A U.S. FDA advisory panel voted against granting emergency authorization to Veru's oral drug for treating high-risk patients hospitalized with COVID-19, citing multiple concerns based on data from a small trial.
The Pulmonary-Allergy Drugs Advisory Committee, which reviewed sabizabulin for Emergency Use Authorization in hospitalized moderate to severe COVID-19 patients who are at high risk for acute respiratory distress syndrome, voted 8-5 that the known and potential benefits of sabizabulin do not outweigh the known and potential risks.
Florida-based Veru's EUA submission was based on positive results from the double-blind placebo-controlled VERU-111 phase 3 clinical trial evaluating the efficacy and safety of sabizabulin — a first-in-class cytoskeleton disruptor that has dual anti-inflammatory and antiviral properties — in approximately 204 hospitalized COVID-19 patients with moderate to severe COVID at high risk for ARDS and death.
In a briefing doc released prior to the committee meeting, the FDA noted that "the VERU-111 program is quite small in size compared to other therapeutic programs for patients hospitalized with COVID-19," which meant that the available clinical information was "limited when compared to the typical efficacy and safety database available for other products that have been granted EUA."
Based on this concern, the agency highlighted a number of uncertainties with the data, including high placebo group mortality rate, baseline imbalances in standard of care therapies and differences in hospitalization duration prior to trial enrollment.
In its press release, Veru pointed out the possibility of an additional clinical trial as a potential post authorization requirement.
Prior to being developed for COVID-19, sabizabulin was shown in preclinical studies to have efficacy against many tumor types, including castration resistant prostate cancer, triple negative breast cancer, as well as ovarian cancer, cervical cancer, lung cancer, melanoma, leukemia, glioma and pancreatic cancer.
