The Independent Data Monitoring Committee (IDMC) has conducted a planned conditional power analysis of the first 75 randomized patients in Veru Inc's
(Get Free Alerts for 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.
- 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.
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