On Jun. 7, 2022, Veru, a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral and ARDS-related diseases and for the management of breast and prostate cancers, announced that is had submitted an emergency use authorization (EUA) application to the U.S. Food and Drug Administration for its sabizabulin oral 9mg treatment of moderate to severe hospitalized COVID-19 patients at high risk for developing Acute Respiratory Distress Syndrome (ARDS).

The EUA submission to the FDA was based on the positive results from the double-blind, randomized, multicenter placebo-controlled Phase 3 COVID-19 clinical trial evaluating the efficacy and safety of sabizabulin, an oral, first-in-class, new chemical entity, cytoskeleton disruptor that has dual anti-inflammatory and antiviral properties, in approximately 204 hospitalized COVID-19 patients with moderate to severe COVID (≥ WHO 4-supplemental oxygen) at high risk for ARDS and death. The primary efficacy endpoint was the proportion of deaths by Day 60. Based on a planned interim analysis of the first 150 patients randomized, the Independent Data Monitoring Committee unanimously halted the study for overwhelming efficacy which showed that sabizabulin 9mg once daily treatment resulted in a clinically meaningful and statistically significant 55.2% relative reduction in deaths. Sabizabulin was well tolerated.

The Company announced that it has submitted an EUA request to the FDA for its novel, oral, once daily sabizabulin treatment of moderate to severe hospitalized COVID-19 patients at high risk for ARDS.