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NRx Pharmaceuticals Announces New Finding from ZYESAMI™ (aviptadil) Phase 2b/3 Clinical Trial Demonstrating Clinically Significant Relief from Respiratory Distress in Critical COVID-19
- NRx Has Provided Updated Data to US Food and Drug Administration (FDA) in Support of Emergency Use Authorization Request for ZYESAMI™ (aviptadil) - NRx to
About this update from Nrx Pharmaceuticals, Inc.
[{"type":"text","content":"- NRx Has Provided Updated Data to US Food and Drug Administration (FDA) in Support of Emergency Use Authorization Request for ZYESAMI™ (aviptadil)\n - NRx to Submit Breakthrough Therapy Designation to FDA for ZYESAMI™ for the Treatment of Respiratory Failure in Patients with Critical COVID-19\n\n\nRADNOR, Pa., Aug. 30, 2021 /PRNewswire/ -- NRx Pharmaceuticals (NRx) (Nasdaq: NRXP) announced an additional finding in its phase 2b/3 clinical trial investigating ZYESAMI™ (aviptadil) for the treatment of patients with acute Respiratory Failure due to Critical COVID-19. Previously announced results have focused on survival and recovery from respiratory failure at 60 days, and ZYESAMI's apparent role in preventing rise in the inflammatory cytokine IL-6, known as \"Cytokine Storm.\"\n\n \n \n \n \n \n \n\n \nNRx Pharmaceuticals Announces New Finding from ZYESAMI™ (aviptadil) Phase 2b/3 Clinical TrialNRx's new analysis shows that patients treated with ZYESAMI demonstrated improvement in blood oxygen, indicative of improved lung function, within a day of starting treatment. The average difference in Respiratory Distress Ratio between those treated with aviptadil and placebo was both clinically meaningful and statistically significant. Moreover, the difference is comparable to that reported a year ago from an open label study at Houston Methodist Hospital by Dr. J Georges Yousef. \n\"With the conclusion of the analysis of primary and secondary endpoints, we are able to focus on prespecified endpoints that confirm mechanism of action,\" said Prof Jonathan Javitt, MD, MPH, Chairman and CEO of NRx. \"COVID-19 attacks the cells that line the lung in a manner that prevents them from transmitting oxygen to the body. It is this respiratory failure that starts the lethal process of COVID,\" This latest analysis provides confirmatory evidence that aviptadil improves the lung's ability to transmit oxygen within a day of initiating treatment. The benefit was seen across all patients, all baseline severities, and all types of hospitals. We believe this new finding illustrates ZYESAMI's mechanism of action in a placebo-controlled trial and supports our application for Breakthrough Therapy Designation to the FDA.\"\nPrior data regarding reduced respiratory distress were reported by Dr. J. Georges Youssef, Head of Academic Pulmonary Medicine at Houston M...