NRx Pharmaceuticals Announces New, Favorable Safety Report for ZYESAMI® (aviptadil) in NIH Sponsored ACTIV-3b Critical Care Study in Patients with Life-Threatening COVID-19

Rhea-AI Summary

NRx Pharmaceuticals announced that the Independent Data Safety Monitoring Board found no new safety concerns in the ongoing ACTIV-3b Critical Care Study evaluating ZYESAMI® (aviptadil) for COVID-19 patients. 348 patients have been reviewed, and enrollment will continue toward a target of 640 patients. The NIH expects the first patient from Brazil to be included by February 2022. The study is pivotal in assessing ZYESAMI's safety and effectiveness alongside remdesivir, and it reflects NRx's commitment to treating critical COVID-19 cases.

Positive

• No new safety concerns identified in 348 enrolled patients in the ACTIV-3b study.
• Study cleared to continue enrollment aiming for 640 patients.
• First patient in Brazil expected to join the trial in February 2022.
• ZYESAMI shows safety in over 600 patients with no unexpected serious adverse events.

Negative

• None.

• After Review of More than 348 Enrolled Patients in ACTIV-3b Critical Care Study, No New Safety Concerns Identified by Independent Data Safety Monitoring Board; Study Cleared to Continue Enrollment to Target 640 Patients

• First Patient in Brazil Expected to be Included in US National Institutes of Health (NIH) Trial in February 2022

• ACTIV-3b Critical Care Study is Evaluating ZYESAMI^® (aviptadil) and Remdesivir, in Critical COVID-19 Patients, as Monotherapy and in Combination Against Placebo
  
• ACTIV-3b Critical Care is a Public-Private Partnership Sponsored by the NIH to Treat COVID-19
  

RADNOR, Pa., Dec. 14, 2021 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals (Nasdaq: NRXP), a clinical-stage, biopharmaceutical company, today provided a new safety update on ZYESAMI^® (aviptadil), which is being tested in the ACTIV-3b Critical Care Phase 3 study sponsored by the US National Institutes of Health (NIH). In its third scheduled analysis, the study’s Independent Data Safety Monitoring Board found no new safety concerns after reviewing a total of 348 patients and recommended continued enrollment.

The study leadership indicated that enrollment has been steady, and the Delta surge does not seem to be dissipating. The majority of enrolled patients are unvaccinated. The NIH expects to include the first patient in Brazil in the study in February 2022.

“It is promising to see the number of patients in this study increase while the safety analysis by the NIH continues to show ZYESAMI is safe to administer to patients with Critical COVID-19, who have no other therapeutic alternative,” said Prof. Jonathan Javitt, MD, MPH, Chairman and CEO of NRx. “We now have safety data on more than 600 patients treated with ZYESAMI in the ICU or step-down unit, with no reports of unexpected, drug-related, serious adverse events.”

ACTIV-3b is a randomized, placebo-controlled clinical trial testing ZYESAMI and remdesivir (Veklury) — alone and in combination — 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.

ACTIV-3b 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. 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 continues to develop ZYESAMI^® (aviptadil) for patients with COVID-19, which 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 medical technology 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.

MEDIA CONTACT:
Jack Hirschfield
Head of Corporate Communications, NRx
jhirschfield@nrxpharma.com
512-674-5163

INVESTOR RELATIONS:
Eric Goldstein
LifeSci Advisors
egoldstein@lifesciadvisors.com
646-791-9729

FAQ

What were the results of the latest ACTIV-3b study update for NRXP?

The latest update indicated no new safety concerns after reviewing 348 patients, allowing the study to continue with the goal of enrolling 640 patients.

When is the first patient expected to join the ACTIV-3b study from Brazil?

The first patient from Brazil is expected to be included in the study in February 2022.

What is ZYESAMI being tested for in the ACTIV-3b study?

ZYESAMI is being evaluated for its safety and effectiveness in treating critical COVID-19 patients alongside remdesivir.

What is the significance of the ACTIV-3b study for NRXP investors?

The study's continued enrollment and safety findings suggest ongoing progress in developing ZYESAMI, which may positively influence investor confidence.

How many patients have been treated with ZYESAMI in critical care settings?

Over 600 patients have been treated with ZYESAMI in ICU or step-down units without reports of unexpected serious adverse events.