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Alinia (nitazoxanide) / Lupin, Romark LabRomark initiates phase 3 clinical trials of NT-300 for Covid-19 (PRNewswire) - Apr 27, 2020 - "Romark announced today it will initiate two clinical trials of its investigational new drug candidate NT-300 (nitazoxanide extended-release tablets) for prevention of COVID-19....The first trial is designed to enroll 800 elderly residents of long-term care facilities following reports of the first case of COVID-19 at the sites. The second will enroll 800 healthcare workers who are at risk of exposure to the SARS-CoV-2 coronavirus....In addition to these prevention studies, Romark plans to conduct a third clinical trial of NT-300 for the early treatment of COVID-19 and other viral respiratory illnesses."remdesivir (GS-5734) / GileadGilead announces results from phase 3 trial of investigational antiviral remdesivir in patients with severe Covid-19 (Gilead Press Release) - Apr 29, 2020 - P3, N=237; SIMPLE (NCT04257656); Sponsor: Capital Medical University; "Gilead Sciences, Inc....today announced topline results....The study demonstrated that patients receiving a 10-day treatment course of remdesivir achieved similar improvement in clinical status compared with those taking a 5-day treatment course....No new safety signals were identified with remdesivir across either treatment group....Outside of Italy, the overall mortality rate at Day 14 was 7 percent (n=23/320) across both treatment groups, with 64 percent (n=205/320) of patients experiencing clinical improvement at Day 14 and 61 percent (n=196/320) of patients discharged from the hospital....A second SIMPLE trial....The results from the first 600 patients of this study are expected at the end of May."dociparstat sodium (CX-01) / ChimerixChimerix Announces Initiation of a Phase 2/3 Study of DSTAT in Acute Lung Injury for Patients with Severe COVID-19 (GlobeNewswire, Chimerix, Inc.) - Apr 29, 2020 - "FDA Clearance to Proceed with Phase 2/3 Randomized, Double-Blind, Placebo Controlled Study....Chimerix...today announced the Company’s initiation of a Phase 2/3 study of dociparstat sodium (DSTAT) in COVID-19 patients with acute lung injury (ALI)....The study is a 1:1 randomized, double-blind, placebo-controlled, Phase 2/3 trial to determine the safety and efficacy of DSTAT in adults with severe COVID-19 who are at high risk of respiratory failure....The Phase 2 portion of the study will enroll 24 subjects to confirm the maximum safe dose and will then expand by an additional 50 patients (74 total) at the selected dose....Contingent upon positive results, the Phase 3 portion of the study will enroll approximately 45."CAP-1002 / CapricorNew Capricor Data Reports 100 Percent Survival in Critical COVID-19 Patients Treated with CAP-1002 (GlobeNewswire, Capricor Therapeutics) - Apr 29, 2020 - "Capricor Therapeutics...announced today new data reporting 100 percent survival in critical COVID-19 patients who were treated with Capricor’s lead asset...at Cedars-Sinai Medical Center as part of six compassionate care cases. Over the course of one month, six critically ill COVID-19 patients...were safely treated with CAP-1002. Of the six patients treated, four of them have been discharged. Following a review of the available data, the U.S. Food and Drug Administration (FDA) approved the Company’s expanded access protocol to treat up to 20 additional COVID-19 patients. There is also a randomized, placebo-controlled trial planned to treat patients..."trabedersen (OT-101) / Autotelic, Mateon TherapeuticsMateon Announces the Filing of an IND with US FDA to Evaluate its Antisense Drug Candidate OT-101 in COVID-19 patients (GlobeNewswire, Mateon Therapeutics) - Apr 27, 2020 - "Mateon Therapeutics Inc....announced today it has submitted an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) to study its investigational drug, OT-101, for the treatment of COVID-19 pandemic. The proposed randomized, double-blind, placebo-controlled Phase 2 study is intended to evaluate the safety and efficacy of OT-101 in adult patients hospitalized with COVID-19 and pneumonia in the US....'We look forward to collaborating closely with leading clinical investigators and the FDA to validate the effectiveness of OT-101 in treating COVID-19 in a controlled clinical setting.'"Kevzara (sarilumab) / Asahi Kasei, Regeneron, SanofiSanofi and Regeneron provide update on U.S. Phase 2/3 adaptive-designed trial in hospitalized COVID-19 patients (GlobeNewswire, Sanofi) - Apr 27, 2020 - "Sanofi and Regeneron Pharmaceuticals, Inc....today announced the preliminary results from the Phase 2 portion of an ongoing Phase 2/3 trial evaluating Kevzara® (sarilumab), an interleukin-6 (IL-6) receptor antibody, in hospitalized patients with “severe” or “critical” respiratory illness caused by COVID-19. Following a review by the Independent Data Monitoring Committee (IDMC) of all available Phase 2 and Phase 3 data, the trial will be immediately amended so that only 'critical' patients continue to be enrolled to receive Kevzara 400 mg or placebo....Preliminary analysis of the Phase 2 portion of the trial demonstrated that Kevzara rapidly lowered C-reactive protein, a key marker of inflammation, meeting the primary endpoint..."mRNA-1273 / Moderna TherapeuticsModerna announces IND submitted to U.S. FDA for phase 2 study of mRNA vaccine (mRNA-1273) against novel coronavirus (Businesswire) - Apr 28, 2020 - "Moderna, Inc....today announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for the company’s mRNA vaccine candidate (mRNA-1273) against the novel coronavirus (SARS-CoV-2)....Moderna has received initial feedback from the FDA on the design of the planned Phase 2 study, which is expected to begin in the second quarter of 2020. This study will evaluate the safety, reactogenicity and immunogenicity of two vaccinations of mRNA-1273 given 28 days apart."ChAdOx1 nCoV-19 / Jenner Institute, University of Oxford, Vaccitech, Oxford BiomedicaIndia's Serum Institute gears up to make millions of doses of potential Covid-19 vaccine (News-Medical) - Apr 28, 2020 - "The Serum Institute of India plans to start manufacturing Oxford University's Covid-19 vaccine in 3 weeks to get a head start on production, the company announced....Serum Institute of India is now collaborating with Codagenix...for a live attenuated vaccine candidate. The vaccine is in the preclinical stage, being tested on mice and primates. The project is estimated to cost around $41.9 million and to be in the market by early 2022....Animal trials on mice and primates are in the planning stage, and human trials should begin in September if all goes well....The vaccine will sell at around Rs. 1000 in India, he says, enough to cover the firm's production costs."Merck and Institute for Systems Biology collaborate to define molecular mechanisms of SARS-CoV-2 infection and identify potential prognostic biomarkers (Businesswire) - Apr 27, 2020 - "Merck...and the Institute for Systems Biology (ISB), today announced a new research collaboration to investigate and define the molecular mechanisms of SARS-CoV-2 infection and COVID-19 and identify targets for medicines and vaccines. Merck has also entered into an agreement with the Biomedical Advanced Research and Development Authority (BARDA)...for BARDA to provide funding support for this research....'This collaboration with Merck provides critical support for the recently launched scientific trial being co-led by ISB and Swedish Medical Center, both part of the Providence St. Joseph Health network.'"COVID-19 S-Trimer vaccine / Sichuan Clover BiopharmaCEPI announces COVID-19 vaccine development partnership with Clover Biopharmaceuticals’ Australian subsidiary (Businesswire) - Apr 27, 2020 - "Richard Hatchett...said: 'We are delighted to partner with Clover Australia on their innovative COVID-19 S-Trimer vaccine candidate. They produced their vaccine within a month of the virus sequence becoming available, and they have rapidly advanced toward a first in human trial.'"
