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# Veru Reports Positive Data from Covid Therapy Trial
- URL: https://www.fdaweb.com/veru-reports-positive-data-from-covid-therapy-trial/
- Published: 2022-04-12T12:00:00.000Z
- Updated: 2026-09-14T17:40:19.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151570

Veru Inc. has announced positive efficacy and safety results from an interim analysis of a double-blind, randomized, placebo-controlled Phase 3 Covid-19 clinical trial evaluating oral sabizabulin 9 mg versus placebo in 150 hospitalized patients at high risk for Acute Respiratory Distress Syndrome. The company says the primary endpoint was death at or before day 60, whereas sabizabulin treatment showed a 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 company says, adding that secondary efficacy endpoints are still being analyzed.

The study’s independent data safety monitoring committee unanimously recommended that the study be halted early due to efficacy. The company plans to meet with FDA to discuss the submission of an emergency use authorization application. The agency granted the company a fast track designation in January for the therapy. Manufacturing has been scaled up to produce commercial supplies in anticipation of an emergency use authorization, the company says.