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NRx Pharmaceuticals Announces Positive Safety Report for ZYESAMI™ (aviptadil) in NIH Sponsored ACTIV-3 Critical Care Study in Patients with Life-Threatening COVID-19
- After Review of Approximately 140 patients in ACTIV-3 Critical Care Study, No New Safety Concerns Raised by Independent Data Safety Monitoring Board, Study
About this update from Nrx Pharmaceuticals, Inc.
[{"type":"text","content":"- After Review of Approximately 140 patients in ACTIV-3 Critical Care Study, No New Safety Concerns Raised by Independent Data Safety Monitoring Board, Study to Continue Enrollment to Target More than 600 Patients\n - ACTIV-3 Critical Care is a Public-Private Partnership Sponsored by the US National Institutes of Health to Treat COVID-19\n - ACTIV-3 Critical Care is Evaluating ZYESAMI™ and Remdesivir, in Critical COVID-19 Patients, as Monotherapy and in Combination Against Placebo\n\n\nRADNOR, Pa., Aug. 18, 2021 /PRNewswire/ -- NRx Pharmaceuticals (NRx) (NASDAQ: NRXP), a clinical stage, biopharmaceutical company today provided a safety update on ZYESAMI™ (aviptadil) which is being tested in the ACTIV-3 Critical Care Phase 3 study sponsored by the National Institutes of Health. The study's Data Safety Monitoring Board found no new safety concerns in the trial and recommended continued enrollment.\n\n \n \n \n \n \n \n\n \nAfter Review of Approximately 140 patients, No New Safety Concerns Raised by Independent Data Safety Monitoring BoardACTIV-3 is a randomized, blinded, placebo-controlled clinical trial testing ZYESAMI™ and the antiviral remdesivir (Veklury) in hospitalized patients with acute respiratory failure due to COVID-19 who require high-flow supplemental oxygen, delivered by nasal cannula, mechanical ventilation, or extracorporeal membrane oxygenation. \nStudy investigators are randomizing patients to receive one of four treatment regimens in addition to standard of care: both ZYESAMI™ and remdesivir, ZYESAMI™ and a placebo, remdesivir and placebo, or only placebo. ZYESAMI™ is administered as a daily 12 hour intravenous infusion over three days. Those randomized to receive remdesivir will receive it for up to 10 days via intravenous infusion.\nZYESAMI™ (aviptadil) is a proprietary, synthetic version of Vasoactive Intestinal Peptide or VIP, which is made naturally in the human body and appears to have lung-protective, anti-viral and anti-inflammatory effects.\nACTIV-3 represents one of three ongoing studies of ZYESAMI™ in Severe or Critical COVID-19.\nAbout NRx PharmaceuticalsNRx Pharmaceuticals (NRx) draws upon more than 300 years of collective, scientific and drug-development experience to bring improved health to patients. Its investigational product, ZYESAMI™ (aviptadil) for patients with COVID-19, has been granted Fa...