Drug developed by Ohio State Consortium shows promise in treating COVID-19 patients at high-risk for ARDS in Phase 3 study

Veru, a biopharmaceutical company, announced positive efficacy and safety results from a planned interim analysis of the double-blind, randomized, placebo-controlled Phase 3 COVID-19 clinical trial evaluating oral sabizabulin 9 mg versus placebo in 150 hospitalized COVID-19 patients at high risk for Acute Respiratory Distress Syndrome (ARDS).

The company plans to meet with FDA to discuss next steps including the submission of an emergency use authorization application.

The drug, originally developed as a treatment for prostate cancer, was partially developed by James Dalton during his time at Ohio State in the College of Pharmacy. Dalton is currently executive vice president and provost at the University of Alabama.

The intellectual property exclusively licensed on a global basis by Veru is owned jointly by Ohio State, the University of Tennessee and Oncternal Therapeutics, Inc., successor to GTx, Inc.

“What makes these findings more relevant is that the pharmacological activity of sabizabulin is independent of COVID-19 variant type. Pending upcoming discussion with FDA, this treatment option may be made available soon so we can be ready for when the next clinically important wave of COVID infections comes,” said Gary Barnette, PhD, Chief Scientific Officer of Veru.