Safety Report on Zyesami to Treat Critical COVID-19 Is Favorable
NRx Pharmaceuticals announces that no new concerns were identified by an independent data safety monitoring board, which recommends continued enrollment.
NRx Pharmaceuticals, a clinical-stage, biopharmaceutical company, has announced a favorable safety update on aviptadil (Zyesami), which is being tested in the ACTIV-3b Critical Care phase 3 study, sponsored by the US National Institutes of Health (NIH).
In the third analysis, the study’s independent data safety monitoring board found no new safety concerns after reviewing a total of 348 individuals, and it recommended continued enrollment to the target of 640 individuals.1
Aviptadil is being tested to use as a monotherapy and in combination with remdesivir against a placebo for the use in individuals with critical COVID-19.
“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,” Jonathan Javitt, MD, MPH, chairman and CEO of NRx, said in a statement. “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.”1
The study leadership indicated that enrollment has been steady, and the Delta surge has not been dissipating.
The majority of individuals enrolled are unvaccinated.
The NIH expects to include the first patient in Brazil in the study in February 2022.
ACTIV-3b is a placebo-controlled, randomized clinical trial for individuals who are hospitalized with acute respiratory failure because of COVID-19 who require high-flow supplemental oxygen delivered by extracorporeal membrane oxygenation, mechanical ventilation, or nasal cannula.
The study is 1 of 3 ongoing studies of aviptadil in severe or critical COVID-19.
In November, NRx announced that the FDA completed its review of updated manufacturing information for aviptadil allowing the company to distribute aviptadil, produced at a commercial scale, under good manufacturing practices (GMP) for clinical trials and other future purposes approved in future regulatory actions.2
Aviptadil was never manufactured as a commercial drug for intravenous use before the COVID-19 pandemic.
The FDA at that time reviewed a GMP manufacturing process at a batch size of 10,000 to 100,000 with a shelf life of 150 days and identified no basis for a clinical hold.
“This represents the first time aviptadil has been manufactured in an FDA-inspected commercial GMP environment for intravenous and inhaled use and passed regulatory review of manufacturing and CMC. With the help of our partners at Nephron Pharmaceuticals, we have validated the analytic techniques required to test the purity, potency, and stability of our medicine as required by the FDA and other regulators,” Javitt said in a statement.2
“We have advanced a generic ingredient (aviptadil) into a modern drug that meets GMP specifications, and that can be manufactured at commercial scale, cost, and shelf life,” he said. “While we continue to focus on proving clinical safety and efficacy in the treatment of COVID-19, we now have an investigational drug platform, reviewed by FDA, that enables us to investigate the use of Zyesami in both intravenous and inhaled form for a myriad of other lethal conditions that cause lung injury.”2
1. 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. NRx Pharmaceuticals. News release. December 14, 2021. Accessed December 14, 2021. Email.
2. NRx Pharmaceuticals receives US Food and Drug Administration review of Zyesami (aviptadil) manufacturing information. News release. November 11, 2021. Accessed 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