Veru Reports Positive Phase 2 Clinical Results of VERU-111 in Hospitalized COVID-19 Patients at High Risk for Acute Respiratory Distress Syndrome

Veru Inc. an oncology biopharmaceutical company, today announced positive efficacy and safety results from a double-blind, randomized, placebo-controlled Phase 2 clinical trial evaluating oral, once-a-day dosing of VERU-111 versus placebo in approximately 40 hospitalized patients at high risk for Acute Respiratory Distress Syndrome (ARDS) from SARS-CoV-2.

“We are very pleased with the results of our Phase 2 trial, which demonstrated clinically meaningful reductions in relevant endpoints, including respiratory failure, days in the ICU and on mechanical ventilation and patient mortality. We believe VERU-111 has significant potential in treating COVID-19, both as a broad-spectrum antiviral and an anti-inflammatory agent, helping to prevent the effects that lead to ARDS and death,” 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 are 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. We look forward to our upcoming discussion with FDA concerning the regulatory and clinical development steps to move VERU-111 for COVID-19 forward.”

“We are in critical need of effective drugs in high-risk COVID-19 patients. The slow rollout of COVID-19 vaccines, the emergence of new mutant COVID-19 strains and the lack of truly effective drugs in hospitalized, high-risk patients make it critical that we advance VERU-111 and confirm these impressive results in a Phase 3 clinical study as quickly as possible,” said Alan Skolnick, M.D., Principal Investigator with HD Research, who conducted the trial at Memorial Hermann Memorial City Medical Center in Houston TX. “The results of the Phase 2 trial were strengthened by the strict parameters in place, which included a blinded, placebo-controlled, randomized study that also allowed standard of care for both the treated and the placebo groups in hospitalized patients at high risk for ARDS.”