NRx Pharmaceuticals has reported that its experimental drug, Zyesami (aviptadil), was found to be safe to treat Covid-19 in the Phase III ACTIV-3b Critical Care clinical trial sponsored by the US National Institutes of Health (NIH).
A synthetic form of a vasoactive intestinal polypeptide, Zyesami attaches to the lung air sac’s alveolar type II cells.
The placebo-controlled, randomised trial is analysing Zyesami and remdesivir (Veklury) as a single agent and in combination versus placebo in hospitalised Covid-19 patients with acute respiratory failure.
These subjects also needed high-flow supplemental oxygen offered by mechanical ventilation, nasal cannula or extracorporeal membrane oxygenation.
The Independent Data Safety Monitoring Board (DSMB) of the trial conducted the third scheduled assessment reviewing more than 300 subjects and detected no novel safety concerns associated with the treatment.
Furthermore, the DSMB recommended advancing the enrolment to recruit a total of 640 subjects in the trial.
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NRx Pharmaceuticals chairman and CEO professor Jonathan Javitt said: “This safety analysis by the NIH continues to contribute evidence that Zyesami is safe to administer to patients with critical Covid-19, who have no other therapeutic alternative.
“We now have safety data on nearly 600 patients treated with Zyesami in the ICU or step-down unit, with no reports of unexpected, drug-related, serious adverse events.”
The company had sought emergency use authorization from the US Food and Drug Administration for Zyesami to treat critical Covid-19 patients with respiratory failure, in May 2021.
NRx noted that the application is still pending.
Apart from the ACTIV-3b study, Zyesami is being analysed in two other trials in subjects with severe or critical Covid-19.
In September 2021, NRx reported top-line data from a trial where Zyesami boosted survival outcomes at 12 months in highly comorbid Covid-19 patients.