Clinical Evidence Indicates Improvement After COVID-19 Treatment

Pennsylvania-based NRx Pharmaceuticals announced today that it had completed an analysis to identify clinical evidence indicating 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 A. Schoenfeld to analyze the subgroup of patients in the COVID-AIV phase 2/3 clinical trial 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, it identified 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 (Veklury) was prespecified as a covariate in the protocol agreed to with the U.S. Food and Drug Administration (FDA) before initiation of the trial.

The 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).

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 FDA recently declined Emergency Use Authorization 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."

The National Institutes of Health-sponsored this trial to compare the effects of ZYESAMI and remdesivir individually and in combination continues to enroll patients.

Zyesami (Aviptadil) is a formulation of synthetic human Vasoactive Intestinal Peptide (VIP), which was first discovered in 1970.

Because of its lack of toxicity and low cost of manufacture compared to proprietary biologics, VIP may be uniquely attractive to those focused on global countermeasures against COVID-19, says the Company.

David Alan Schoenfeld, Ph.D., is a Professor (emeritus) of Medicine at Harvard Medical School and was a Professor of Public Health at the Harvard TH Chan School of Public Health.