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CD24Fc / OncoImmuneOncoImmune receives FDA approval for Covid-19 clinical trial (PipelineReview) - Apr 9, 2020 - "OncoImmune, Inc. has received a study-may-proceed letter from the FDA for its Phase III clinical trial testing the safety and efficacy of CD24Fc for the treatment of hospitalized COVID-19 patients (SAC-COVID). A cohort of 230 subjects with severe clinical symptoms will be randomized and administered a single dose of CD24Fc (480 mg IV infusion) or placebo and followed for a 14-day period to assess safety and efficacy in clinical improvement. The SAC-COVID trial consists of two interim analyses, respectively, for safety and therapeutic activity, and for therapeutic efficacy. This is a double blind, randomized, multi-center clinical trial."Avigan (favipiravir) / Fujifilm HoldingsFujifilm announces the start of a phase II clinical trial of its influenza antiviral drug Avigan Tablet for Covid-19 patients in the U.S. (PRNewswire) - Apr 9, 2020 - "FUJIFILM Corporation...announces the initiation of a U.S. phase II clinical trial to evaluate the safety and efficacy of its influenza antiviral drug "Avigan® Tablet" (generic name: favipiravir) for patients with COVID-19, a respiratory infection caused by the novel SARS-CoV-2 coronavirus....The clinical trial in the U.S. will enroll approximately 50 patients with COVID-19, in collaboration with Brigham and Women's Hospital, Massachusetts General Hospital, and the University of Massachusetts Medical School."CM4620 / CalciMedicaFDA grants CalciMedica permission to begin dosing CM4620-IE in patients with severe Covid-19 pneumonia under a newly opened IND (PipelineReview, CalciMedica) - Apr 11, 2020 - "CalciMedica Inc....today announced it has received a “Study May Proceed” letter from the U.S. Food and Drug Administration (FDA) to investigate the use of CM4620-IE in patients with severe COVID-19 pneumonia who are at risk for progression to acute respiratory distress syndrome (ARDS)....CalciMedica’s rapid receipt of notification from the FDA that it could proceed with its study is part of the agency’s initiative to expedite access to investigational drugs for the treatment COVID-19. The open-label Phase 2 clinical study aims to enroll 60 patients with severe COVID-19 pneumonia. Forty patients will be assigned to receive CM4620-IE plus standard of care and 20 assigned to receive standard of care alone. The first patients are being enrolled..."vazegepant (BHV-3500) / PortageBiohaven receives FDA may proceed letter to begin phase 2 trial of intranasal vazegepant to treat lung inflammation after Covid-19 infection (Biohaven Pharmaceuticals Press Release) - Apr 9, 2020 - "Phase 2 study to start within weeks, in collaboration with Thomas Jefferson University and other academic medical institutions....Biohaven Pharmaceutical Holding Company Ltd...today announced that it submitted Pre-IND/IND material to the U.S. Food and Drug Administration (FDA) to initiate a Phase 2 study of vazegepant, an intranasal, high-affinity calcitonin gene-related peptide (CGRP) receptor antagonist, for the treatment of COVID-19 infection associated pulmonary complications. The IND was approved by the Division of Pulmonary, Allergy, and Critical Care at FDA on April 8th and Biohaven was informed that the study may proceed immediately."BNT162 / Pfizer, BioNTechPfizer and BioNTech announce further details on collaboration to accelerate global Covid-19 vaccine development (GlobeNewswire) - Apr 9, 2020 - "The two companies plan to jointly conduct clinical trials for the COVID-19 vaccine candidates initially in the United States and Europe across multiple sites. BioNTech and Pfizer intend to initiate the first clinical trials as early as the end of April 2020, assuming regulatory clearance."Coronavirus vaccine developed by Oxford scientists could be available by September - Apr 13, 2020 - "A vaccine for COVID-19 could be ready in six months. According to Oxford professor Sarah Gilbert, her team has developed a vaccine that has the potential to protect people against the deadly disease, and it could be available for use by September....According to Gilbert, having a working vaccine available by September is possible if everything goes perfectly in the coming months. While her team has yet to conduct the clinical trial process, they are already in talks with the government about starting production of the vaccine before the final results become available."FDA authorizes Athersys to initiate a pivotal clinical trial evaluating Multistem cell therapy in patients with Covid-19 induced acute respiratory distress syndrome (Businesswire) - Apr 13, 2020 - "Athersys, Inc...announced today that the U.S. Food and Drug Administration (FDA) has authorized the Company to initiate a Phase 2/3 pivotal study to assess the safety and efficacy of MultiStem® therapy in subjects with moderate to severe acute respiratory distress syndrome (ARDS) induced by the novel coronavirus disease (COVID-19). This program falls under the current Investigational New Drug (IND) application for the Company’s completed MUST-ARDS study and, therefore, a new IND does not need to be filed. The Company plans to open the first clinical sites for recruitment of this MACOVIA (MultiStem Administration for COVID-19 Induced ARDS) study this quarter."leronlimab (PRO 140) / CytoDyn, Vyera PharmaBlood Samples at Day 0, 3 and 7 for Severely Ill COVID-19 Patients Clearly Indicate Leronlimab Has Significantly Reduced the Cytokine Storm in All (7) Patients and All Patients Demonstrated Immunological Benefit at Both Day 3 and Day 7 (GlobeNewswire, CytoDyn Inc.) - Apr 9, 2020 - "...CytoDyn, stated,'The Day-7 results from these patients demonstrates even more dramatic immune restoration especially in the CD8 T-lymphocyte population, the major immune cell responsible for eliminating virally infected cells'....'Critically ill patients are experiencing the benefit of extubating within 7 days of treatment with leronlimab'....Company is enrolling patients in two clinical trials, a Phase 2 trial for mild-to-moderate COVID-19 patients, and a Phase 2b/3 trial for severe and critically ill COVID-19 patients. The Phase 2b/3 clinical trial is for 390 patients, double blinded with 2:1 ratio (active drug to placebo ratio). Patients enrolled in this trial are expected to be administered leronlimab for two weeks with the primary endpoint being the mortality rate at 28 days and a secondary endpoint of mortality rate at 14 days. The Company will perform an interim analysis on the data from 50 patients."Lilly begins clinical testing of therapies for Covid-19 (Eli Lilly Press Release) - Apr 10, 2020 - "Lilly is also announcing...that it will advance LY3127804...to Phase 2 testing in pneumonia patients hospitalized with COVID-19 who are at a higher risk of progressing to acute respiratory distress syndrome (ARDS)....This trial will begin later this month at several U.S. centers."remdesivir (GS-5734) / GileadData on 53 patients treated with investigational antiviral remdesivir through the compassionate use program published in New England Journal of Medicine (Gilead Press Release) - Apr 10, 2020 - "'While the outcomes observed in this compassionate use analysis are encouraging, the data are limited,' said Merdad Parsey...'Gilead has multiple clinical trials underway for remdesivir with initial data expected in the coming weeks. Our goal is to add to the growing body of evidence as quickly as possible to more fully evaluate the potential of remdesivir and, if appropriate, support broader use of this investigational drug.'"
