Veru Inc. (NASDAQ: VERU) shares spiked about 44% after the Company announced positive efficacy and safety results from a planned interim analysis of the double-blind, randomized, placebo-controlled Phase 3 COVID-19 clinical trial evaluating oral sabizabulin 9 mg versus placebo in 150 hospitalized COVID-19 patients at high risk for Acute Respiratory Distress Syndrome (ARDS). The Independent Data Safety Monitoring Committee unanimously recommended that the Phase 3 study be halted early due to efficacy, and they further remarked that no safety concerns were identified.<\/p>\n\n\n\n
“This study represents a significant milestone in the global fight against COVID-19 as sabizabulin is the first drug to demonstrate a clinically and statistically meaningful reduction in deaths in hospitalized patients with moderate to severe COVID-19,” said Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer of Veru. “We strongly believe that sabizabulin, with its dual anti-viral and anti-inflammatory properties which demonstrated positive efficacy and safety results in the Phase 3 COVID-19 study, can be that greatly needed oral therapy for hospitalized moderate to severe COVID-19 patients,” Dr. Steiner continued.<\/p>\n\n\n\n
The Phase 3 COVID-19 study is a double-blind, randomized, placebo-controlled Phase 3 clinical trial evaluating oral, once-a-day dosing of sabizabulin 9 mg versus placebo in approximately 210 hospitalized moderate to severe COVID-19 patients (\u2265WHO 4) who were at high risk for ARDS and death. Patients were randomized in a 2:1 ratio to the sabizabulin treatment group versus placebo.<\/p>\n\n\n\n
“What makes these findings more relevant is that the pharmacological activity of sabizabulin is independent of COVID-19 variant type. Pending upcoming discussion with FDA, this treatment option may be made available soon so we can be ready for when the next clinically important wave of COVID infections comes.”<\/p>