COVID-19 Top News – June 8, 2020

ifenprodil (NP-120) / Algernon Pharma
Algernon receives U.S. FDA clearance for multinational phase 2b/3 human study to evaluate ifenprodil as a potential therapeutic for Covid-19 (GlobeNewswire) – Jun 4, 2020 – “Algernon Pharmaceuticals Inc….announce that it has received, on June 3rd, 2020, clearance from the U.S. FDA for its recently submitted Investigational New Drug (IND) application for its planned multinational Phase 2b/3 study of its re-purposed drug NP-120….’We have already begun the background work to start the Phase 2 trial in the U.S. and other countries as soon as possible and we will update the market shortly on our planned timelines.'”



TJM2 / I-Mab
I-MAB advances repositioned RA drug in early trial to treat Covid-19 cytokine storm (FierceBiotech) – Jun 1, 2020 – “Studies of COVID-19 patients have documented high levels of both GM-CSF and IL-6 in the bloodstream of those who become severely ill….I-MAB’s executives said during the call that if the results of part two of the TJM2 study in COVID-19 are positive, it will consult with the FDA to develop a plan to speed the drug to market. The company is also accelerating a manufacturing plan to ensure it will have enough of the drug for further clinical trials…”



AdCOVID (COVID-19 vaccine) / Altimmune, University of Alabama
Altimmune Launches Clinical Trial of T-COVID, an Investigational Intranasal Immune Modulator for the Treatment of Patients with Early COVID-19 (GlobeNewswire, Altimmune, Inc.) – Jun 1, 2020 – “Clearance of IND application received from the U.S. FDA; Planned Phase 1/2 outpatient clinical trial will focus on patients with early SARS-CoV-2 infection; Placebo-controlled trial expected to commence in June with data readout expected in Q4 2020; Therapeutic development program will complement Company’s single-dose intranasal COVID-19 vaccine candidate, AdCOVID; The planned clinical trial will evaluate the potential of T-COVID to prevent clinical worsening in patients with early COVID-19.”



astegolimab (RG 6149) / Amgen, Roche
BARDA, Genentech to accelerate phase 2 clinical trial for two investigational Covid-19 treatments (Homeland Preparedness News) – Jun 3, 2020 – “A partnership between the Biomedical Advanced Research and Development Authority (BARDA) and biotechnology company Genentech will yield a phase 2 clinical trial to evaluate two investigational drugs for the treatment of severe COVID-19 cases: anti-ST2 and IL-22-Fc. The drugs will be tested on approximately 300 patients with severe COVID-19 pneumonia that has forced them to take supplemental oxygen.”



remdesivir / Generic mfg.
Gilead announces results from phase 3 trial of remdesivir in patients with moderate Covid-19 (Gilead Press Release) – Jun 1, 2020 – P3, N=237; SIMPLE (NCT04257656); “Gilead Sciences, Inc….today announced topline results from the Phase 3 SIMPLE trial….The study demonstrated that patients in the 5-day remdesivir treatment group were 65 percent more likely to have clinical improvement at Day 11 compared with those in the standard of care group….No new safety signals were identified with remdesivir across either treatment group….Remdesivir was generally well-tolerated in both the 5-day and 10-day treatment groups.”



Lilly begins world’s first study of a potential Covid-19 antibody treatment in humans (PRNewswire) – Jun 1, 2020 – “First patients have been dosed in a Phase 1 study of LY-CoV555, the lead antibody from Lilly’s collaboration with AbCellera; The placebo-controlled study will assess safety and tolerability in patients hospitalized with COVID-19 with results anticipated by the end of June; Should Phase 1 results show the antibody can be safely administered, Lilly will initiate a Phase 2 proof of concept study to assess efficacy in vulnerable populations….The company also plans to study the drug in a preventative setting, focusing on vulnerable patient populations…”



Fauci: Moderna’s Phase 3 Covid-19 Vaccine Trial Of 30,000 Individuals Will Begin In July (Forbes) – Jun 2, 2020 – “In an interview Tuesday with the editor of JAMA, Fauci said the trial will include primarily U.S. sites, but also include international sites enrolling 30,000 individuals in a ‘randomized placebo’ controlled trial of Moderna’s vaccine against the Coronavirus strain Covid-19. Moderna’s vaccine candidate is considered in the lead among several efforts by drug and vaccine makers in the battle against the deadly virus….But Fauci confirmed Tuesday the work to begin a much larger phase 3 trial are well underway and will begin early next month.”


US has two million Covid-19 vaccine doses “ready to go” upon approval, says Trump (The Hindu Business Line) – Jun 6, 2020 – “Moderna, Novavax and Pfizer are amid the five companies shortlisted. Moderna currently seems to be in the lead. The company is planning to enter phase three testing in July, Fauci had said earlier this week according to a Forbes report.”


Experts Voice Concerns Over US Government’s Program For COVID-19 Vaccine – Jun 6, 2020 – “In a televised interview with the CNN, Dr Peter Hotez…said on June 6 that there is a lot of ‘chaos and confusion’ regarding the federal government’s program. According to the sources cited by the international media outlet, the Warp Speed program under the Trump administration has selected five companies that would most likely to manufacture the COVID-19 vaccine…dr Anthony Fauci has said that he expects at least 100,000 doses of one vaccine made by the Moderna to be available in the US by 2020.”


AstraZeneca Targeting Over 2 Billion COVID-19 Vaccine Doses After Latest Deals (Eyewire News) – Jun 5, 2020 – “The deals include a $750-million agreement with CEPI and Gavi to support the manufacturing, procurement and distribution of 300 million doses of AZD1222, with delivery to begin by year’s end. CEPI said the doses would be ‘ringfenced’ for the so-called COVID-19 Vaccine Global Access Facility, if the vaccine is found to be safe and effective. Richard Hatchett…said ‘this partnership demonstrates how the COVID-19 Vaccine Global Access Facility will bring the private, public and third sectors together to make COVID-19 vaccines available to those who need them most.'”

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