Veru Inc. an oncology biopharmaceutical company with a focus on developing novel medicines for the management of prostate and breast cancer, announced that it has enrolled the first patient in its Phase 3 clinical trial of sabizabulin, a novel, proprietary, oral cytoskeleton disruptor with anti-inflammatory and anti-viral properties, to combat the effects of COVID-19, the global pandemic disease caused by the novel coronavirus SARS-CoV-2.
“COVID-19 infection rates and hospitalizations are still at serious levels. There are mutating and double mutating virus strains, and large parts of the population either unable or unwilling to get access to effective vaccines. In fact, global cases of COVID-19 are at the highest levels since the start of the pandemic. 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 risk for Acute Respiratory Distress Syndrome (ARDS) is desperately needed,” said Mitchell Steiner, MD, Chairman, President and Chief Executive Officer of Veru Inc. “We strongly believe that sabizabulin with its anti-inflammatory and anti-viral properties and its favorable safety profile can be that greatly needed oral therapy. With the aim of meeting our recruitment goals by year end, we have selected clinical sites in locations that have been hard hit by COVID-19 in the US, Brazil, Argentina, Colombia, and Mexico.”
Sabizabulin (VERU-111) Phase 3 Trial Design
The Phase 3 clinical trial is a double-blind, multicenter, multinational, randomized (2:1), placebo-controlled trial evaluating daily oral doses of 9mg sabizabulin for up to 21 days versus placebo in 300 hospitalized patients (200 subjects will be treated with sabizabulin and 100 subjects will receive placebo/standard of care) who tested positive for the SARS-CoV-2 virus and who are at high risk for ARDS. Because of better oral bioavailability, the systemic blood levels from the 9mg sabizabulin dosage are similar to the 18mg sabizabulin formulation used in the Phase 2 clinical study. Subjects in the sabizabulin and placebo arms 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 study will be conducted in the United States, Brazil, Argentina, Mexico, and Colombia. Enrollment is targeted to be completed by year-end.