RADNOR, PA — NRx Pharmaceuticals (Nasdaq: NRXP) announced this week that it has completed an analysis to identify clinical evidence that indicates a substantial improvement after treatment with ZYESAMI® (aviptadil) in patients with Critical COVID-19 and Respiratory Failure over existing therapies such as remdesivir. NRx asked Prof. David Schoenfeld, one of the world’s most widely published statisticians with unique expertise in life-threatening diseases of the lung to conduct the analysis.
Dr. Schoenfeld analyzed the subgroup of patients in the COVID-AIV trial (NCT 04311697) that remained in respiratory failure despite treatment with remdesivir. The analysis identified a statistically-significant (P=.03) 2.5 fold increased odds of being alive and free of respiratory failure at 60 days (the primary endpoint) and a statistically significant (P=.006) four-fold higher odds of being alive at day 60 among patients treated with aviptadil compared to those treated with placebo.
Baseline treatment with remdesivir was prespecified as a covariate in the protocol agreed to with the US Food and Drug Administration (FDA) prior to initiation of the trial and remdesivir did not show any independent survival or recovery advantage in the subgroup. Analysis of the remdesivir-treated subgroup was a post-hoc analysis performed in response to the FDA’s request for additional clinical evidence that aviptadil may demonstrate a substantial improvement over existing therapies.
The reanalysis of the clinical trial data additionally confirmed a statistically-significant (P=.03) two-fold survival advantage seen across all patients treated with aviptadil compared to those treated with placebo and demonstrated an increased odds of reaching the primary endpoint in the study, being both alive and free of respiratory failure at 60 days that approached statistical significance (P=.08).
The FDA recently declined Emergency Use Authorization (EUA) and Breakthrough Therapy Designation (BTD) for ZYESAMI and invited a new request based on new clinical evidence that aviptadil may demonstrate a significant improvement in treatment over existing therapies. Based on FDA’s input, NRx has narrowed its requested BTD indication to “Treatment of COVID-19 Respiratory Failure in patients who progress despite treatment with remdesivir and other approved therapies.”
Dr. Schoenfeld’s report concludes, “The study provides preliminary evidence that aviptadil is effective in increasing the odds of recovery and survival from respiratory failure among the sickest COVID patients overall and particularly in those whose respiratory failure has progressed despite treatment with remdesivir. The study shows a significant increase in the likelihood that patients will recover and leave the ICU and a four-fold increase in the odds of survival after treatment with aviptadil compared to placebo, among the 127 patients who remained in respiratory failure despite treatment with remdesivir.”
“We appreciate Dr. Schoenfeld’s wisdom and insight based on his vast experience with studies of Acute Respiratory Distress, such as ours,” said Prof. Jonathan Javitt, MD, MPH, CEO and Chairman of NRx Pharmaceuticals. “The definitive findings on our medicine will come from the global trial currently being conducted by the NIH, which is more than halfway enrolled. However, at a time when COVID deaths are surging, we hope that the FDA will consider these new clinical findings in patients who have exhausted currently-approved therapies.”
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