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NRx Pharmaceuticals Announces New, Favorable Safety Report for ZYESAMI® (aviptadil) in NIH Sponsored ACTIV-3b Critical Care Study in Patients with Life-Threatening COVID-19
After Review of More than 348 Enrolled Patients in ACTIV-3b Critical Care Study, No New Safety Concerns Identified by Independent Data Safety Monitoring
About this update from Nrx Pharmaceuticals, Inc.
[{"type":"text","content":"After Review of More than 348 Enrolled Patients in ACTIV-3b Critical Care Study, No New Safety Concerns Identified by Independent Data Safety Monitoring Board; Study Cleared to Continue Enrollment to Target 640 Patients First Patient in Brazil Expected to be Included in US National Institutes of Health (NIH) Trial in February 2022 ACTIV-3b Critical Care Study is Evaluating ZYESAMI® (aviptadil) and Remdesivir, in Critical COVID-19 Patients, as Monotherapy and in Combination Against PlaceboACTIV-3b Critical Care is a Public-Private Partnership Sponsored by the NIH to Treat COVID-19 RADNOR, Pa., Dec. 14, 2021 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals (Nasdaq: NRXP), a clinical-stage, biopharmaceutical company, today provided a new safety update on ZYESAMI® (aviptadil), which is being tested in the ACTIV-3b Critical Care Phase 3 study sponsored by the US National Institutes of Health (NIH). In its third scheduled analysis, the study’s Independent Data Safety Monitoring Board found no new safety concerns after reviewing a total of 348 patients and recommended continued enrollment. The study leadership indicated that enrollment has been steady, and the Delta surge does not seem to be dissipating. The majority of enrolled patients are unvaccinated. The NIH expects to include the first patient in Brazil in the study in February 2022. “It is promising to see the number of patients in this study increase while the safety analysis by the NIH continues to show ZYESAMI is safe to administer to patients with Critical COVID-19, who have no other therapeutic alternative,” said Prof. Jonathan Javitt, MD, MPH, Chairman and CEO of NRx. “We now have safety data on more than 600 patients treated with ZYESAMI in the ICU or step-down unit, with no reports of unexpected, drug-related, serious adverse events.” ACTIV-3b is a randomized, placebo-controlled clinical 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.ACTIV-3b represents one of three ongoing studies of ZYESAMI in Severe or Critical COVID-19. About NRx Pharmaceuticals NRx Pharmaceuticals (NRx) draws upon more than 300 years of collective, scientific, and drug-developme...