- Based on the review of approximately 460 patients, Data Safety and Monitoring Board (DSMB) determined that the evaluation of NRx Pharmaceuticals Inc's (NASDAQ:NRXP) Zyesami (aviptadil) should cease due to futility.
- Aviptadil was the sole remaining investigational medicine in ACTIV-3b targeted at critical-ill COVID-19 patients.
- ACTIV-3b study evaluated Zyesami and Gilead Sciences Inc's (NASDAQ:GILD) Veklury (remdesivir) as monotherapy and in combination against placebo.
- Also Read: NRx Pharmaceuticals Again Requests For FDA Breakthrough Therapy Status For COVID-19 Therapy.
- The DSMB recommended stopping further randomization to Zyesami (aviptadil) due to aviptadil not meeting the futility guidelines outlined by the pre-approved analytical plan.
- The primary endpoint and the 90-day mortality secondary endpoint were not supportive, with 37% mortality in the aviptadil group vs. 36% in the placebo group.
- There were no safety concerns, and the known side effects of aviptadil (principally diarrhea and hypotension) were managed well with the protocols in place.
- The trial is sponsored by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.
- Price Action: NRXP shares are down 43.5% at $0.78 during the premarket session on the last check Thursday.
