COVID-19 Top News – May 25, 2020

Octagam (intravenous normal human immunoglobulin) / OctapharmaFDA 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 / NantKwestNantKwest 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 TherapeuticsModerna 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 BiomedicaAstraZeneca 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 PharmaAtea 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) / GileadBeximco 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, EquilliumCuba 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 TechFDA 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."