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Month: April 2020

COVID-19 Top News – April 30, 2020

April 30, 2020

Alinia (nitazoxanide) / Lupin, Romark Lab
Romark initiates phase 3 clinical trials of NT-300 for Covid-19 (PRNewswire) – Apr 27, 2020 – “Romark announced today it will initiate two clinical trials of its investigational new drug candidate NT-300 (nitazoxanide extended-release tablets) for prevention of COVID-19….The first trial is designed to enroll 800 elderly residents of long-term care facilities following reports of the first case of COVID-19 at the sites. The second will enroll 800 healthcare workers who are at risk of exposure to the SARS-CoV-2 coronavirus….In addition to these prevention studies, Romark plans to conduct a third clinical trial of NT-300 for the early treatment of COVID-19 and other viral respiratory illnesses.”

 

remdesivir (GS-5734) / Gilead
Gilead announces results from phase 3 trial of investigational antiviral remdesivir in patients with severe Covid-19 (Gilead Press Release) – Apr 29, 2020 – P3, N=237; SIMPLE (NCT04257656); Sponsor: Capital Medical University; “Gilead Sciences, Inc….today announced topline results….The study demonstrated that patients receiving a 10-day treatment course of remdesivir achieved similar improvement in clinical status compared with those taking a 5-day treatment course….No new safety signals were identified with remdesivir across either treatment group….Outside of Italy, the overall mortality rate at Day 14 was 7 percent (n=23/320) across both treatment groups, with 64 percent (n=205/320) of patients experiencing clinical improvement at Day 14 and 61 percent (n=196/320) of patients discharged from the hospital….A second SIMPLE trial….The results from the first 600 patients of this study are expected at the end of May.”

 

dociparstat sodium (CX-01) / Chimerix
Chimerix Announces Initiation of a Phase 2/3 Study of DSTAT in Acute Lung Injury for Patients with Severe COVID-19 (GlobeNewswire, Chimerix, Inc.) – Apr 29, 2020 – “FDA Clearance to Proceed with Phase 2/3 Randomized, Double-Blind, Placebo Controlled Study….Chimerix…today announced the Company’s initiation of a Phase 2/3 study of dociparstat sodium (DSTAT) in COVID-19 patients with acute lung injury (ALI)….The study is a 1:1 randomized, double-blind, placebo-controlled, Phase 2/3 trial to determine the safety and efficacy of DSTAT in adults with severe COVID-19 who are at high risk of respiratory failure….The Phase 2 portion of the study will enroll 24 subjects to confirm the maximum safe dose and will then expand by an additional 50 patients (74 total) at the selected dose….Contingent upon positive results, the Phase 3 portion of the study will enroll approximately 45.”

 

CAP-1002 / Capricor
New Capricor Data Reports 100 Percent Survival in Critical COVID-19 Patients Treated with CAP-1002 (GlobeNewswire, Capricor Therapeutics) – Apr 29, 2020 – “Capricor Therapeutics…announced today new data reporting 100 percent survival in critical COVID-19 patients who were treated with Capricor’s lead asset…at Cedars-Sinai Medical Center as part of six compassionate care cases. Over the course of one month, six critically ill COVID-19 patients…were safely treated with CAP-1002. Of the six patients treated, four of them have been discharged. Following a review of the available data, the U.S. Food and Drug Administration (FDA) approved the Company’s expanded access protocol to treat up to 20 additional COVID-19 patients. There is also a randomized, placebo-controlled trial planned to treat patients…”

 

trabedersen (OT-101) / Autotelic, Mateon Therapeutics
Mateon Announces the Filing of an IND with US FDA to Evaluate its Antisense Drug Candidate OT-101 in COVID-19 patients (GlobeNewswire, Mateon Therapeutics) – Apr 27, 2020 – “Mateon Therapeutics Inc….announced today it has submitted an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) to study its investigational drug, OT-101, for the treatment of COVID-19 pandemic. The proposed randomized, double-blind, placebo-controlled Phase 2 study is intended to evaluate the safety and efficacy of OT-101 in adult patients hospitalized with COVID-19 and pneumonia in the US….’We look forward to collaborating closely with leading clinical investigators and the FDA to validate the effectiveness of OT-101 in treating COVID-19 in a controlled clinical setting.'”

 

Kevzara (sarilumab) / Asahi Kasei, Regeneron, Sanofi
Sanofi and Regeneron provide update on U.S. Phase 2/3 adaptive-designed trial in hospitalized COVID-19 patients (GlobeNewswire, Sanofi) – Apr 27, 2020 – “Sanofi and Regeneron Pharmaceuticals, Inc….today announced the preliminary results from the Phase 2 portion of an ongoing Phase 2/3 trial evaluating Kevzara® (sarilumab), an interleukin-6 (IL-6) receptor antibody, in hospitalized patients with “severe” or “critical” respiratory illness caused by COVID-19. Following a review by the Independent Data Monitoring Committee (IDMC) of all available Phase 2 and Phase 3 data, the trial will be immediately amended so that only ‘critical’ patients continue to be enrolled to receive Kevzara 400 mg or placebo….Preliminary analysis of the Phase 2 portion of the trial demonstrated that Kevzara rapidly lowered C-reactive protein, a key marker of inflammation, meeting the primary endpoint…”

 

mRNA-1273 / Moderna Therapeutics
Moderna announces IND submitted to U.S. FDA for phase 2 study of mRNA vaccine (mRNA-1273) against novel coronavirus (Businesswire) – Apr 28, 2020 – “Moderna, Inc….today announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for the company’s mRNA vaccine candidate (mRNA-1273) against the novel coronavirus (SARS-CoV-2)….Moderna has received initial feedback from the FDA on the design of the planned Phase 2 study, which is expected to begin in the second quarter of 2020. This study will evaluate the safety, reactogenicity and immunogenicity of two vaccinations of mRNA-1273 given 28 days apart.”

 

ChAdOx1 nCoV-19 / Jenner Institute, University of Oxford, Vaccitech, Oxford Biomedica
India’s Serum Institute gears up to make millions of doses of potential Covid-19 vaccine (News-Medical) – Apr 28, 2020 – “The Serum Institute of India plans to start manufacturing Oxford University’s Covid-19 vaccine in 3 weeks to get a head start on production, the company announced….Serum Institute of India is now collaborating with Codagenix…for a live attenuated vaccine candidate. The vaccine is in the preclinical stage, being tested on mice and primates. The project is estimated to cost around $41.9 million and to be in the market by early 2022….Animal trials on mice and primates are in the planning stage, and human trials should begin in September if all goes well….The vaccine will sell at around Rs. 1000 in India, he says, enough to cover the firm’s production costs.”

 

Merck and Institute for Systems Biology collaborate to define molecular mechanisms of SARS-CoV-2 infection and identify potential prognostic biomarkers (Businesswire) – Apr 27, 2020 – “Merck…and the Institute for Systems Biology (ISB), today announced a new research collaboration to investigate and define the molecular mechanisms of SARS-CoV-2 infection and COVID-19 and identify targets for medicines and vaccines. Merck has also entered into an agreement with the Biomedical Advanced Research and Development Authority (BARDA)…for BARDA to provide funding support for this research….’This collaboration with Merck provides critical support for the recently launched scientific trial being co-led by ISB and Swedish Medical Center, both part of the Providence St. Joseph Health network.'”

 

COVID-19 S-Trimer vaccine / Sichuan Clover Biopharma
CEPI announces COVID-19 vaccine development partnership with Clover Biopharmaceuticals’ Australian subsidiary (Businesswire) – Apr 27, 2020 – “Richard Hatchett…said: ‘We are delighted to partner with Clover Australia on their innovative COVID-19 S-Trimer vaccine candidate. They produced their vaccine within a month of the virus sequence becoming available, and they have rapidly advanced toward a first in human trial.'”

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COVID-19 Top News – April 27, 2020

April 27, 2020

Jakafi oral (ruxolitinib) / Novartis, Incyte
Phase 3 Randomized, Double-blind, Placebo-controlled Multi-center Study to Assess the Efficacy and Safety of Ruxolitinib in Patients With COVID-19 Associated Cytokine Storm (RUXCOVID) (clinicaltrials.gov) – Apr 24, 2020 – P3; N=402; Not yet recruiting; Sponsor: Novartis Pharmaceuticals

 

vafidemstat (ORY-2001) / Oryzon
Oryzon to initiate ESCAPE: A phase II clinical trial to test efficacy of vafidemstat in severely ill Covid-19 patients (GlobeNewswire) – Apr 24, 2020 – “Oryzon Genomics, S.A….it has received approval from the Spanish Drug Agency (AEMPS) to conduct a Phase II clinical trial with vafidemstat in seriously ill COVID-19 patients. The study, named ESCAPE (Efficacy and Safety of a Combined treatment with vafidemstat to prevent ARDS in adult Patients with severE COVID-19)…is an open-label, randomized, double-arm Phase II trial to assess the efficacy and tolerability of vafidemstat….Initially, it is planned to include 20 patients in each arm of the trial. In principle, initially two hospitals will participate (H. Valle de Hebrón and H. del Mar, both in Barcelona, Spain), while more centers can be added if necessary.”

 

Vicromax (merimepodib) / BioSig Tech
BioSig subsidiary ViralClear submits Investigational New Drug application to the FDA for phase II clinical trials for merimepodib, an orally administered treatment for patients with Covid-19 (GlobeNewswire) – Apr 24, 2020 – “BioSig Technologies, Inc….today announced that its subsidiary ViralClear Pharmaceuticals, Inc. submitted an Investigational New Drug (IND) Application to the Food and Drug Administration (FDA) for its Phase II clinical trial with Merimepodib as a treatment for COVID-19. The study will be a randomized, placebo-controlled trial to evaluate the efficacy and safety of Merimepodib in patients with COVID-19. The placebo-controlled Phase II clinical trial calls for 20 planned patients from three Mayo Clinic sites….Data from the Phase II trial is expected within three months of the commencement of the trial.”

 

bucillamine / Revive Therap
Revive Therapeutics announces U.S. FDA recommendation to proceed directly into a phase 3 confirmatory clinical trial (GlobeNewswire) – Apr 23, 2020 – “Revive Therapeutics Ltd….announced today that it has received positive feedback….The FDA recommended that the Company proceed directly into a Phase 3 confirmatory clinical trial (‘Phase 3 study’) to evaluate Bucillamine for the treatment of patients with mild-moderate COVID-19….FDA provided valuable guidance on study design and outcome measures for the Phase 3 study….The Company…actively incorporating the pre-IND meeting guidance and preparing the package for submission to the FDA. The Company expects to file the final IND within the next 60 days and will plan to initiate the Phase 3 study thereafter.”

 

Baxter obtains U.S. FDA emergency use authorization for Oxiris blood purification filter for Covid-19 treatment (Baxter Press Release) – Apr 24, 2020 – “Baxter International Inc….announced it has received emergency use authorization (EUA) from the U.S. FDA for the company’s Oxiris filter set to treat patients who have confirmed COVID-19 and have been admitted to the intensive care unit (ICU) with confirmed or imminent respiratory failure in need of blood purification therapy to reduce pro-inflammatory cytokine levels, including use in continuous renal replacement therapy (CRRT).”

 

DiaSorin obtains FDA emergency use authorization and BARDA funding for SARS-CoV-2 IgG serology kit for Covid-19 testing in the U.S. (PRNewswire) – Apr 25, 2020 – “DiaSorin…announced today that it has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration for the LIAISON® SARS-CoV-2 S1/S2 IgG test….DiaSorin recently signed a contract with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services to obtain funding aimed at making the test available in the U.S.”

 

MetaBlok (lsalt peptide) / Arch Biopartners
Arch Biopartners Submits Application to Health Canada to Conduct COVID19 Phase II Human Trial for Metablok to Prevent Lung and Kidney Inflammation (GlobeNewswire, Arch Biopartners) – Apr 23, 2020 – “Arch Biopartners Inc….today announced it has submitted a Clinical Trial Application to Health Canada for a Phase II human trial for its lead drug Metablok (LSALT peptide) to prevent lung and kidney inflammation in patients with COVID19. The Phase II trial will be a multicenter, randomized, double-blind, placebo-controlled, proof of concept study of LSALT peptide….As a result of clinical interest to support the Phase II trial in the United States, Arch will be preparing an application to the U.S. Food and Drug Administration as well as other authorities within the American hospital system.”

 

Ortho launches second Covid-19 antibody test with 100% specificity (PRNewswire) – Apr 25, 2020 – “Ortho Clinical Diagnostics…today introduced and announced the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization to its second COVID-19 antibody test—the VITROS® Immunodiagnostic Products Anti-SARS-CoV-2 IgG Test (COVID-19 IgG antibody test)….Ortho plans to manufacture several million COVID-19 IgG antibody tests each month.”

 

remdesivir (GS-5734) / Gilead
Gilead Sciences statement on data from remdesivir study in patients with severe COVID-19 in China (Gilead Press Release) – Apr 23, 2020 – “‘Today, information from the first clinical study evaluating the investigational antiviral remdesivir in patients with severe COVID-19 disease in China was prematurely posted on the World Health Organization website….We also anticipate data at the end of May from NIAID’s double-blind, placebo-controlled study of remdesivir in patients across a range of disease severity.”

 

WHO warns against coronavirus “immunity passports” due to reinfection concerns (Vox) – Apr 25, 2020 – “Lipsitch says based on current evidence and what the scientific community knows about similar viruses, it’s only possible to make ‘an educated guess’ as to immunity: ‘After being infected with SARS-CoV-2, most individuals will have an immune response, some better than others. That response, it may be assumed, will offer some protection over the medium term – at least a year – and then its effectiveness might decline,’ he wrote….And earlier in April, Anthony Fauci…said it’s ‘possible’ that the US would consider such a policy in the future. ‘I mean, it’s one of those things that we talk about when we want to make sure that we know who the vulnerable people are and not,’ he told CNN on April 10. ‘This is something that’s being discussed. I think it might actually have some merit, under certain circumstances.'”

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Weekly Top News – Ovarian Cancer – April 27, 2020

April 27, 2020

Tecentriq (atezolizumab) / Roche
Tecentriq: Regulatory submission in Japan for ovarian cancer in 2020 (Chugai) – Apr 23, 2020 – Q1 FY 2020 Results: Regulatory submission in Japan for early breast cancer in 2021; Regulatory submission in Japan for NSCLC (neoadjuvant) in 2023 or later

 

dostarlimab (TSR-042) / GSK; Zejula (niraparib) / GSK, ZAI Lab, J&J, Takeda
A Phase 3 Comparison of Platinum-based Therapy With TSR-042 and Niraparib Versus Standard of Care (SOC) Platinum-based Therapy as First-line Treatment of Stage III or IV Nonmucinous Epithelial Ovarian Cancer (clinicaltrials.gov) – Apr 22, 2020 – P3; N=1228; Recruiting; Sponsor: Tesaro, Inc.; N=912 –> 1228; Trial completion date: Jul 2023 –> Jan 2023; Trial primary completion date: Nov 2021 –> Jul 2021

 

Keytruda (pembrolizumab) / Merck (MSD); LY 3475070 / Eli Lilly
A Study of the CD73 Inhibitor LY3475070 Alone or in Combination With Pembrolizumab in Participants With Advanced Cancer (clinicaltrials.gov) – Apr 22, 2020 – P1; N=120; Suspended; Sponsor: Eli Lilly and Company; Recruiting –> Suspended

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Weekly Top News – IBD – April 27, 2020

April 27, 2020

etrolizumab (RG7413) / Roche
Etrolizumab: Regulatory submissions in US/EU for Crohn’s disease in 2022 (Roche) – Apr 22, 2020 – Q1 2020 Results

 

 

mirikizumab (LY3074828) / Eli Lilly
Mirikizumab: Primary completion of P3 LUCENT 2 trial (NCT03524092) in moderate-to-severe ulcerative colitis in Jun 2021 (Eli Lilly) – Apr 23, 2020 – Q1 2020 Results: Completion of P3 LUCENT 2 trial in moderate-to-severe ulcerative colitis in Jun 2023; Primary completion and completion of P3 LUCENT 3 trial (NCT03519945) in moderate-to-severe ulcerative colitis in Aug 2023

 

 

Alofisel (darvadstrocel) / Takeda
ADMIRE-CD-II: Study to Assess Efficacy and Safety of Cx601, Adult Allogeneic Expanded Adipose-derived Stem Cells (eASC) for the Treatment of Complex Perianal Fistula(s) in Participants With Crohn’s Disease (CD) (clinicaltrials.gov) – Apr 21, 2020 – P3; N=554; Active, not recruiting; Sponsor: Tigenix S.A.U.; Recruiting –> Active, not recruiting

 

mirikizumab (LY3074828) / Eli Lilly
Mirikizumab: Primary completion of P3 LUCENT 1 trial (NCT03518086) in moderate-to-severe ulcerative colitis in Sep 2020 (Eli Lilly) – Apr 23, 2020 – Q1 2020 Results: Completion of P3 LUCENT 1 trial in moderate-to-severe ulcerative colitis in Dec 2021 

 

 

mirikizumab (LY3074828) / Eli Lilly
Mirikizumab: Primary completion of P3 VIVID-1 trial (NCT03926130) for Crohn’s disease in Feb 2022 (Eli Lilly) – Apr 23, 2020 – Q1 2020 Results: Completion of P3 VIVID-1 trial for Crohn’s disease in Jul 2023; Primary completion and completion of P3 VIVID-2 trial (NCT04232553) for Crohn’s disease Nov 2023 

 

Entyvio (vedolizumab) / Takeda
Vedolizumab Intravenous (IV) Compared to Placebo in Chinese Participants With Crohn’s Disease (clinicaltrials.gov) – Apr 24, 2020 – P3; N=215; Active, not recruiting; Sponsor: Takeda; Trial primary completion date: Apr 2020 –> Sep 2020

 

Stelara (ustekinumab) / J&J
Stelara: Patent expiry in US in 2023 (J&J) – Apr 26, 2020 – Annual Meeting of Shareholders

 

Cimzia (certolizumab pegol) / Astellas, UCB, Eli Lilly
CHERISH: A Study in Pregnant Women With Chronic Inflammatory Diseases Treated With Cimzia (Certolizumab Pegol) (clinicaltrials.gov) – Apr 21, 2020 – P1b; N=20; Suspended; Sponsor: UCB Biopharma S.P.R.L.; Recruiting –> Suspended

 

Rinvoq (upadacitinib) / AbbVie
Rinvoq: Newly added patent in Orange Book (Orange Book) – Apr 22, 2020 – Expiry on October 17, 2036 

 

TD-1473 / J&J
Theravance Biopharma announces peer-reviewed publication highlighting TD-1473 program in the Journal of Crohn’s and Colitis (PRNewswire) – Apr 20, 2020 – “Theravance Biopharma…announced the publication of a peer-reviewed paper summarizing positive results from completed Phase 1 clinical and preclinical studies of TD-1473, the Company’s gut-selective pan-Janus kinase (JAK) inhibitor. The manuscript…highlights a broad collection of data demonstrating minimal systemic drug exposure, local target engagement, and trends toward reduced markers of ulcerative colitis disease activity following TD-1473 administration versus placebo.”

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Weekly Top News – Psoriasis – April 27, 2020

April 27, 2020

Tremfya (guselkumab) / J&J
Xi’an Janssen announces the first targeted interleukin 23 inhibitor Tenoya (gusakiyu mab) [Google translation] (Sina Corp) – Apr 21, 2020 – “Johnson & Johnson’s subsidiary in China, Xi’an Janssen Pharmaceutical Co., Ltd. recently announced that its Tenova (Gusakiyu monoclonal antibody injection, English trade name: TREMFYA, Guselkumab) has been launched in China and is used for systemic treatment….The China Red Cross Foundation launched the ‘Special Rebirth’ assistance project for patients with moderate to severe plaque psoriasis, providing Tenova (Gusai) to patients with moderate to severe plaque psoriasis with low income and low security Chiyuzumab injection) drug assistance.”

 

bimekizumab (UCB4940) / UCB
BE COMPLETE: A Study to Evaluate the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis (clinicaltrials.gov) – Apr 20, 2020 – P3; N=390; Suspended; Sponsor: UCB Biopharma S.P.R.L.; Recruiting –> Suspended

 

bimekizumab (UCB4940) / UCB; Humira (adalimumab) / Eisai, AbbVie
BE OPTIMAL: A Study to Test the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis (clinicaltrials.gov) – Apr 20, 2020 – P3; N=840; Suspended; Sponsor: UCB Biopharma S.P.R.L.; Recruiting –> Suspended

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
AbbVie announces the availability in Spain of risankizumab [Google translation] (ConSalud.es) – Apr 21, 2020 – “The biopharmaceutical company AbbVie announces the availability in Spain from April 1 of SKYRIZI (risankizumab) for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic treatment….This approval is based on the robust clinical development that includes the pivotal phase III studies: UltIMMa-1, UltIMMa-2, IMMvent and IMMhance, which have evaluated the long-term safety and efficacy of this new treatment in more than 2,100 patients with moderate to severe plaque psoriasis.” ”

 

Taltz (ixekizumab) / Eli Lilly
Lilly reports strong first-quarter financial results, adjusts EPS guidance (Eli Lilly Press Release) – Apr 23, 2020 – P4, N=1,028; IXORA-R (NCT03573323); Sponsor: Eli Lilly and Company; “The company completed a Phase 4 study of Taltz in patients with moderate to severe psoriasis. Taltz demonstrated non-inferiority to guselkumab on the final secondary endpoint at week 24. As previously disclosed, Taltz achieved superiority compared to guselkumab on all primary and key secondary endpoints at week 12.”

 

mirikizumab (LY3074828) / Eli Lilly
Eli Lilly and Company (LLY) CEO Dave Ricks on Q1 2020 results – Earnings call transcript (SeekingAlpha) – Apr 23, 2020 – P3, N=530; OASIS-1 (NCT03482011); P3, N=1,443; OASIS-2 (NCT03535194); Sponsor: Eli Lilly and Company; “We also announced the first of two Phase 3 trials studying mirikizumab in psoriasis met its primary endpoints…We announced that mirikizumab met all the co-primary and key secondary endpoints in the first OASIS-1 trial, which is the placebo-controlled 52 weeks trial in psoriasis.”

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
A Study to Assess the Safety and Efficacy of Risankizumab for Maintenance in Moderate to Severe Plaque Type Psoriasis ( LIMMITLESS ) (clinicaltrials.gov) – Apr 24, 2020 – P3; N=2171; Active, not recruiting; Sponsor: AbbVie; Enrolling by invitation –> Active, not recruiting

 

mirikizumab (LY3074828) / Eli Lilly
Mirikizumab: Primary completion of P3 OASIS-2 trial (NCT03535194) in moderate-to-severe plaque psoriasis in Mar 2020 (Eli Lilly) – Apr 23, 2020 – Q1 2020 Results: Completion of P3 OASIS-2 trial in moderate-to-severe plaque psoriasis in Dec 2020; Primary completion and completion of P3 OASIS-3 trial (NCT03556202) in moderate-to-severe plaque psoriasis in May 2024 

 

 

Simponi (golimumab) / Merck (MSD), Mitsubishi Tanabe, J&J
Janssen announces submission of two applications to U.S. FDA seeking approval of Simponi Aria (golimumab) for the treatment of polyarticular juvenile idiopathic arthritis and juvenile psoriatic arthritis (PRNewswire) – Apr 24, 2020 – “The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of two supplemental Biologics License Applications (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of SIMPONI ARIA® (golimumab) for the treatment of polyarticular juvenile idiopathic arthritis (pJIA) and juvenile psoriatic arthritis (jPsA), in patients two years of age and older in combination with methotrexate….The submissions are based on results from the GO-VIVA Phase 3 clinical trial, which…assess the pharmacokinetics, safety and efficacy of SIMPONI ARIA in children with pJIA ages two to 17 years who had active arthritis in five or more joints…”

 

Stelara (ustekinumab) / J&J
Stelara: Patent expiry in US in 2023 (J&J) – Apr 26, 2020 – Annual Meeting of Shareholders

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COVID-19 Top News – April 23, 2020

April 23, 2020

BNT162 / Pfizer, BioNTech
BioNTech and Pfizer announce regulatory approval from German authority Paul-Ehrlich-Institut to commence first clinical trial of COVID-19 vaccine candidates (GlobeNewswire, BioNTech SE) – Apr 22, 2020 – “BioNTech SE…and Pfizer Inc….have announced today that the German regulatory authority, the Paul-Ehrlich-Institut, has approved the Phase 1/2 clinical trial for BioNTech’s BNT162 vaccine program to prevent COVID-19 infection….The trial is the first clinical trial of a COVID-19 vaccine candidate to start in Germany, and is part of a global development program. Pfizer and BioNTech will also conduct trials for BNT162 in the United States upon regulatory approval, which is expected shortly….The dose escalation portion of the Phase 1/2 trial will include approximately 200 healthy subjects…aiming to determine the optimal dose for further studies as well as evaluate the safety and immunogenicity of the vaccine. The study will also evaluate the effects of repeated immunization for three of the four vaccine candidates which utilize uRNA or modRNA.”

 

Stalaris (ATYR1923) / aTyr Pharma, Kyorin
aTyr Pharma Announces Phase 2 Study of ATYR1923 in COVID-19 Patients with Severe Respiratory Complications Following FDA Acceptance of IND Application (GlobeNewswire, aTyr Pharma, Inc.) – Apr 21, 2020 – “aTyr Pharma, Inc…today announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application to evaluate its lead therapeutic candidate, ATYR1923, in a Phase 2 study in COVID-19 patients with severe respiratory complications. The Phase 2 clinical trial will be a randomized, double blind, placebo-controlled study with ATYR1923 in 30 confirmed COVID-19 positive patients at up to 10 centers in the United States. Patients enrolled in the trial will be assigned to one of three cohorts of 10 patients each. Patients will receive a single intravenous (IV) dose of either 1.0 or 3.0 mg/kg ATYR1923 or placebo.”

 

ReiThera, Leukocare and Univercells announce Pan-European Consortium for the fast-track development of a single-dose adenovirus-based Covid-19 vaccine (PRNewswire) – Apr 23, 2020 – “Italian ReiThera Srl. (Rome), German LEUKOCARE AG (Munich), and Belgian Univercells S.A. (Brussels), today announced a strategic collaboration for the development and large-scale manufacturing of a novel adenoviral vector-based vaccine against COVID-19….ReiThera is currently preparing for a COVID-19 first-in-human trial to be started in Italy in summer 2020….LEUKOCARE contributes to the drug product development by developing a highly stable liquid vaccine formulation based on its well-established technology platform for formulations of viruses and viral vectors.”

 

Xpovio (selinexor) / Ono Pharma, Karyopharm, Antengene
Karyopharm Announces Dosing of First Patient in Randomized Study Evaluating Low Dose Selinexor in Patients with Severe COVID-19 (GlobeNewswire, Karyopharm Therapeutics Inc.) – Apr 20, 2020 – “Karyopharm Therapeutics Inc….today announced dosing of the first patient in a randomized Phase 2 clinical study evaluating low dose oral selinexor in hospitalized patients with severe COVID-19. This global study is expected to enroll approximately 230 patients at clinical sites in the U.S., Europe, and Israel. Selinexor is an oral selective inhibitor of nuclear export (SINE) compound which blocks the cellular protein XPO1 which is involved in both the replication of SARS-CoV-2, the virus that causes COVID-19, and in the inflammatory response to the virus.”

 

Ultomiris IV (ravulizumab IV) / Alexion Pharma
Alexion announces plans to initiate phase 3 Study of Ultomiris(ravulizumab-cwvz) in hospitalized patients with severe Covid-19 (Businesswire) – Apr 20, 2020 – “Alexion Pharmaceuticals, Inc….today announced plans to initiate a global Phase 3 study to investigate ULTOMIRIS® (ravulizumab-cwvz) in a subset of adults with COVID-19….The study is expected to enroll approximately 270 patients across countries with high numbers of diagnosed cases, beginning in May, and will evaluate the impact of ULTOMIRIS….This follows the U.S. Food and Drug Administration’s (FDA) rapid review and acceptance of Alexion’s investigational new drug (IND) application for ULTOMIRIS for severe COVID-19.”

 

Farxiga (dapagliflozin) / Ono Pharma, AstraZeneca
AstraZeneca and Saint Luke’s Mid America Heart Institute initiate phase III DARE-19 trial with Farxiga in Covid-19 patients (AstraZeneca Press Release) – Apr 23, 2020 – “AstraZeneca and Saint Luke’s Mid America Heart Institute have initiated a randomised, global Phase III trial to assess the potential of Farxiga (dapagliflozin) as a treatment in patients hospitalised with COVID-19 who are at risk of developing serious complications, such as organ failure. The goal of the trial, called DARE-19, is to assess whether Farxiga…in patients who also have cardiovascular (CV), metabolic or kidney risk factors….The DARE-19 trial is open for enrolment in the US and other European countries with a high COVID-19 burden and aims to recruit approximately 900 patients.”

 

Oxford University coronavirus vaccine to begin human trials on Thursday as U.K. throws everything at vital breakthrough (Market Watch) – Apr 22, 2020 – “A coronavirus vaccine being developed by Oxford University will enter human trials as early as this Thursday, according to the U.K.’s health secretary. The U.K. government will provide £20 million ($24 million) to the university’s team and a further £22.5 million to Imperial College, where scientists are also working on a vaccine. Scientists at Oxford have previously said the aim is to produce a million doses of the vaccine by September.”

 

AT-H201 / Atossa Therap
Atossa Therapeutics Seeks Clinical Investigation Approval from FDA to Launch the COVID-19 HOPE Study (GlobeNewswire, Atossa Therapeutics, Inc.) – Apr 20, 2020 – “Atossa Therapeutics, Inc….has applied to the FDA for approval to commence a clinical study of its proprietary drug, AT-H201, in COVID-19 patients on mechanical ventilation….The goal of the clinical trial, called the HOPE Study, is to demonstrate improved lung function and reduce the amount of time that COVID-19 patients are on ventilators….’This is the first trial that I am aware of that is testing nebulized pharmaceuticals for patients on mechanical ventilation. Atossa looks forward to working on this important medical need and to reduce the death toll of COVID-19.'”

 

chloroquine phosphate / Generic mfg.; hydroxychloroquine / Generic mfg.; azithromycin / Generic mfg.
NIH panel recommends against drug combination promoted by Trump for COVID-19 (NPR) – Apr 21, 2020 – “‘The combination of hydroxychloroquine and azithromycin was associated with QTc prolongation in patients with COVID-19,’ the panel said….As for using the use of hydroxychloroquine or chloroquine alone, the panel said there was ‘insufficient clinical data to recommend either for or against.’ It reached the same conclusion about the drug remdesivir. The expert panel, convened by the NIH Institute that Dr. Anthony Fauci directs, produced a set of guidelines for doctors to use in treating COVID-19 patients. The panelists come from a variety of health care disciplines. For the most part, the guidelines are agnostic about the use of experimental medications, pointing out that strong scientific evidence is lacking to make a firm conclusion one way or the other.”

 

hydroxychloroquine / Generic mfg.; chloroquine phosphate / Generic mfg.
New U.S. treatment guidelines for Covid-19 don’t see much progress (The New York Times) – Apr 21, 2020 – “The federal agency led by Dr. Anthony Fauci issued guidelines on Tuesday that stated there is no proven drug for treating coronavirus patients…Months into the pandemic, a panel of experts convened by the research center Dr. Fauci leads, the National Institute of Allergy and Infectious Diseases, concluded that whenever possible, drug therapy should be given as part of a clinical trial, so that data can be collected to determine whether treatments work….Dr. Fauci has repeatedly pushed back at the president’s enthusiasm over the malaria drugs hydroxychloroquine and chloroquine, sometimes disagreeing in public with Mr. Trump.”

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COVID-19 Top News – April 20, 2020

April 20, 2020

lenzilumab (KB003) / Humanigen
Phase 3 Study to Evaluate Efficacy and Safety of Lenzilumab in Hospitalized Patients With COVID-19 Pneumonia (clinicaltrials.gov) – Apr 17, 2020 – P3; N=238; Not yet recruiting; Sponsor: Humanigen, Inc.

 

Farxiga (dapagliflozin) / Ono Pharma, AstraZeneca
DARE-19: Dapagliflozin in Respiratory Failure in Patients With COVID-19 (clinicaltrials.gov) – Apr 17, 2020 – P3; N=900; Recruiting; Sponsor: Saint Luke’s Health System

 

University of Waterloo to develop nasal vaccine for Covid-19 (Pharmaceutical-technology.com) – Apr 17, 2020 – “University of Waterloo researchers in Canada are developing a DNA-based vaccine candidate that can be given via nasal route to protect from Covid-19 infection. The vaccine will use bacteriophage-based approach…formulated to act on tissues in the nasal cavity and lower respiratory tract….A team led by Ho is designing the nanomedication, delivered by the nasal spray….Aucoin’s lab is constructing and purifying the VLP and working to enhance immunity after the initial administration of the vaccine. Slavcev’s research team…is now altering the system for Covid-19 application….A Natural Sciences and Engineering Research Council of Canada grant are supporting the research components.”

 

Vicromax (merimepodib) / BioSig Tech
Mayo Clinic preparing to Commence Phase II FDA clinical trial for the treatment of COVID-19 with Vicromax (GlobeNewswire, BioSig Technologies, Inc.) – Apr 16, 2020 – “IND filing with FDA expected in coming weeks with study initiation targeted for May 2020….Recently published in-vitro data demonstrated that Vicromax™ decreased viral production of SARS-CoV-2 by over 98%….BioSig Technologies, Inc….today announced that its subsidiary ViralClear Pharmaceuticals, Inc. updated its clinical development program for Vicromax™ (merimepodib, or MMPD) as a treatment for COVID-19. Under the terms of a new agreement, the Phase II clinical trial will be conducted at Mayo Clinic….The study will be a randomized, placebo-controlled trial. Data from the Phase II trial is expected within three months.”

 

Yeliva (opaganib) / RedHill
IND for Covid-19 with opaganib submitted to the FDA by RedHill Biopharma (GlobeNewswire) – Apr 17, 2020 – “RedHill Biopharma Ltd….today announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to study its investigational drug, opaganib (Yeliva®, ABC294640)1, for the treatment of SARS-CoV-2 infection (COVID-19). The IND submission follows preliminary discussions with the FDA on the study design. The proposed randomized, double-blind, placebo-controlled Phase 2a study is intended to evaluate the safety and efficacy of opaganib in up to 60 adult patients hospitalized with positive SARS-CoV-2 and pneumonia in the U.S.”

 

COV-ENT-1 / Enterin
Enterin to conduct a randomized phase 1/2a study in hospitalized patients with Covid-19 (PRNewswire) – Apr 17, 2020 – “Enterin, Inc….announced today that it has received feedback from the FDA laying out the path for a Phase 1/2a study in hospitalized patients with COVID-19 infection. The study will involve 10 U.S. sites and will enroll 80 hospitalized patients. Patients will have been diagnosed with SARS-CoV-2, have an SpO2 ≤94% or evidence of pneumonia by chest XR or CT scan. The first stage will involve 24 patients….The second stage will involve another 56 patients….The compound is administered by inhalation via standard nebulizer….Assuming Enterin is allowed to proceed with the study, it is anticipated that the study will begin within the next three months.”

 

mRNA-1273 / Moderna Therapeutics
Moderna announces award from U.S. government agency BARDA for up to $483 million to accelerate development of mRNA vaccine (mRNA-1273) against novel coronavirus (PipelineReview) – Apr 17, 2020 – “Moderna, Inc….today announced an agreement for a commitment of up to $483 million from the Biomedical Advanced Research and Development Authority (BARDA)…The Phase 1 open-label study…has completed enrollment of the original study….The NIH recently amended the Phase 1 protocol to include an additional six cohorts: three cohorts of older adults (ages 51-70) and three cohorts of elderly adults (age 71 and above). Enrollment for these cohorts is ongoing….Company intends to begin a Phase 2 study of mRNA-1273 under its own Investigational New Drug (IND) application in the second quarter of 2020. Subject to data from these studies and discussions with regulators, a Phase 3 study could begin as soon as fall, 2020.”

 

Roche develops new serology test to detect Covid-19 antibodies (Roche Press Release) – Apr 17, 2020 – “Roche…today announced the development and upcoming launch of its Elecsys® Anti-SARS-CoV-2 serology test to detect antibodies in people who have been exposed to the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) that causes the COVID-19 disease….Roche aims to have the antibody test available by early May in countries accepting the CE mark and is actively working with the FDA for an Emergency Use Authorisation. Roche is planning on an accelerated ramp up of monthly production to high double-digit million tests by June and will further scale up production as fast as possible.”

 

ThermoGenesis receives acknowledgement letter from FDA allowing its SARS-CoV-2 (Covid-19) IgM/IgG antibody fast detection kit for distribution (PRNewswire) – Apr 16, 2020 – “ThermoGenesis Holdings, Inc….announced today that…following submission of notification to the U.S. Food and Drug Administration (FDA), the Company has received the necessary acknowledgement letter which provided confirmation that the ThermoGenesis’ SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Kit has been appropriately validated….The required registrations and listings with FDA have been completed, which now allow the diagnostic kit to be distributed.”

 

INO-4800 / Inovio
IVI, INOVIO, and KNIH to partner with CEPI in a phase I/II clinical trial of INOVIO’s COVID-19 DNA vaccine in South Korea (International Vaccine Institute) – Apr 16, 2020 – “The International Vaccine (IVI) announced today that the Coalition for Epidemic Preparedness Innovations (CEPI) has granted $6.9 million funding to INOVIO (NASDAQ:INO) to work with IVI and the Korea National Institute of Health (KNIH) for Phase I/II clinical trial of INOVIO’s COVID-19 vaccine candidate (INO-4800) in South Korea….Dr. Richard Hatchett…said, ‘Developing a safe and effective vaccine and ensuring its global supply is our best exit strategy from the COVID-19 pandemic. CEPI is pleased to work with Inovio and IVI in this critical next stage of testing.'”

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Weekly Top News – Ovarian Cancer – April 20, 2020

April 20, 2020

Zejula (niraparib) / GSK, ZAI Lab, J&J, Takeda
Zai Lab announces China’s NMPA grants Priority Review to the sNDA for Zejula (niraparib) for first-line ovarian cancer maintenance treatment (GlobeNewswire) – Apr 16, 2020 – “Zai Lab Limited…announced that the Center for Drug Evaluation of China’s National Medical Products Administration (NMPA) has granted priority review status to the supplemental New Drug Application (sNDA) for ZEJULA (niraparib) as a maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy.”

 

 

AsiDNA (etidaligide) / Onxeo; Zejula (niraparib) / GSK, ZAI Lab, J&J, Takeda
Onxeo reports full-year 2019 financial results and provides business update (GlobeNewswire) – Apr 17, 2020 – “The study, sponsored by Gustave Roussy, will evaluate the effect of AsiDNA™ on the acquired resistance to PARP inhibitor niraparib in 2nd line maintenance treatment of relapsed ovarian is currently under review by the French agency (ANSM) and Ethics Committee. Assuming the recruitment can start from mid-year, the Company aims to obtain preliminary results by year-end 2020 or early in 2021….Proof-of-concept preclinical studies of OX401 are ongoing with results expected this year.”

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Weekly Top News – IBD – April 20, 2020

April 20, 2020

Entyvio (vedolizumab) / Takeda
EARLY-CD: ENTYVIO in Bio-naive Patients With Moderate/Severe Crohn’s Disease (CD) in Daily Practice (clinicaltrials.gov) – Apr 16, 2020 – P; N=140; Not yet recruiting; Sponsor: Takeda

 

Amjevita (adalimumab biosimilar) / Amgen, Daiichi Sankyo
Amgevita approved in Colombia (GaBI) – Apr 17, 2020 – “Amgen’s Amgevita (ABP 501) is the first producto bioterapéutico similar to be approved in Colombia for the treatment of complex diseases such as rheumatoid arthritis, Crohn’s disease and psoriasis.”

 

Stelara (ustekinumab) / J&J
SMC accepts four medicines for NHS use (PharmaTimes) – Apr 14, 2020 – “Janssen’s Stelara (ustekinumab) was endorsed by the SMC for the treatment of moderately to severely active ulcerative colitis…Stelara offers another treatment option and may help some patients to delay or avoid the need for surgery, the agency noted.”

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Weekly Top News – Psoriasis – April 20, 2020

April 20, 2020

Tremfya (guselkumab) / J&J
Tremfya: Regulatory approval in US/EU for psoriatic arthritis in 2020 (J&J) – Apr 14, 2020 – Key 2020 Events

 

 

Otezla (apremilast) / Amgen
Scalp psoriasis study data added to Otezla labeling (eMPR) – Apr 14, 2020 – “The labeling for Otezla (apremilast; Amgen) has been updated to include safety and efficacy information related to the treatment of patients with moderate to severe plaque psoriasis of the scalp….Results showed that a larger proportion of patients treated with Otezla had ScPGA response compared with placebo (43.3% vs 13.7%; treatment difference: 29.6%; 95% CI, 19.5-39.7). In addition, a greater percentage of Otezla-treated patients had Whole Body Itch NRS response and Scalp Itch NRS response (45.5% and 47.1%, respectively) vs placebo-treated patients (22.5% and 21.1%, respectively).”

 

Cosentyx (secukinumab) / Novartis
EXCEED 1: Efficacy of Secukinumab Compared to Adalimumab in Patients With Psoriatic Arthritis (clinicaltrials.gov) – Apr 14, 2020 – P3; N=854; Completed; Sponsor: Novartis Pharmaceuticals; Active, not recruiting –> Completed; Trial primary completion date: Sep 2019 –> Dec 2019

 

Amjevita (adalimumab biosimilar) / Amgen, Daiichi Sankyo
Amgevita approved in Colombia (GaBI) – Apr 17, 2020 – “Amgen’s Amgevita (ABP 501) is the first producto bioterapéutico similar to be approved in Colombia for the treatment of complex diseases such as rheumatoid arthritis, Crohn’s disease and psoriasis.”

 

Cosentyx (secukinumab) / Novartis
Novartis: Recent selloff has presented a buying opportunity (SeekingAlpha) – Apr 13, 2020 – “In 2019, Cosentyx reported revenues of $3.6 billion, a YoY jump of 28%. This is mainly driven by robust uptake in dermatology and rheumatology indications. Novartis now expects Cosentyx’s peak sales to exceed $5.0 billion.”

 

Otezla (apremilast) / Amgen
A Long-term Extension Study of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) – Apr 17, 2020 – P3b; N=140; Recruiting; Sponsor: Amgen; Not yet recruiting –> Recruiting

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
Efficacy and Safety of Tildrakizumab Compared to Placebo in Anti-TNF naïve Subjects With Active Psoriatic Arthritis II (INSPIRE 2) (clinicaltrials.gov) – Apr 13, 2020 – P3; N=292; Not yet recruiting; Sponsor: Sun Pharma Global FZE; N=50 –> 292

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
Efficacy and Safety of Tildrakizumab Compared to Placebo in Subjects With Active Psoriatic Arthritis I (INSPIRE 1) (clinicaltrials.gov) – Apr 13, 2020 – P3; N=472; Not yet recruiting; Sponsor: Sun Pharma Global FZE; N=200 –> 472

 

Cimzia (certolizumab pegol) / Astellas, UCB, Eli Lilly
CIMcare: A Study to Evaluate the Efficacy, Safety, and Drug Concentration of Certolizumab Pegol (CZP) in Children and Adolescent Study Participants With Moderate to Severe Chronic Plaque Psoriasis (PSO) (clinicaltrials.gov) – Apr 17, 2020 – P3; N=150; Suspended; Sponsor: UCB Biopharma S.P.R.L.; Recruiting –> Suspended

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