NRx Pharmaceuticals Announces Positive Safety Report for ZYESAMI™ (aviptadil) in NIH Sponsored ACTIV-3 Critical Care Study in Patients with Life-Threatening COVID-19

Rhea-AI Summary

NRx Pharmaceuticals (NRXP) announced a safety update for ZYESAMI™ (aviptadil), confirming no new safety concerns during the NIH-sponsored ACTIV-3 Critical Care Phase 3 study. The Data Safety Monitoring Board reviewed data from approximately 140 patients and recommended continued enrollment. ZYESAMI™ is being tested alongside remdesivir in hospitalized COVID-19 patients requiring high-flow oxygen. This study is one of three ongoing trials for ZYESAMI™ in critical COVID-19 cases. NRx holds FDA Fast Track designation and Breakthrough Therapy Designation for ZYESAMI™.

Positive

• No new safety concerns reported for ZYESAMI™ in the ACTIV-3 study.
• Continued enrollment recommended by the Data Safety Monitoring Board.
• ZYESAMI™ has been granted Fast Track and Breakthrough Therapy Designation by the FDA.

Negative

• None.

RADNOR, Pa., Aug. 18, 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-3 Critical Care Phase 3 study sponsored by the National Institutes of Health. The study's Data Safety Monitoring Board found no new safety concerns in the trial and recommended continued enrollment.

After Review of Approximately 140 patients, No New Safety Concerns Raised by Independent Data Safety Monitoring Board

ACTIV-3 is a randomized, blinded, placebo-controlled clinical trial testing ZYESAMI™ and the antiviral remdesivir (Veklury) 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. 

Study investigators are randomizing patients to receive one of four treatment regimens in addition to standard of care: both ZYESAMI™ and remdesivir, ZYESAMI™ and a placebo, remdesivir and placebo, or only placebo. ZYESAMI™ is administered as a daily 12 hour intravenous infusion over three days. Those randomized to receive remdesivir will receive it for up to 10 days via intravenous infusion.

ZYESAMI™ (aviptadil) is a proprietary, synthetic version of Vasoactive Intestinal Peptide or VIP, which is made naturally in the human body and appears to have lung-protective, anti-viral and anti-inflammatory effects.

ACTIV-3 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-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 Institutes of Health, the Biomedical Advanced Research and Development Authority part of the US Department of Health and Human Services, and the Medical Countermeasures program, part of the US Department of Defense. The FDA has additionally granted Breakthrough Therapy Designation, a Special Protocol Agreement, and a Biomarker Letter of Support to NRx for NRX-101, an investigational medicine to treat suicidal bipolar depression. NRX-101 is currently in Phase 3 trials, with readouts expected in 2022. In July 2021, the Government of Israel awarded NRx the exclusive worldwide right to develop and market the BriLife™ COVID vaccine developed by the Israel Institute for Biological Research.

NRx is led by executives who have held senior roles at Allergan, J&J, Lilly, Novartis, Pfizer, and the US FDA. NRx is chaired by Prof Jonathan Javitt, MD, MPH, who has held leadership roles in six biotechnology startup companies with public exits and been appointed to advisory roles in four US Presidential Administrations. The NRx board includes Dr. Sherry Glied, former US Assistant Secretary for Health (ASPE), Daniel E. Troy, JD, former Chief Counsel of the US FDA, Chaim Hurvitz, former director of Teva and President of the Teva International Group, and General H.R. McMaster, Ph.D. (US Army, Ret.) the 26th United States National Security Advisor.

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

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

CORPORATE CONTACT: 
Jack Hirschfield
Head of External Affairs, NRx 
jhirschfield@nrxpharma.com  
512-674-5163                                                 

INVESTOR RELATIONS
John Mullaly
LifeSci Advisors
jmullaly@lifesciadvisors.com 
617-429-3548

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SOURCE NRx Pharmaceuticals

FAQ

What are the latest updates from NRx Pharmaceuticals regarding ZYESAMI™?

NRx Pharmaceuticals confirmed no new safety concerns for ZYESAMI™ in the NIH-sponsored ACTIV-3 study and recommended continued enrollment.

What is the purpose of the ACTIV-3 Critical Care study?

The ACTIV-3 study is testing the efficacy of ZYESAMI™ alongside remdesivir for COVID-19 patients requiring high-flow oxygen.

How many patients were reviewed in the NRx safety report for ZYESAMI™?

The Data Safety Monitoring Board reviewed data from approximately 140 patients in the ACTIV-3 study.

What designations has ZYESAMI™ received from the FDA?

ZYESAMI™ has received Fast Track designation and Breakthrough Therapy Designation from the FDA.