by Chris Wack
NRx Pharmaceuticals Inc. in premarket trading. Shares of Zyesami rose 39% to $9.47 after the company said it had completed an analysis to identify clinical evidence that could be relevant to treatment with Zyesami aviptadil in patients with significant COVID-19 and respiratory failure. The latter indicates substantial improvement. Existing treatments such as remdesivir.
The analysis showed a subgroup of patients in the trial who persisted in respiratory failure despite treatment with remdesivir. The analysis revealed a statistically significant 2.5-fold increase in the likelihood of relapse of respiratory failure at 60 days and survival at day 60 in patients treated with aviptadil compared to patients treated with placebo. has a four-fold higher odds of being statistically significant.
Baseline treatment with remdesivir was determined as a covariate in a protocol agreed with the US Food and Drug Administration prior to initiation of the trial and remdesivir showed no independent survival or recovery benefit in the subgroup. 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 substantial improvement over existing therapies.
The FDA recently denied 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 treatments. .
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