NRx Pharmaceuticals Presents Evidence ZYESAMI™ (aviptadil) Helps Prevent "Cytokine Storm" in Patients with COVID-19

Rhea-AI Summary

NRx Pharmaceuticals (Nasdaq: NRXP) will present findings on ZYESAMI™ (aviptadil) at the Disease Control and Prevention Summit on July 21, 2021. The results from a phase 2b/3 trial demonstrate ZYESAMI™ significantly prevents cytokine storms, which are linked to COVID-19 mortality. In contrast to placebo, patients treated with ZYESAMI™ showed a minimal rise in interleukin 6 levels and a significant drop in 60-day mortality rates. The company is seeking Emergency Use Authorization from the FDA based on these findings.

Positive

• Data show ZYESAMI™ significantly prevents cytokine storms in COVID-19 patients.
• A minimal increase in IL-6 levels noted in patients treated with ZYESAMI™ compared to placebo.
• ZYESAMI™ linked to a significant reduction in 60-day mortality.

Negative

• None.

RADNOR, Pa., July 19, 2021 /PRNewswire/ -- NRx Pharmaceuticals (Nasdaq: NRXP), will present data at the Disease Control and Prevention Summit on July 21, 2021 at 10:10 EST, via the following link: https://www.terrapinn.com/template/live/landing/a0A4G00001ZmpzpUAB/10433?utm_source=&utm_medium=landing-page&utm_campaign=-referral&utm_term=referral-marketing&utm_content=PA03744357

NRx Pharmaceuticals Presents Evidence ZYESAMI™ (aviptadil) Helps Prevent "Cytokine Storm" in Patients with COVID-19

The presentation identifies a statistically significant effect of ZYESAMI™ (aviptadil) in preventing the sharp rise in cytokines, commonly associated with mortality in patients with COVID-19. In the recently-completed phase 2b/3 trial, patients treated with placebo experienced a statistically significant elevation in interleukin 6 (IL-6) cytokine levels, whereas those treated with ZYESAMI™ had a minimal increase in IL-6. Change in cytokine level was a prespecified endpoint of the study.

Health regulators continue to prioritize therapies for COVID-19 which help block the impact of IL-6 cytokines in patients with COVID-19. The anti-cytokine effect of ZYESAMI™ was additionally associated with a significant decrease in 60-day mortality.

The cytokine data were collected as part of the phase 2b/3 trial of ZYESAMI™ (aviptadil) compared to placebo, in critically ill patients with COVID-19 respiratory failure. The effect was noted across a diverse set of patients, suffering different levels of COVID-19 severity and treated in both tertiary care and community hospitals.

NRx has submitted these findings to the US Food and Drug Administration (FDA) as a supplement to its pending application for Emergency Use Authorization, (EUA) and is submitting a biomarker letter of intent to the FDA as part of its biomarker program, authorized under the 21^st Century Cures Act.

"At a time when hospital admissions for COVID are rising worldwide, these placebo-controlled biomarker data suggest that aviptadil may play a critical role in preventing the sudden elevation of cytokines that is associated with mortality," said Prof Jonathan Javitt, MD, MPH, Chairman and CEO of NRx. "This linkage between the clinical effect of aviptadil on survival and recovery and a measurable biologic change in cytokine levels provides a basis for seeking a biomarker-based regulatory path as envisioned by the 21^st Century Cures Act. The lethal impact of "cytokine storm" is associated with mortality in a variety of lethal conditions including Acute Respiratory Distress Syndrome, a common cause of death in sepsis, and amniotic fluid embolus, a primary cause of maternal death during pregnancy."

NRx continues to respond to FDA information requests for additional data in support of the currently pending EUA application for ZYESAMI™ in treating critically-ill patients with COVID-19.

About NRx Pharmaceuticals

NRx Pharmaceuticals (www.nrxpharma.com) 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, a 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.

NRx is led by executives who have held senior roles at Allergan, J&J, Lilly, Novartis, Pfizer, and the US FDA. The NRx board includes Dr. Sherry Glied, former US Assistant Secretary for Health, Daniel E. Troy, former Chief Counsel of the US FDA, Chaim Hurvitz, former director of Teva and President of the Teva International Group, and General HR McMaster, PhD (US Army, Ret.) the 26^th United States National Security Advisor. NRx is publicly traded on the Nasdaq Global Select Exchange under the stock ticker NRXP.

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
617-429-3548
jmullaly@lifesciadvisors.com   

 

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SOURCE NRx Pharmaceuticals

FAQ

What did NRx Pharmaceuticals present at the Disease Control and Prevention Summit?

NRx Pharmaceuticals presented data showing ZYESAMI™ (aviptadil) helps prevent cytokine storms in COVID-19 patients.

When will NRx Pharmaceuticals present its findings?

NRx Pharmaceuticals will present its findings on July 21, 2021, at 10:10 EST.

What are the results of the phase 2b/3 trial of ZYESAMI™?

The trial indicated that ZYESAMI™ significantly prevents the rise of IL-6 cytokines and reduces 60-day mortality in COVID-19 patients.

Has NRx Pharmaceuticals submitted data to the FDA?

Yes, NRx has submitted findings to the FDA as part of its application for Emergency Use Authorization for ZYESAMI™.

What is the significance of cytokine levels in COVID-19 treatment?

Elevated cytokine levels in COVID-19 can lead to severe complications, including increased mortality; hence, managing these levels is crucial.