Veru Inc (NASDAQ:VERU) has announced positive efficacy and safety results from a planned interim analysis of Phase 3 COVID-19 trial evaluating oral sabizabulin 9 mg versus placebo.
- The trial included 150 hospitalized COVID-19 patients at high risk for Acute Respiratory Distress Syndrome (ARDS).
- Sabizabulin treatment resulted in a clinically and statistically meaningful 55% relative reduction in deaths.
- The placebo group (n=52) had a 45% mortality rate compared to the sabizabulin-treated group (n=98), with a 20% mortality rate. The secondary efficacy endpoints are still being analyzed.
- Related: Veru's Cancer Candidate Sabizabulin Gets FDA Fast Track Tag For COVID-19.
- Sabizabulin treatment was well tolerated with no clinically relevant safety observations in the sabizabulin treated group compared to placebo.
- The Independent Data Safety Monitoring Committee unanimously recommended that the Phase 3 study be halted early due to efficacy, and they further remarked that no safety concerns were identified.
- The company plans to meet with the FDA to discuss the next steps, including submitting an emergency use authorization application.
- Price Action: VERU shares are up 197% at $12.92 on the last check Monday.
