Phase III COVID-19 study of VERU 111 halted for clear demonstration of efficacy in COVID-19 ARDS

In a double-blind, multicenter, and placebo-controlled Phase III clinical study evaluating sabizabulin 9 mg versus placebo (randomized 2:1) in 204 hospitalized moderate-severe COVID-19 patients (requiring oxygen) who were at high risk for ARDS and death (NCT04842747).

At a planned interim analysis in the first 150 patients randomized, the study was halted by the Independent Data Monitoring Committee for clear demonstration of efficacy. For the primary endpoint which was all cause mortality by Day 60, a clinically meaningful and statistically significant 55.2% relative reduction in deaths was observed in the intent-to-treat population (p=0.0041). Sabizabulin treatment also resulted in a 43% relative reduction in days in ICU (p=0.0013), 49% relative reduction in days on mechanical ventilation (p=0.0013), and 26% relative reduction in days in hospital (p=0.0277) vs placebo. The proportion of patients with an adverse event or a serious adverse event was lower in the sabizabulin compared to the placebo group. Sabizabulin is an oral, novel microtubule disruptor that has dual antiviral and anti-inflammatory activity.