NRx Pharmaceuticals, a clinical stage, biopharmaceutical company today provided a safety update on ZYESAMI (aviptadil) which is being tested in the ACTIV-3 Critical Care Phase 3 study sponsored by the National Institutes of Health. The study’s Data Safety Monitoring Board found no new safety concerns in the trial and recommended continued enrollment.
ACTIV-3 is a randomized, blinded, placebo-controlled clinical trial testing ZYESAMI and the antiviral remdesivir (Veklury) in hospitalized 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 randomizing patients to receive one of four treatment regimens in addition to standard of care: both ZYESAMI 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 randomized to receive remdesivir will receive it for up to 10 days via intravenous infusion.
ZYESAMI (aviptadil) is a proprietary, synthetic version of Vasoactive Intestinal Peptide or 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 three ongoing studies of ZYESAMI in Severe or Critical COVID-19.