental oxygen or are on non-invasive ventilation or high flow oxygen devices….The trial will occur in hospitalized patients who have confirmed infection with SARS-CoV-2 and require supplemental oxygen.”

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COVID-19 Top News – May 18, 2020

May 18, 2020

VPM1002 / Max Planck Institute, SAKK, Serum Institute of India
A Phase III, Double-blind, Randomized, Placebo-controlled Multicentre Clinical Trial to Assess the Efficacy and Safety of VPM1002 in Reducing Healthcare Professionals’ Absenteeism in the SARS-CoV-2 Pandemic by Modulating the Immune System (clinicaltrials.gov) – May 13, 2020 – P3; N=1200; Not yet recruiting; Sponsor: Vakzine Projekt Management GmbH

 

aviptadil intravenous (RLF-100) / Relief Therap, NeuroRx
Relief Therapeutics announces filing of IND for phase 2/3 clinical trial of inhaled RLF-100 targeting early Covid-19 lung injury (GlobeNewswire) – May 11, 2020 – “RELIEF THERAPEUTICS Holding AG…announced that its U.S. partner, NeuroRx Inc., has filed an investigational protocol…to conduct a Phase 2/3 clinical trial assessing inhaled RLF-100 as a treatment for patients with non-acute lung injury caused by the SARS-CoV-2 virus….The multicenter randomized placebo-controlled trial aims to enroll 144 patients with COVID-19 with shortness of breath and early pulmonary symptoms….The trial will be conducted in at least 20 sites. Patients will be randomized to receive inhaled RLF-100 plus standard of care or placebo plus standard of care. The primary endpoints will be progression to ARDS…”

 

Ampligen (rintatolimod) / AIM ImmunoTech
AIM Immunotech announces FDA authorization for first human Ampligen trial in Covid-19 patients with cancer; provides corporate business update for the first quarter of 2020 (Yahoo Finance) – May 14, 2020 – “AIM ImmunoTech…announced that the U.S. Food and Drug Administration has authorized the first human trial assessing the safety and effectiveness of the Company’s lead asset, Ampligen (rintatolimod), in combination with interferon alfa-2b, in cancer patients with COVID-19, the disease caused by the SARS-CoV-2 coronavirus….The new clinical trial, to be conducted at Roswell Park Comprehensive Cancer Center under the leadership of Pawel Kalinski….The phase 1/2b study will enroll approximately 40 patients in two stages.”

 

Veklury (remdesivir) / Gilead
EMA recommends expanding compassionate use of Gilead’s Covid-19 drug (TODAYonline) – May 12, 2020 – “The European Medicines Agency (EMA)…recommended that the compassionate use of Gilead Sciences Inc’s…experimental drug remdesivir be expanded so that more patients with severe COVID-19 can be treated….The agency, which last month started a rolling review of data on the use of remdesivir for COVID-19 treatment, said it also introduced a five-day course of the drug, alongside the longer 10-day course, for patients not requiring assisted ventilation.”

 

mosedipimod (EC-18) / Enzychem Lifesciences
Enzychem Lifesciences to start P2 trial of Covid-19 treatment (Korea Biomedical Review) – May 13, 2020 – “Enzychem Lifesciences said that the Ministry of Food and Drug Safety has approved its investigational new drug (IND) application to conduct phase 2 clinical trials of EC-18, a treatment candidate for Covid-19….Enzychem plans to speed up efforts to make a similar application to the U.S. Food and Drug Administration. The company will begin clinical trials to demonstrate the efficacy of EC-18 with several clinical institutions, including Chungbuk National University Hospital. The trial on 60 patients will be a double-blinded placebo-controlled trial to increase the value of efficacy data.”

 

mRNA-1273 / Moderna Therapeutics
Moderna receives FDA Fast Track designation for mRNA vaccine (mRNA-1273) against novel coronavirus (Businesswire) – May 12, 2020 – “Finalizing protocol for Phase 3 study of mRNA-1273, expected to begin in early summer of 2020….Moderna, Inc….today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the Company’s mRNA vaccine candidate (mRNA-1273) against the novel coronavirus (SARS-CoV-2)….Funding from the Biomedical Advanced Research and Development Authority (BARDA)…supported the planning for these studies and will also support the late-stage clinical development programs, as well as the scale-up of mRNA-1273 manufacturing both at the Company’s facilities and that of its strategic collaborator, Lonza Ltd.”

 

VERU-111 / Veru Inc
Veru Secures FDA Agreement to Initiate Phase 2 Study of VERU-111, Novel Microtubule Depolymerization Drug to Combat COVID-19 (GlobeNewswire, Veru Healthcare) – May 12, 2020 – “Veru Inc….today announced that it has received FDA permission to initiate a Phase 2 clinical trial to assess the efficacy of VERU-111, a microtubule depolymerization agent, in combating COVID-19….The Company met with FDA and received agreement on the clinical development program for VERU-111 as a potential dual antiviral and anti-inflammatory agent to combat COVID-19 under the new FDA program….The Phase 2 clinical trial is a double-blind randomized (1:1) placebo-controlled trial evaluating daily oral doses of VERU-111 versus placebo for 21 days in 40 hospitalized patients….The primary efficacy endpoint will be the proportion of patients that are alive and without respiratory failure at Day 29….The study is expected to commence in the next 2 weeks.”

 

Cuba works on new product to fight “Cytokine Storm” produced by Covid-19 (Escambray) – May 14, 2020 – “The Center of Molecular Immunology (CIM by its Spanish acronym) is working to obtain an antagonist of interleukin-6, a product that can be used to inhibit the so-called ‘cytokine storm’….The project is in its initial phase….Three of the drugs that make up the Cuban protocol for the treatment of COVID-19 are developed by the Center for Molecular Immunology: the monoclonal antibody Itolizumab, created to combat leukemias and lymphomas; the recombinant human erythropoietin, of proven efficacy in people with renal failure and, finally, the stem cell generating factor LeukoCIM.”

 

FDA approves Covid-19 trial after successful emergency use of umbilical stem cells from RESTEM (PRNewswire) – May 14, 2020 – “RESTEM…announced today it has received approval from the U.S. Food and Drug Administration (FDA) for a 60-patient Phase I/IIa study using umbilical cord mesenchymal stem cells to treat patients with severe cases of COVID-19. The study will be the first of its kind in the U.S….The randomized, placebo-controlled and blinded study will look at whether this may be a safe and effective treatment for patients hospitalized with severe cases of COVID-19….The study is expected to start enrolling patients from Baptist Health South Florida and Sanford Health this week….Sanford Health will also be a key strategic partner for this study.”

 

Dr. Anthony Fauci says there’s ’virtually no chance’ that COVID-19 will be eradicated (Business Insider) – May 12, 2020 – “Dr. Anthony Fauci said that there’s little chance that the novel coronavirus, which causes the disease COVID-19, will be completely eradicated in an interview with NBC Sports….’It is so transmissible, and it is so widespread throughout the world, that even if our infections get well-controlled and go down dramatically during the summer, there is virtually no chance it will be eradicated,’ Fauci said of the novel coronavirus.”

Read More …

COVID-19 Top News – May 11, 2020

May 11, 2020

aviptadil intravenous (RLF-100) / Relief Therap, NeuroRx
Relief Therapeutics announces filing of IND for phase 2/3 clinical trial of inhaled RLF-100 targeting early Covid-19 Lung Injury (GlobeNewswire) – May 11, 2020 – “RELIEF THERAPEUTICS Holding AG…announced that its U.S. partner, NeuroRx Inc., has filed an investigational protocol…to conduct a Phase 2/3 clinical trial assessing inhaled RLF-100 as a treatment for patients with non-acute lung injury caused by the SARS-CoV-2 virus….The multicenter randomized placebo-controlled trial aims to enroll 144 patients with COVID-19 with shortness of breath and early pulmonary symptoms….The trial will be conducted in at least 20 sites. Patients will be randomized to receive inhaled RLF-100 plus standard of care or placebo plus standard of care. The primary endpoints will be progression to ARDS…”

 

Veklury (remdesivir) / Gilead
Gilead announces approval of Veklury (remdesivir) in Japan for patients with severe Covid-19 (Gilead Press Release) – May 7, 2020 – “Gilead Sciences, Inc….today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has granted regulatory approval of Veklury® (remdesivir) as a treatment for SARS-CoV-2 infection…under an exceptional approval pathway….The approval is based on clinical data from the U.S. National Institute of Allergy and Infectious Diseases’ global Phase 3 trial, Gilead’s Phase 3 SIMPLE trial in patients with severe manifestations of COVID-19, and available data from Gilead’s compassionate use program, including patients in Japan.”

 

Olumiant (baricitinib) / Incyte, Eli Lilly, University of Colorado; Veklury (remdesivir) / Gilead
NIH clinical trial testing antiviral remdesivir plus anti-inflammatory drug baricitinib for Covid-19 begins (National Institute of Health) – May 8, 2020 – P=3, N=800; ACTT (NCT04280705); Sponsor : National Institute of Allergy and Infectious Diseases (NIAID); “A randomized, controlled clinical trial evaluating the safety and efficacy of a treatment regimen of the investigational antiviral remdesivir plus the anti-inflammatory drug baricitinib for coronavirus disease 2019 (COVID-19) has begun. The trial is now enrolling hospitalized adults with COVID-19 in the United States….Investigators currently anticipate enrolling more than 1,000 participants….The clinical trial is the next iteration of NIAID’s Adaptive COVID-19 Treatment Trial (ACTT)….That trial closed to enrollment….Their analysis showed that patients who received remdesivir had a statistically significant shorter time to recovery compared to patients who received placebo.”

 

otilimab (GSK3196165) / GSK
GSK taps experimental arthritis antibody to calm the cytokine storm hitting Covid-19 patients (FierceBiotech) – May 7, 2020 – “…U.K.-based Big Pharma says it has ‘identified’ a monoclonal antibody from its pipeline, anti-GM-CSF (granulocyte macrophage colony-stimulating factor) otilimab, as a ‘potential treatment for patients who have been hospitalised with severe pulmonary complications related to COVID-19’. It plans to start midstage testing in the coming weeks in around 800 patients in a randomized, placebo-controlled trial….’We believe that otilimab may be able to help to block the effects of one of the types of cytokine (known as GM-CSF). We plan to start a phase 2 clinical trial by the end of May.'”

 

Yeliva (opaganib) / RedHill
RedHill Biopharma Receives FDA Approval for COVID-19 Clinical Study with Opaganib in the U.S. (GlobeNewswire, RedHill Biopharma Ltd.) – May 8, 2020 – “RedHill Biopharma Ltd….today announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for a Phase 2a clinical study evaluating its investigational drug, opaganib (Yeliva®, ABC294640)1, in patients with confirmed moderate-to-severe SARS-CoV-2 infection….The randomized, double-blind, placebo-controlled Phase 2a study aims to enroll up to 40 patients….The Company expects to promptly initiate patient enrollment. Patients will be randomized at a 1:1 ratio to receive either opaganib or placebo on-top of standard-of-care. The primary objective of the study is to evaluate the reduction in total oxygen requirement over the course of treatment…”

 

TNX-1830 / Tonix; TNX-1820 / Tonix; TNX-1810 / Tonix
Tonix Pharmaceuticals Enters into Research Collaboration and Exclusive License Agreement with University of Alberta to Develop Novel Horsepox-Based Vaccines, TNX-1810, TNX-1820 and TNX-1830, for the Prevention of COVID-19 (GlobeNewswire, Tonix Pharmaceuticals Holding Corp.) – May 7, 2020 – “Tonix Pharmaceuticals Holding Corp….announced today a new research collaboration and exclusive licensing agreement for three new vaccines for the prevention of COVID-19….The new collaboration will develop three new potential vaccines to protect against COVID-19 based on the horsepox vector platform, but designed to express different SARS-CoV-2 antigens than TNX-1800, which is designed to express SARS-CoV-2 Spike protein….’We are excited to expand our pipeline and look forward to developing three additional potential vaccines, TNX-1810, TNX-1820 and TNX-1830 to protect against COVID-19’….Tonix has been granted an exclusive license from the University of Alberta for technology and patents related to TNX-1810, TNX-1820 and TNX-1830.”

 

favipiravir / Generic mfg.; Baculovirus Expression Vector System Based Coronovirus Vaccine / Shionogi
Japan drugmaker Shionogi aims to launch coronavirus vaccine in 2021 (The Mainichi) – May 8, 2020 – “Japanese pharmaceutical company Shionogi & Co. said Friday it aims to launch a vaccine for the novel coronavirus as early as fall next year, as it is preparing to begin clinical trials by the end of the year….Chugai Pharmaceutical Co., said Friday it has begun joint research on an antibody to fight COVID-19 with Singapore’s Agency for Science, Technology and Research. The study will focus on a potential therapeutic antibody discovered earlier by a research team at the agency….The government is also expected to approve the anti-flu drug Avigan…later in the month to be used for novel coronavirus patients.” ”

 

placenta-based cell therapy / Pluristem, Charite – University of Medicine Berlin
U.S. FDA Clears Pluristem’s IND Application for Phase II COVID-19 Study (GlobeNewswire, Pluristem Therapeutics, Inc.) – May 8, 2020 – “Pluristem Therapeutics Inc….announced today that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for a Phase II study of its PLX cells in the treatment of severe COVID-19 cases….The study, titled ‘A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Phase II Study to Evaluate the Efficacy and Safety of Intramuscular Injections of PLX-PAD for the Treatment of severe COVID-19’ will treat 140 adult patients that are intubated and mechanically ventilated….The primary efficacy endpoint of the study is the number of ventilator free days during the 28 days from day 1 through day 28 of the study…..A Clinical Trial Authorization (CTA) has also been filed in Europe for a Phase II COVID-19 trial, with the first European clinical sites planned in Germany and Italy.”

 

MetaBlok (lsalt peptide) / Arch Biopartners
Arch Biopartners Receives Health Canada Approval to Conduct COVID-19 Phase II Human Trial (GlobeNewswire, Arch Biopartners) – May 8, 2020 – “Arch Biopartners Inc….today announced it has received a No Objection Letter from Health Canada to conduct a Phase II human trial for its lead drug LSALT peptide (Metablok) to prevent organ inflammation experienced by patients with COVID-19. The Phase II trial will be a multicenter, randomized, double-blind, placebo-controlled, proof of concept study of LSALT peptide. The primary endpoint is to prevent the development of life threatening acute respiratory distress syndrome (ARDS) in….The trial will begin with the enrolment of 60 hospitalized patients who will receive either LSALT peptide or drug-free saline daily for up to 14 days….As a result of clinical interest to support the Phase II trial in the United States, Arch continues to be in dialogue with the U.S. Food and Drug Administration…”

 

Veklury (remdesivir) / Gilead
FDA grant remdesivir emergency use for COVID-19 after turbulent week (Medical News Today) – May 7, 2020 – “According to the company, 5 days of treatment had similar effects to 10 days of treatment in people with severe COVID-19. ‘These study results complement data from the placebo-controlled study of remdesivir conducted by the [NIAID] and help to determine the optimal duration of treatment with remdesivir,’ says…Dr. Merdad Parsey. ‘The study demonstrates the potential for some patients to be treated with a 5-day regimen, which could significantly expand the number of patients who could be treated with our current supply of remdesivir. This is particularly important in the setting of a pandemic, to help hospitals and healthcare workers treat more patients in urgent need of care’….Meanwhile, Dr. Fauci acknowledged that the drug was not a panacea and drew parallels to the early work around the drug AZT to treat HIV.”

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