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 reviewing 232 patients enrolled in the ACTIV-3b intensive care study, no new safety concerns were raised by the Independent Data Safety Oversight Committee

– The ACTIV-3b Critical Care study evaluates ZYESAMI â„¢ and Remdesivir, in COVID-19 critical patients, as monotherapy and in combination against a placebo

– The study is authorized to continue recruiting to target more than 600 patients

– ACTIV-3b Critical Care is a public-private partnership sponsored by the United States National Institutes of Health to treat COVID-19

RADNOR, Pennsylvania., September 29, 2021 / PRNewswire / – NRx Pharmaceuticals (NRx) (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, today provided a safety update on ZYESAMI â„¢ (aviptadil) being tested in the ACTIV study -3b Critical Care Phase 3 sponsored by the National Institutes of Health. In its second scheduled review, the study’s independent data safety oversight committee found no new safety issues, after reviewing a total of 231 patients, and recommended further recruitment.

(PRNewsfoto / NeuroRx)

After reviewing 232 patients enrolled in the ACTIV-3b critical care study, no new safety concerns were raised by the Independent Data Safety Oversight Committee

“With this second independent safety review in the ACTIV-3b trial, the safety database for ZYESAMI has grown to over 500 patients through our various clinical trials and expanded access programs. serious adverse events,“said Pr. Jonathan javitt, MD, MPH, Chairman and CEO of NRx.

ACTIV-3b is a randomized, placebo-controlled trial testing ZYESAMI â„¢ and remdesivir (Veklury) – alone and in combination – in hospitalized patients with acute respiratory failure due to COVID-19 who require supplemental high flow oxygen delivered by a nasal cannula, mechanical ventilation or extracorporeal membrane oxygenation.

ACTIV-3b represents one of three ongoing studies of ZYESAMI â„¢ in severe or critical COVID-19.

About NRx Pharmaceuticals

NRx Pharmaceuticals (NRx) draws on more than 300 years of collective, scientific and drug development experience to improve patient health. Its investigational product, ZYESAMI â„¢ (aviptadil) for patients with COVID-19, has received Fast Track designation from the United States Food and Drug Administration (FDA) and is currently in phase 3 funded trials. by the United States National Institutes of Health, the Biomedical Advanced Research and Development Authority which is part of the United States Department of Health and Human Services, and the Medical Countermeasures Program, which is part of the United States Department of Defense . The FDA has further granted a breakthrough therapy designation, a special protocol agreement, and a letter of biomarker support to NRx for NRX-101, an investigational drug to treat suicidal bipolar depression. NRX-101 is currently in Phase 3 trials, with readings expected in 2022. In July 2021, the government of Israel granted NRx the exclusive worldwide right to develop and market the BriLife â„¢ COVID vaccine developed by the Israel Biological Research Institute.

NRx is led by executives who have held leadership positions at Allergan, J&J, Lilly, Novartis, Pfizer and the US FDA. NRx is chaired by Prof Jonathan javitt, MD, MPH, who has held leadership positions in six biotech start-ups with public outings and has been appointed to advisory roles in four US presidential administrations. The NRx card includes Dr. Sherry slips, former US Assistant Secretary of Health (ASPE), Daniel E. Troy, JD, former US FDA legal counsel, Chaim Hurvitz, former director of Teva and chairman of Teva International Group, and general RH McMaster, Ph.D. (US Army, Ret.) The 26th United States National Security Advisor.

Caution Regarding Forward-Looking Statements
This announcement by NRx Pharmaceuticals, Inc. includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995, which may include, but are not limited to, statements regarding our outlook, product development, business outlook and market and industry trends and conditions, as well as company strategies, plans, objectives and goals. These forward-looking statements are based on current beliefs, expectations, estimates, forecasts and projections, as well as on assumptions made by the management of the company and on information currently available to it.

The company assumes no obligation to revise any forward-looking statement, whether as a result of new information, future events or otherwise. Therefore, you should not rely on any forward-looking statements, and all forward-looking statements are qualified herein by reference to the cautionary statements set forth above.

Jack Hirschfield
Head of External Affairs, NRx

John mullaly
LifeSci Advisors



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SOURCE NRx Pharmaceuticals



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