COVID-19 Top News – July 6, 2020

Sylvant (siltuximab) / BeiGene, JazzEUSA 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) / BiophytisBiophytis 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, PfizerPfizer 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, SanofiRegeneron 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 InstituteINOVIO 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, SinopharmCovid-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."