Veru Announces FDA Fast Track Designation for Sabizabulin for the Treatment of Hospitalized COVID-19 Patients at High Risk for Acute Respiratory Distress Syndrome (ARDS)

Veru Inc. (NASDAQ: VERU) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to the Phase 3 registration program for the investigation of sabizabulin, a novel, proprietary, oral cytoskeleton disruptor with both anti-viral and anti-inflammatory properties, to combat COVID-19 infection and the cytokine storm that is responsible for Acute Respiratory Distress Syndrome (ARDS) and death. FDA Fast Track Designation is intended to expedite the development and review of new drugs to treat serious medical conditions that fill unmet medical needs. The global pandemic disease caused by the novel coronavirus SARS-CoV-2 is entering its 3^rd year, and there remains an unmet medical need for new effective treatments for hospitalized patients with moderate to severe COVID-19 symptoms at high risk for ARDS and death.

“We are very pleased that the sabizabulin therapeutic for COVID-19 clinical program has received Fast Track designation from the FDA, a distinction that underscores the urgent need for new, novel, effective therapies to be used along with vaccinations to combat this COVID-19 pandemic,” said Mitchell Steiner, MD, Chairman, President and Chief Executive Officer of Veru Inc.

Dr. Steiner added: “COVID-19 global cases, hospitalizations, and deaths are at the highest levels since the start of the pandemic. Some of the antibody drugs are not effective against the omicron variant. It is clear that an effective and safe oral therapeutic that prevents deaths in hospitalized patients with moderate to severe COVID-19 disease who are at high risk for ARDS is desperately needed. We strongly believe that sabizabulin with its anti-viral and anti-inflammatory properties and a favorable safety profile can be that greatly needed oral therapy for hospitalized COVID-19 patients with serious illness. We look forward to ongoing, productive regulatory interactions with the FDA, which are further enabled with this designation.”

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