DJ Veru Gets FDA Approval to Move Covid-19 Treatment Into Phase 3 Study

By Chris Wack

Veru Inc. said the U.S. Food and Drug Administration agreed in an end of Phase 2 meeting to advance VERU-111 into a Phase 3 registration clinical study.

The biopharmaceutical company said the FDA's move is based on the clinically meaningful benefits observed with VERU-111 treatment in the recently completed Phase 2 clinical trial evaluating oral, once-a-day dosing of VERU-111 versus placebo in 40 hospitalized Covid-19 patients at high risk for ARDS.

Veru said the Phase 2 trial saw clinically meaningful reductions in relevant endpoints, including respiratory failure, patient mortality, days in the ICU and days on mechanical ventilation. VERU-111 could act as an antiviral and an anti-inflammatory agent which is supported by positive Phase 2 clinical study results.

The company said it has met with and will seek funding from The Biomedical Advanced Research and Development Authority of the U.S. Department of Health and Human Services, as well as other agencies, to fund the estimated amount of commercial drug to supply the needs of the U.S. population, assuming confirmatory positive Phase 3 clinical results and FDA approval.

Veru shares were up 15% to $15.93 in premarket trading.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

March 01, 2021 09:18 ET (14:18 GMT)

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