NRx Receives Initial Report of Patient Safety and Survival from Right to Try use of ZYESAMI® (aviptadil) during Omicron Surge

Rhea-AI Summary

On January 26, 2022, NRx Pharmaceuticals (NRXP) announced a safety report from a Southwestern hospital regarding ZYESAMI® (Aviptadil) treatment for COVID-19 respiratory failure under the Right to Try Law. Of the first 19 patients treated by December 31, 2021, three died, while 16 (84%) were reported alive by January 22, 2021, with 14 discharged. No Serious Adverse Events linked to ZYESAMI were reported. The data will support an FDA Emergency Use Authorization application for critical COVID-19 patients. ZYESAMI is also undergoing trials in the NIH-sponsored ACTIV-3b trial.

Positive

• 84% survival rate reported among treated patients.
• No Serious Adverse Events related to ZYESAMI were noted.
• Application submitted for FDA Emergency Use Authorization for critical patients.

Negative

• Three patients died after receiving treatment.
• No control group involved in the safety report.
• Data does not confirm efficacy, as it is not part of a controlled study.

RADNOR, Pa., Jan. 26, 2022 /PRNewswire/ -- NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage, biopharmaceutical company, has received a first safety report from a Southwestern hospital where physicians have administered ZYESAMI® (Aviptadil) to patients with COVID-19 respiratory failure. These patients were treated under the Federal Right to Try Law that gives access to investigational medicines for patients who have been diagnosed with life-threatening diseases or conditions, who have tried all approved treatment options, and who are unable to participate in a clinical trial to access certain unapproved treatments.  This Right to Try use of ZYESAMI occurred during the current Omicron surge, although patients were not necessarily tested for the specific COVID variant that caused their ICU admission.

The safety update report received from the hospital indicated that of the first 19 patients treated by Dec. 31, 2021, three had died and 16 (84%) were reported to be alive by Jan. 22, 2021. At the time of the report, 14 of these 16 patients had been discharged to a rehabilitation center or home and two remained in the hospital.  No Serious Adverse Events (SAEs) related to ZYESAMI were reported.  These data were included in an application to FDA for Emergency Use Authorization for the treatment of patients with critical COVID-19 who are at immediate risk of death from respiratory failure despite treatment with approved therapy including remdesivir. NRx will continue to update the safety database collected under the Right to Try law on an ongoing basis. 

The data being received from hospitals and patients treated under the Right to Try law do not involve a control group and are not part of a research study designed to test efficacy.

ZYESAMI continues to be tested in the ongoing NIH-sponsored ACTIV-3b (TESICO) trial that has now accrued two-thirds of its targeted enrollment.

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. The Company is developing the BriLife™ Covid vaccine, developed by the Israel Institute for Biological Research, under an exclusive license from the Israel Ministry of Defense. NRx is additionally developing ZYESAMI® (aviptadil) for patients with COVID-19, and 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 (BARDA) 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.

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 US 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 Corporate Communications, NRx
jhirschfield@nrxpharma.com

INVESTOR RELATIONS
Eric Goldstein
Managing Director – LifeSci Advisors
egoldstein@lifesciadvisors.com

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SOURCE NRx Pharmaceuticals

FAQ

What were the results of NRx Pharmaceuticals' ZYESAMI treatment for COVID-19?

NRx Pharmaceuticals reported a safety update indicating an 84% survival rate among patients treated with ZYESAMI, but three patients died.

What does the safety report from NRx Pharmaceuticals involve?

The report involves 19 patients treated under the Right to Try law, with no Serious Adverse Events reported.

How does NRx Pharmaceuticals plan to use the safety data from ZYESAMI?

The safety data will support an application for FDA Emergency Use Authorization for treating critical COVID-19 patients.

Is ZYESAMI part of a clinical trial?

Yes, ZYESAMI is also being tested in the ongoing NIH-sponsored ACTIV-3b trial.

How many patients were treated with ZYESAMI under the Right to Try law?

Nineteen patients were treated with ZYESAMI under the Right to Try law.