© 2021 MJH Life Science and Pharmacy Times. all rights reserved.

© 2021 MJH Life Sciences™ and Pharmacy Times. all rights reserved.

NRx Pharmaceuticals announced that the independent data security monitoring committee has found no new problems, and the committee recommends to continue to register.

The clinical-stage biopharmaceutical company NRx Pharmaceuticals has announced a favorable safety update for aviptadil (Zyesami), which is being tested in the ACTIV-3b Intensive Care Phase 3 study sponsored by the National Institutes of Health (NIH).

In the third analysis, the independent data security monitoring committee of the study found no new security issues after reviewing a total of 348 people, and recommended that the target of 640 people should continue to be included. 1

Aviptadil is being tested as a monotherapy and in combination with remdesivir against placebos for patients with severe COVID-19.

"It is very hopeful to see an increase in the number of patients in this study, and NIH safety analysis continues to show that Zyesami is safe to administer to critically ill COVID-19 patients who have no other treatment options," said Jonathan Javitt, MD, chairman and chairman of NRx CEO MPH said in a statement. “We now have the safety data of more than 600 patients who received Zyesami treatment in the ICU or degraded ward, and there have been no reports of accidental, drug-related serious adverse events.”1

Research leaders stated that enrollment has been stable and the delta surge has not dissipated.

Most of the people registered are not vaccinated.

NIH expects to include Brazil's first patient in the study in February 2022.

ACTIV-3b is a placebo-controlled randomized clinical trial for individuals who are hospitalized with acute respiratory failure due to COVID-19 and need to provide high-flow supplemental oxygen through extracorporeal membrane oxygenation, mechanical ventilation, or nasal intubation.

This study is one of 3 ongoing studies conducted by aviptadil in severe or critical COVID-19.

In November, NRx announced that the FDA had completed a review of aviptadil's updated manufacturing information, allowing the company to distribute aviptadil produced on a commercial scale for use in clinical trials and good manufacturing practices (GMP) for other future purposes approved in future regulatory actions. 2

Before the COVID-19 pandemic, Aviptadil was never manufactured as a commercial drug for intravenous injection.

At that time, the FDA reviewed the GMP manufacturing process with batch sizes ranging from 10,000 to 100,000 and a shelf life of 150 days, and did not determine the basis for clinical shelving.

"This is the first time that aviptadil has been produced for intravenous and inhalation purposes in a commercial GMP environment inspected by the FDA, and has passed the regulatory review of production and CMC. With the help of our Nephron Pharmaceuticals partners, we have verified the FDA and other regulatory agencies The analytical techniques required to test the purity, potency and stability of our drugs are required," Javit said in a statement. 2

"We have developed a universal ingredient (aviptadil) into a modern drug that meets GMP specifications, which can be produced on a commercial scale, cost, and shelf life," he said. "While we continue to focus on demonstrating the clinical safety and effectiveness of the treatment of COVID-19, we now have an investigational drug platform reviewed by the FDA, which allows us to investigate the innumerable use of Zyesami in intravenous and inhaled forms that causes lung damage. Other fatal diseases." 2

1. NRx Pharmaceuticals announced a new and favorable safety report for Zyesami (aviptadil) in the NIH-sponsored ACTIV-3b intensive care study for life-threatening COVID-19 patients. NRx Pharmaceutical Company. Press Releases. December 14, 2021. Visited on December 14, 2021. e-mail.

2. NRx Pharmaceuticals received a review of the production information of Zyesami (aviptadil) by the US Food and Drug Administration. Press Releases. November 11, 2021. Access December 14, 2021 https://www.yahoo.com/now/nrx-pharmaceuticals-receives-us-food-125400282.html?guccounter=1&guce_referrer=aHR0cHM6Ly93d3cuZ29vZ2xlLmNvbS8&guce_referrer_sig=AQAAALzZQbk2yEvUcORviojtsrEwE8pbDTr7WsQ9y7kGToMDe8DrE7cijw4qTJzcE2mY_z7vY74IFNZh69u_8gzevt3HvsnT327J0tGwgzzcZgvhsHNOFk38HN5cpe18IfW9ds0l78epd-E806CLX2RV7Xbd9O-u4OdcpTY1rKevsFZs