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NRx Pharmaceuticals Announces US National Institutes of Health Study of ZYESAMI® (aviptadil) in Critical COVID-19 is Cleared to Complete Full Enrollment
- After review of more than 448 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 448 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 640 Patients\n - ZYESAMI® (aviptadil) is the sole remaining investigational medicine in ACTIV-3b with recent closures of other arms\n - ACTIV-3b Critical Care Study is evaluating ZYESAMI and Veklury® (remdesivir), in Critical COVID-19 Patients, as monotherapy and in combination against placebo\n - ACTIV-3b Trial to commence enrollment in Brazil, EU, UK, and Scandinavia in the coming months\n\n\nRADNOR, Pa., Feb. 15, 2022 /PRNewswire/ -- NRx Pharmaceuticals (Nasdaq: NRXP), a clinical-stage, biopharmaceutical company, today announced results of a review conducted by the Therapeutics and Prevention Data Safety and Monitoring Board (DSMB) of the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) on February 14, 2022. The DSMB reviewed data on 448 ICU patients with Critical COVID-19 Respiratory Failure who were enrolled in the ACTIV-3b (TESICO) trial1. The TESICO protocol was submitted by NIH and cleared by the US Food and Drug Administration (FDA) as a Phase 3 trial that, if positive, may be used in the submission of a New Drug Application for ZYESAMI®. \n\n \n \n \n \n \n \n\n \nACTIV-3b is a randomized, placebo-controlled clinical trial testing ZYESAMI and Veklury® (remdesivir; Gilead Sciences: Nasdaq:GILD) — alone and in combination — in hospitalized patients with acute respiratory failure due to COVID-19. The patients enrolled in TESICO are critically-ill patients in the ICU who have exhausted other approved therapies and require high-flow nasal oxygen, mechanical ventilation, or extracorporeal membrane oxygenation to maintain blood oxygen. \nAt a September 2021 Reagan Udall Foundation conference chaired by Dr. Francis Collins, former Director of the NIH and Dr. Janet Woodcock, Acting Commissioner of the FDA, Dr. Collins identified ZYESAMI® as one of a handful of investigational compounds selected by the NIH for Phase 3 study from among 600 candidate compounds initially considered.2 Last week, the NIH announced the discontinuation of the PF-07304814 arm of the ACTIV-3 trial on account of futility3 According to an NIH spokesperson, aviptadil is the sole remaining investigational...