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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