Independent Data Monitoring Committee for the phase III sabizabulin COVID-19 clinical study recommends continuing study as planned.
Veru Inc. 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 III 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 III 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.
The Phase III COVID-19 study is being conducted in the United States, Brazil, Argentina, Mexico, Colombia and Bulgaria and is on track. Clinical results are expected in the first half of calendar year 2022.
Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer of Veru Inc noted: “COVID-19 global cases are at exceedingly high levels. In fact, the Omicron variant has driven the US death toll higher than at any point during the Fall of 2021’s Delta variant peak. It is clear that an effective and safe oral therapeutic that prevents deaths in hospitalized patients with moderate to severe COVID-19 disease who are at high risk for ARDS is desperately needed. FDA has confirmed by granting Fast Track that an effective therapy for hospitalized patients with COVID-19 remains an unmet medical need. We strongly believe that sabizabulin with its anti-viral and anti-inflammatory properties and a favorable safety profile may be that greatly needed oral therapy for these hospitalized COVID-19 patients at risk for ARDS.”