NRx Pharmaceuticals (NSDQ:NRXP) announced that it applied for FDA emergency use authorization based on a study of its Zyesami therapeutic.
Radnor, Pa.-based NRx Pharmaceuticals, formerly NeuroRx, just last week completed a merger with SPAC Big Rock Partners Acquisition Corp. and went public, changing its name in the process.
The company develops Zyesami, a synthetic form of a naturally occurring peptide — vasoactive intestinal peptide (VIP) — found in the lung and known to protect the Alveolar Type II cell targeted by SARS-CoV-2, the virus causing COVID-19. The company entered a feasibility agreement with TFF Pharmaceuticals to formulate Zyesami into a dry powder to treat COVID-19 in March.
According to a news release, a study identified a statistically significant increase in the likelihood that COVID-19 patients treated with Zyesami would be alive and free of respiratory failure at 60 days, compared to those treated with placebo, while also enduring a significantly shorter median hospital stay.
The study enrolled 196 patients across 10 U.S. hospitals, with patients in earlier stages of respiratory failure (being treated with high-flow oxygen) more likely to survive and recover than those who progressed with ventilation. Both groups demonstrated statically significant benefits in the prespecified endpoint, though.
“The patients enrolled in our study were in the ICU, having exhausted all approved treatments for COVID-19,” NRx chairman & CEO Dr. Jonathan Javitt said in the release. “We look forward to working as quickly as possible with the FDA in hopes of providing critically ill patients with a new medicine that will increase their chances of recovery and survival, enabling them to leave the hospital and return to their families significantly sooner.”
NRx touted Zyesami as the first reported medicine to demonstrate increased recovery and survival in patients who already progressed to respiratory failure, with study outcomes falling in line with the company’s open-label trial reported in October 2020.
“Since this pandemic started, there have been very few medications to effectively treat COVID-19,” principal investigator Dr. Dushyantha Jayaweera, a professor of clinical medicine and former associate dean at the University of Miami, said. “The positive results from this trial turned into positive implications for some of our sickest COVID-19 patients and support the clinical benefit of Zyesami in critically-ill COVID-19 patients with respiratory failure. Even today, despite the availability of vaccines, we continue to see severely ill patients suffering with COVID-19, who desperately need new medicines to help them recover.”