Phase III COVID-19 trial evaluating oral VERU 111 halted early by IDSM for efficacy in COVID-19 ARDS.

The Independent Data Safety Monitoring Committee unanimously recommended that the Phase III study be halted early due to efficacy, and they further remarked that no safety concerns were identified.

The Phase III COVID-19 study is a double-blind, randomized, placebo-controlled Phase III clinical trial evaluating oral, once-a-day dosing of sabizabulin 9 mg versus placebo in approximately 210 hospitalized moderate to severe COVID-19 patients (at least WHO 4) who were at high risk for ARDS and death. Patients were randomized in a 2:1 ratio to the sabizabulin treatment group versus placebo. Patients in both treatment groups were allowed to receive standard of care including remdesivir, dexamethasone, anti-IL6 receptor antibodies, and JAK inhibitors. The trial was conducted in the United States, Brazil, Colombia, Argentina, Mexico, and Bulgaria. COVID-19 infections treated in the study included the Delta and Omicron variants. A planned interim analysis was conducted in the first 150 patients randomized into the study. The primary efficacy endpoint was the proportion of patients that died by Day 60.

The prespecified primary endpoint was death at or before day 60. Sabizabulin treatment resulted in a clinically and statistically meaningful 55% relative reduction in deaths (p=0.0029) in the intent to treat population. Placebo group (n=52) had a 45% mortality rate compared to the sabizabulin-treated group (n=98) which had a 20% mortality rate. The secondary efficacy endpoints are still being analyzed at the time of this release. Sabizabulin treatment was well tolerated in this patient population with no clinically relevant safety observations in the sabizabulin treated group compared to placebo.