- A Southwestern hospital has reported safety data collected under the Federal Right to Try law indicating that 16 of 19 patients (84%) with COVID-19 respiratory failure treated with ZYESAMI® by Dec 31, 2021 have survived the ICU.
- No Serious Adverse Events were reported
- Patients were treated during the Omicron Surge
- Patients were treated at first onset of respiratory failure after exhausting remdesivir and other approved therapies
- Data are being included provided by NRx to FDA in support of ongoing application to FDA for Emergency Use Authorization
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.
Jack Hirschfield – Head of Corporate Communications, NRx
Managing Director – LifeSci Advisors