Veru Publishes Phase 3 Study of Sabizabulin for Hospitalized COVID Patients at High Risk for Respiratory Distress

 Veru Inc. (NASDAQ: VERU), a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral and ARDS-related diseases and for the management of breast and prostate cancers, today announced that the Phase 3 COVID-19 study results of Sabizabulin for the Treatment of Hospitalized COVID-19 Patients at High Risk for Acute Respiratory Distress Syndrome (ARDS) were presented at the 11^th International Conference on Emerging Infectious Diseases (ICEID) on August 8, 2022.

Presentation Highlights

• Sabizabulin is an oral, novel microtubule disruptor that has dual antiviral and anti-inflammatory activity.
• In a double-blind, multicenter, and placebo-controlled Phase 3 clinical study evaluating sabizabulin 9 mg versus placebo (randomized 2:1) in 204 hospitalized moderate-severe COVID-19 patients (requiring oxygen) who were at high risk for ARDS and death (NCT04842747). At a planned interim analysis in the first 150 patients randomized, the study was halted by the Independent Data Monitoring Committee for clear demonstration of efficacy. For the primary endpoint which was all cause mortality by Day 60, a clinically meaningful and statistically significant 55.2% relative reduction in deaths was observed in the intent-to-treat population (p=0.0041). Sabizabulin treatment also resulted in a 43% relative reduction in days in ICU (p=0.0013), 49% relative reduction in days on mechanical ventilation (p=0.0013), and 26% relative reduction in days in hospital (p=0.0277) vs placebo. The proportion of patients with an adverse event or a serious adverse event was lower in the sabizabulin compared to the placebo group.

August 08, 2022: 4:15 PM – 4:30 PM Eastern Time
Oral Sabizabulin Reduces Mortality in Hospitalized COVID-19 Patients with at High Risk for ARDS
Oral Presentation Number: E4.5
Presenter: Michael Gordon MD, Chief Medical Officer at HonorHealth Research and Innovation Institute in Scottsdale, Arizona

Additional information on the meeting can be found on the ICEID website: https://www.iceid.org/

https://www.biospace.com/article/releases/veru-announces-presentation-of-phase-3-study-of-sabizabulin-for-the-treatment-of-hospitalized-covid-19-patients-at-high-risk-for-acute-respiratory-distress-syndrome/