No New Safety Concerns Found in Innovative COVID-19 Treatment

Pennsylvania-based NRx Pharmaceuticals announced a safety update on ZYESAMI™ (aviptadil), currently tested in the ACTIV-3 Critical Care Phase 3 study. The National Institutes of Health-sponsored study's Data Safety Monitoring Board found no new safety concerns in the trial and recommended continued enrollment targeting more than 600 COVID-19 patients.

After reviewing approximately 140 patients, no new safety concerns were raised by the Independent Board.

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 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, stated NRx's press release issued on August 18, 2021.

The ACTIV-3 inpatient protocol is designed with two stages of testing, allowing for quick analysis of compounds for effectiveness in Stage 1 and then a seamless progression to Stage 2 to validate the compound for broader use in patients. In addition, this protocol will enroll hospitalized patients with COVID-19 to evaluate investigational treatments for safety and efficacy in reducing time to recovery and effects on extrapulmonary complications and respiratory dysfunction.

Located in Radnor PA, NRx 'applies its unique clinical and scientific expertise, partnered with leading medical experts, to develop known molecules for medical conditions with no indicated therapies. NRx believes in a world where scientific advancement makes untreatable diseases treatable.' Jonathan C. Javitt, M.D., M.P.H., is the Chairman and CEO.