Positive results were announced from a phase 3 trial evaluating sabizabulin in 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.
The double-blind, randomized, placebo-controlled trial (ClinicalTrials.gov Identifier: NCT04842747) included approximately 210 patients hospitalized with moderate to severe COVID-19 (WHO Ordinal Scale for Clinical Improvement score of at least 4) who were at high risk for ARDS and death.
Patients were randomly assigned 2:1 to receive sabizabulin orally once daily for up to 21 days or placebo. Both treatment arms were allowed to receive standard of care, which included remdesivir, dexamethasone, anti-interleukin 6 (IL6) receptor antibodies, and Janus kinase (JAK) inhibitors.
The primary endpoint was the proportion of patients who died by day 60. The key secondary endpoint was the proportion of patients who were alive without respiratory failure at day 15, day 22, and day 29.
An interim analysis showed that treatment with sabizabulin resulted in a clinically and statistically meaningful 55% relative reduction in deaths in the intent to treat population (P =.0029). The mortality rates for the sabizabulin and placebo groups were reported to be 20% and 45%, respectively. As for safety, sabizabulin was well tolerated with no clinically relevant safety concerns compared with placebo. According to the Company, secondary efficacy endpoints are still being analyzed.
Based on these positive efficacy and safety results, the independent Data Safety Monitoring Committee has recommended that the trial be stopped early. Veru intends to meet with the Food and Drug Administration (FDA) to discuss next steps including the submission of an emergency use authorization application.
“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,” said Gary Barnette, PhD, Chief Scientific Officer of Veru.
The FDA previously granted Fast Track designation to sabizabulin for this indication.
Veru’s novel COVID-19 drug candidate reduces deaths by 55% in hospitalized patients in interim analysis of phase 3 study; Independent Data Monitoring Committee halts study early for overwhelming efficacy. News release. Veru Inc. Accessed April 11, 2022. https://www.globenewswire.com/news-release/2022/04/11/2419839/11676/en/Veru-s-Novel-COVID-19-Drug-Candidate-Reduces-Deaths-by-55-in-Hospitalized-Patients-in-Interim-Analysis-of-Phase-3-Study-Independent-Data-Monitoring-Committee-Halts-Study-Early-for-.html