Veru Receives FDA Agreement to Advance VERU-111 into Phase 3 Study in Hospitalized COVID-19 Patients at High Risk for Acute Respiratory Distress Syndrome (ARDS)

– Veru completes expedited end of Phase 2 trial meeting with FDA –

– FDA agrees that Phase 2 clinical findings suggest a clinically meaningful benefit for the use of VERU-111 in hospitalized COVID-19 patients at high risk for ARDS –

– FDA agrees to advance VERU-111 into Phase 3 clinical study in hospitalized high risk COVID-19 patients to confirm the potential benefit and risk –

– Phase 3 clinical study expected to begin in April 2021 with clinical results expected in calendar Q4 2021 –

MIAMI, March 01, 2021 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), an oncology biopharmaceutical company, today announced that the FDA agreed in an End of Phase 2 meeting, to advance VERU-111 into a Phase 3 registration clinical study based on the clinically meaningful benefits observed with VERU-111 treatment in the recently completed double-blind, randomized, placebo-controlled Phase 2 clinical trial evaluating oral, once-a-day dosing of VERU-111 versus placebo in approximately 40 hospitalized COVID-19 patients at high risk for ARDS. The Phase 2 trial demonstrated clinically meaningful reductions in relevant endpoints, including respiratory failure, patient mortality, days in the ICU and days on mechanical ventilation. VERU-111 has the potential for two-pronged action against COVID-19 as an antiviral and an anti-inflammatory agent which is supported by positive Phase 2 clinical study results.

“We are very pleased with the outcome of the FDA meeting. FDA was extremely collaborative and thought that the clinical data from the Phase 2 were promising and suggest a potential clinically meaningful benefit for the use of VERU-111 in hospitalized high risk COVID-19 patients. Also, the FDA agreed that VERU-111 warrants further development in a Phase 3 program,” said Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer of Veru. “Due to the urgency of the global pandemic and need for more effective treatment options for patients, we remain duty-bound to pursue this indication, even though it has not been the primary focus of Veru. We have the resources to conduct a Phase 3 trial without impacting our cancer drugs’ clinical development.”