NRx Pharmaceuticals (NRXP) said that new finding from its phase 2b/3 trial of Zyesami has demonstrated clinically significant relief from respiratory distress in critical COVID-19. The trial evaluated Zyesami or aviptadil for the treatment of patients with acute Respiratory Failure due to Critical COVID-19.
In Monday pre-market trade, NRXP was trading at $15.26 up $1.26 or 9.00%.
The 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, the company said in a statement.
The company noted that the previously announced results have focused on survival and recovery from respiratory failure at 60 days, and Zyesami's apparent role in preventing rise in the inflammatory cytokine IL-6, known as "Cytokine Storm."
The company said it has provided updated data to the U.S. Food and Drug Administration in the support of the emergency use authorization request for zyesami.
NRx believes the new finding illustrates Zyesami's mechanism of action in a placebo-controlled trial and supports its application for Breakthrough Therapy Designation to the FDA.
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