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Veru Reports that Independent Data Monitoring Committee for the Phase 3 Sabizabulin COVID-19 Clinical Study Recommends Continuing Study as Planned
--Planned Conditional Statistical Power Analysis was Conducted— --Primary Efficacy Study Endpoint Is Proportion of Patients that Die on Study Up to Day 60--
About this update from Veru Inc.
[{"type":"text","content":"--Planned Conditional Statistical Power Analysis was Conducted— --Primary Efficacy Study Endpoint Is Proportion of Patients that Die on Study Up to Day 60-- --Global Phase 3 Sabizabulin COVID-19 Clinical Study for Treatment of Hospitalized Moderate to Severe COVID-19 Patients at High Risk for Acute Respiratory Distress Syndrome on Track and Clinical Results Expected 1H 2022-- MIAMI, Feb. 14, 2022 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU) today announced that the Independent Data Monitoring Committee (IDMC) has conducted a planned conditional power analysis of the first 75 randomized patients in the Global Phase 3 COVID-19 registration study evaluating novel oral sabizabulin in hospitalized patients with moderate to severe COVID-19 infection who are at high risk for acute respiratory distress syndrome (ARDS) and death and has concluded the clinical study should continue as originally designed. The IDMC performed this planned conditional statistical power analysis and review of safety of the first 75 study patients to reach the primary endpoint. Current full study recruitment is on track to yield clinical results in the first half of calendar year 2022. The Phase 3 COVID-19 clinical study is a double-blind, multicenter, multinational, randomized (2:1), placebo-controlled study evaluating daily oral 9 mg sabizabulin for up to 21 days versus placebo in 300 hospitalized patients who have moderate to severe infection and who are at high risk for ARDS. Subjects will also be allowed to receive standard of care. The primary efficacy endpoint will be the proportion of patients that die on study up to Day 60. Secondary endpoints will include the proportion of patients without respiratory failure, days in ICU, WHO Ordinal Scale for Clinical Improvement change from baseline, days on mechanical ventilation, days in the hospital, and viral load. In January 2022, the Phase 3 COVID-19 program received Fast Track designation by FDA. Fast Track designation aims to expedite the development and review of new drugs that are intended to treat serious or life-threatening conditions and demonstrate the potential to fill unmet medical needs. Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially better than available therapy. The Phase 3 COVID-19 study is being conducted in the...