The Food and Drug Administration (FDA) has granted Fast Track designation to sabizabulin for the treatment of hospitalized COVID-19 patients at high risk for acute respiratory distress syndrome (ARDS).
Sabizabulin is an oral cytoskeleton disruptor that blocks microtubule trafficking. The investigational treatment is expected to provide both antiviral and anti-inflammatory effects, thereby treating both the SARS-CoV-2 infection and the cytokine storm and septic shock that lead to ARDS.
Sabizabulin is being evaluated in a double-blind, multicenter, randomized, placebo-controlled trial (ClinicalTrials.gov Identifier: NCT04842747) that will enroll 300 patients hospitalized with COVID-19. Two hundred participants will receive sabizabulin once daily for up to 21 days, while 100 will receive placebo/standard of care. The trial will assess the effect of sabizabulin on the proportion of patients that die on study up to day 60 (primary endpoint).
Results are expected in the first half of 2022.
Mitchell Steiner, MD, CEO of Veru said: “We strongly believe that sabizabulin with its antiviral 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.”
Veru announces FDA grant of Fast Track designation for sabizabulin for the treatment of hospitalized COVID-19 patients at high risk for acute respiratory distress syndrome. News release. January 31, 2022. https://www.globenewswire.com/news-release/2022/01/31/2375780/11676/en/Veru-Announces-FDA-Grant-of-Fast-Track-Designation-for-Sabizabulin-for-the-Treatment-of-Hospitalized-COVID-19-Patients-at-High-Risk-for-Acute-Respiratory-Distress-Syndrome.html