By Chris Wack
NRx Pharmaceuticals Inc. shares were up 39%, to $9.47, in premarket trading after the company said 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.
The analysis showed the subgroup of patients in the trial that remained in respiratory failure despite treatment with remdesivir. The analysis identified a statistically-significant 2.5 fold increased odds of being alive and free of respiratory failure at 60 days and a statistically significant 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 U.S. Food and Drug Administration prior to initiation of the trial and remdesivir didn't 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 FDA recently declined Emergency Use Authorization and Breakthrough Therapy Designation for Zyesami and asked for a new request based on new clinical evidence that aviptadil may demonstrate a significant improvement in treatment over existing therapies.
Write to Chris Wack at [email protected]
(END) Dow Jones Newswires
November 29, 2021 09:25 ET (14:25 GMT)
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