NRx Pharmaceuticals (NASDAQ: NRXP) has announced an additional finding in the Phase 2b/3 clinical study evaluating ZYESAMI (aviptadil) in Critical COVID-19 induced acute respiratory failure treatment.
ZYESAMI can reduce respiratory distress
The study’s previous findings focused on survival and recovery from respiratory failure after 60 days, as well as ZYESAMI’s apparent role in avoiding the inflammatory cytokine IL-6, sometimes described as “Cytokine Storm.”
According to NRx’s recent investigation, individuals treated with ZYESAMI demonstrated significant improvement in blood oxygen levels within a day after beginning therapy, indicating enhanced lung function. In addition, the difference in Respiratory Distress Ratio among those who received aviptadil and those who received placebo were both clinically and statistically meaningful. Furthermore, the change is equivalent to that published a year ago by Dr. J Georges Yousef in an open-label research at Houston Methodist Hospital last year.
CEO Jonathan Javitt said, “With the conclusion of the analysis of primary and secondary endpoints, we are able to focus on prespecified endpoints that confirm the mechanism of action. COVID-19 attacks the cells that line the lung in a manner that prevents them from transmitting oxygen to the body. It is this respiratory failure that starts the lethal process of COVID. This latest analysis provides confirmatory evidence that aviptadil improves the lung’s ability to transmit oxygen within a day of initiating treatment. The benefit was seen across all patients, all baseline severities, and all types of hospitals. We believe this new finding illustrates ZYESAMI’s mechanism of action in a placebo-controlled trial and supports our application for Breakthrough Therapy Designation to the FDA.”
NRx to file for Breakthrough Therapy Designation
Youssef, Head of Academic Pulmonary Medicine at Houston Methodist Hospital, revealed previous evidence on reduced respiratory distress a year ago. He and other researchers compared the outcomes of 21 ZYESAMI-treated patients to 24 patients who got the best available standard of care. This new analysis backs up NRx’s application to the FDA for Breakthrough Therapy Designation (BTD) for ZYESAMI.
