The Independent Data Monitoring Committee (IDMC) has conducted a planned conditional power analysis of the first 75 randomized patients in Veru Inc's (NASDAQ:VERU) Phase 3 trial of sabizabulin.
- The trial included hospitalized patients with moderate to severe COVID-19 infection at high risk for acute respiratory distress syndrome (ARDS) and death.
- IDMC has concluded that the clinical study should continue as initially designed.
- The IDMC performed this planned conditional statistical power analysis and review of the safety of the first 75 study patients to reach the primary endpoint.
- Related: Veru's Cancer Candidate Sabizabulin Gets FDA Fast Track Tag For COVID-19.
- Current full study recruitment is on track to yield clinical results in 1H of 2022.
- The Phase 3 COVID-19 clinical study is evaluating daily oral 9 mg sabizabulin for up to 21 days versus placebo in 300 hospitalized patients.
- The primary efficacy endpoint will be the proportion of patients that die on study up to Day 60.
- Price Action: VERU shares are trading 3.14% higher at $6.56 during the market session on the last check Monday.
