NRx Pharmaceuticals has provided a safety update on Zyesami (aviptadil), which is being tested in the ACTIV-3 Critical Care phase-III study sponsored by the National Institutes of Health (NIH). The study’s Data Safety Monitoring Board found no new safety concerns in the trial and recommended continued enrollment, a company statement said.
The statement notified that ACTIV-3 is a randomised, blinded and placebo-controlled clinical trial testing Zyesami and the antiviral Remdesivir (veklury) in hospitalised patients with acute respiratory failure due to COVID-19 who require high-flow supplemental oxygen, delivered by nasal cannula, mechanical ventilation, or extracorporeal membrane oxygenation.
Study investigators are randomising patients to receive one of the four treatment regimens in addition to standard of care: both Zysami and Remdesivir, Zyesami and a placebo, Remdesivir and placebo, or only placebo. Zyesami is administered as a daily 12-hour intravenous infusion over three days. Those randomised to receive Remdesivir will receive it for up to 10 days via intravenous infusion, the statement added.
It also said that after review of approximately 140 patients, no new safety concerns were raised by the Data Safety Monitoring Board.
Zyesami is a proprietary and synthetic version of Vasoactive Intestinal Peptide (VIP), which is made naturally in the human body and appears to have lung-protective, anti-viral and anti-inflammatory effects.
ACTIV-3 represents one of the three ongoing studies of Zyesami in severe or critical COVID-19 patients.