FDA Reschedules Advisory Committee Meeting for COVID-19 Treatment

Veru is seeking an emergency use authorization for sabizabulin, a first-in-class treatment for hospitalized COVID-19 patients at high risk for acute respiratory distress syndrome. The advisory committee meeting is now Nov. 9, 2022.

The FDA has rescheduled the FDA’s Pulmonary-Allergy Drugs Advisory Committee to discuss the Veru’s sabizabulin for hospitalized COVID-19 patients who are at high risk for acute respiratory distress syndrome (ARDS). The meeting has been rescheduled to Nov. 9, 2022. The meeting had originally been scheduled for Oct. 6, 2022.

Sabizabulin (VERU-111) is a first-in-class microtubule disruptor that has dual anti-inflammatory and antiviral properties. Microtubule trafficking is critical for viruses to cause infection.

The application, which Veru submitted in June, is based on data from the phase 3 COVID-19 trial results evaluating the efficacy and safety of oral sabizabulin. Results were published in The New England Journal of Medicine Evidence. The trial was conducted in 204 hospitalized COVID-19 patients with moderate-to-severe COVID-19 who were at high risk for ARDS and death. The primary endpoint was the proportion of deaths by day 60.

Based on a planned interim analysis of the first 150 patients randomized, the independent data monitoring committee halted the study because it showed clinical efficacy and no safety concerns. Treatment with sabizabiln resulted in a clinically meaningful and statistically significant 55.2% relative reduction in deaths compared with placebo in the intent-to-treat population.

Sabizabulin treatment also resulted in a 43% relative reduction in days in ICU, 49% relative reduction in days on mechanical ventilation, and 26% relative reduction in days in hospital vs. placebo. The proportion of patients with an adverse event or a serious adverse event was lower in the sabizabulin compared with the placebo group.

“The results of this phase 3 trial confirm the earlier phase 2 data affirming the value of sabizabulin in hospitalized patients with moderate-to-severe COVID-19 infection. It is exciting to have another option to address this difficult to treat population,” one of the lead investigators Michael Gordon, M.D., chief medical officer, HonorHealth Research and Innovation Institute, said in an August press release.