Durect provides update on Pase 3 trial evaluating larsucosterol

DURECT provided details on the design of its upcoming registrational Phase 3 trial which will evaluate larsucosterol for the treatment of patients with severe alcohol-associated hepatitis, or AH. “We are pleased with the collaborative interactions with the FDA, including our recent Type B meeting held under Breakthrough Therapy designation, that allowed us to reach agreement on key elements of the protocol for the upcoming Phase 3 trial,” said James E. Brown, President and CEO of DURECT. “We believe the primary endpoint of 90-day survival is clinically meaningful and provides the greatest probability of success based on the AHFIRM data. In the completed AHFIRM trial, larsucosterol showed the ability to reduce mortality in AH patients compared to standard of care, particularly in the U.S., where we observed nearly 60% lower mortality at 90-days in both the 30 mg and 90 mg dose groups. We look forward to initiating the Phase 3 trial as soon as possible, subject to obtaining sufficient funds, which should enable us to report topline data within two years of trial initiation. The FDA also agreed that a single Phase 3 trial would be sufficient to support a New Drug Application. Larsucosterol’s Breakthrough Therapy designation for the treatment of AH gives us the opportunity to file an NDA as a rolling submission.” The proposed Phase 3 trial design incorporates feedback from the Type B meeting held with the FDA under the Breakthrough Therapy designation. It is designed as a randomized, double-blind, placebo-controlled, multi-center study conducted in the U.S., which will evaluate the safety and efficacy of larsucosterol for the treatment of patients with severe AH. The primary outcome measure will be a 90-day survival endpoint. The Phase 3 trial is planned to enroll approximately 200 patients randomized in a 1:1 ratio across two arms.