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NRx Pharmaceuticals Announces Second Favorable Safety Report for ZYESAMI™ (aviptadil) in NIH Sponsored ACTIV-3b Critical Care Study in Patients with Life-Threatening COVID-19
- After Review of 232 Enrolled Patients in ACTIV-3b Critical Care Study, No New Safety Concerns Raised by Independent Data Safety Monitoring Board - ACTIV-3b
About this update from Nrx Pharmaceuticals, Inc.
[{"type":"text","content":"- After Review of 232 Enrolled Patients in ACTIV-3b Critical Care Study, No New Safety Concerns Raised by Independent Data Safety Monitoring Board\n - ACTIV-3b Critical Care Study is Evaluating ZYESAMI™ and Remdesivir, in Critical COVID-19 Patients, as Monotherapy and in Combination Against Placebo\n - Study Cleared to Continue Enrollment to Target More than 600 Patients\n - ACTIV-3b Critical Care is a Public-Private Partnership Sponsored by the US National Institutes of Health to Treat COVID-19\n\n\nRADNOR, Pa., Sept. 29, 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-3b Critical Care Phase 3 study sponsored by the National Institutes of Health. In its second scheduled analysis, the study's Independent Data Safety Monitoring Board found no new safety concerns, after reviewing a total of 231 patients, and recommended continued enrollment.\n\n \n \n \n \n \n \n\n \nAfter Review of 232 Enrolled Patients in ACTIV-3b Critical Care Study, No New Safety Concerns Raised by Independent Data Safety Monitoring Board\"With this second independent safety analysis in the ACTIV-3b trial, the safety database on ZYESAMI has grown to more than 500 patients across our various clinical trials and expanded access programs. So far, there have been no reports of unexpected, drug-related serious adverse events,\" said Prof. Jonathan Javitt, MD, MPH, Chairman and CEO of NRx.\nACTIV-3b is a randomized, placebo-controlled trial testing ZYESAMI™ and remdesivir (Veklury) -- alone and in combination -- 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. \nACTIV-3b represents one of three ongoing studies of ZYESAMI™ in Severe or Critical COVID-19.\nAbout NRx Pharmaceuticals\nNRx 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 Fast Track designation by the US Food and Drug Administration (FDA) and is currently undergoing phase 3 trials funded by the US National Institu...