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DURECT Corporation Announces Phase 3 Registrational Trial Design for Larsucosterol in Alcohol-associated Hepatitis

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Sep 25, 2024, 5:00 AM PDT

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– Type B meeting with FDA held under Breakthrough Therapy designation resulted in agreement on key aspects of Phase 3 trial design – Single Phase 3 trial designed to enroll 200 U.S. patients with a 90-day survival primary endpoint; topline results expected within two years of trial…