Veru Shares Rise as Novel COVID-19 Drug Candidate Reduces Deaths by 55%

Apr 11, 2022 By MarketDepth

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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.

First Drug to Reduce Deaths

“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.

Given to Moderate to Severe Patients

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 (≥WHO 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.

“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.”

Gary Barnette, PhD, Chief Scientific Officer of Veru

‘We expect new COVID-19 variant infections and new challenges in the treatment of hospitalized patients, particularly as the country heads into the fall and winter seasonal cycle. With the results of this Phase 3 COVID-19 study, we now have a treatment option for the sickest hospitalized COVID patients,” said Alan Skolnick, M.D., Principal Investigator with HD Research, who conducted this Phase 3 COVID-19 study at Memorial Hermann Memorial City Medical Center in Houston TX. “We have battled this pandemic for almost two and a half years now. A 55% reduction in deaths in hospitalized patients is tremendously meaningful to patients, their families, doctors, nurses, hospital staff and the communities they serve,” added Dr. Skolnick.