Two months after regulators denied Veru a bid for an emergency use authorisation in Covid-19, the drug company plans to show its previous Phase III success was no fluke.
On May 4, Veru announced that the US Food and Drug Administration (FDA) provided positive feedback on a newly proposed Phase III trial testing sabizabulin in 408 patients with moderate to severe Covid-19. Veru plans to initiate the trial in the second half of 2023.
Previously, the FDA elected not to issue an emergency use authorisation for sabizabulin based on a 210-patient Phase III study in Covid-19 (NCT04842747). Though the trial met its primary endpoint of reducing all-cause mortality, regulators had expressed concerns over the strength of the data.
In an FDA Advisory Committee meeting on November 9, 2022, a panel of outside experts voted eight-to-five against an emergency use authorisation for sabizabulin. During the meeting, experts questioned the small study size, baseline imbalances between the treatment and placebo groups, and an abnormally high mortality rate in the placebo arm.
But with a new Phase III trial in the works, Veru hopes to correct course as it looks toward an FDA emergency use authorisation, or even full approval, in Covid-19.
Veru’s Phase III study of sabizabulin
As a primary endpoint, Veru’s news Phase III trial will test all-cause mortality. The study will enroll patients with moderate-to-severe Covid-19 who are at high risk for acute respiratory distress syndrome (ARDS) regardless of the presence of comorbidities.
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The study includes two pre-planned interim analyses, the first of which is planned for 2024. Secondary endpoints will include days in the hospital, days on mechanical ventilation, and the proportion of patients alive without respiratory failure, among others.
Even as the Covid-19 pandemic begins shifting toward an endemic phase, trials like Veru’s sabizabulin study continue to dominate the infectious disease drug development landscape.