FDA Grants Fast Track Designation to Sabizabulin for COVID-19 Treatment

Yesterday, Veru announced the US Food and Drug Administration (FDA) granted Fast Track designation for the phase 3 investigation of sabizabulin to treat COVID-19.

Sabizabulin is a novel, proprietary oral cytoskeleton disruptor with anti-viral and anti-inflammatory properties. It was developed to combat COVID-19 infection in hospitalized patients at high risk for the cytokine storm responsible for acute respiratory distress syndrome (ARDS) and death.

The FDA Fast Track designation will expedite the development of sabizabulin to treat COVID-19 and prevent ARDS, a significant unmet medical need.

Mitchell Steiner, MD, president and chief executive officer of Veru Inc., said in a statement, “COVID-19 global cases, hospitalizations, and deaths are at the highest levels since the start of the pandemic. Some of the antibody drugs are not effective against the Omicron variant. It is clear that an effective and safe oral therapeutic that prevents deaths in hospitalized patients with moderate to severe COVID-19 disease who are at high risk for ARDS is desperately needed. We strongly believe that sabizabulin with its anti-viral and anti-inflammatory properties and a favorable safety profile can be that greatly needed oral therapy for hospitalized COVID-19 patients with serious illness. We look forward to ongoing, productive regulatory interactions with the FDA, which are further enabled with this designation.”

Sabizabulin is a cytoskeleton disruptor that blocks microtubule trafficking. Microtubule trafficking is a crucial process that enables viruses to transport, replicate, assemble, and release from a cell, as well as contributing to inflammatory processes such as cytokine release syndrome. By inhibiting microtubule trafficking, sabizabulin is able to treat COVID-19 infection and the cytokine storm and septic shock that may lead to ARDS and mortality.

The sabizabulin double-blind, multicenter, multinational, randomized, placebo-controlled phase 3 clinical trial expects results in the first half of 2022. The trial is investigating daily oral doses of 9 mg sabizabulin for up to 21 days as compared to a placebo. Participants include 300 subjects hospitalized with COVID-19 and at high risk of ARDS, 200 of whom are treated with sabizabulin and 100 who received placebo. All participants will also receive standard care as needed.

The primary endpoint of the trial is the number of participants who die during the study through day 60. Secondary efficacy endpoints will be the proportion of patients without respiratory failure, the World Health Organization (WHO) Ordinal Scale for Clinical Improvement change from study baseline, viral load, and number of days in the intensive care unit, on mechanical ventilation, and in the hospital. The study is currently conducted in the US, Brazil, Argentina, Mexico, Columbia, and Bulgaria.

Veru Inc. is a biopharmaceutical company with primary focus in oncology, with interest in developing novel therapies to treat breast and prostate cancers.