NEWS
DURECT Corporation Announces Phase 3 Registrational Trial Design for Larsucosterol in Alcohol-associated Hepatitis
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 initiation
- Protocol for Phase 3 trial builds on data from the AHFIRM Phase 2b trial; 30 mg and 90 mg doses of larsucosterol reduced 90-day mortality in U.S. patients by 57% and 58%, respectively, compared with placebo
CUPERTINO, Calif. , Sept. 25, 2024 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX), a late-stage biopharmaceutical company pioneering the development of epigenetic therapies to transform the treatment of serious and life-threatening conditions such as acute organ injury, today 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 (AH).
- 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 initiation
- Protocol for Phase 3 trial builds on data from the AHFIRM Phase 2b trial; 30 mg and 90 mg doses of larsucosterol reduced 90-day mortality in U.S. patients by 57% and 58%, respectively, compared with placebo
CUPERTINO, Calif. , Sept. 25, 2024 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX), a late-stage biopharmaceutical company pioneering the development of epigenetic therapies to transform the treatment of serious and life-threatening conditions such as acute organ injury, today 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 (AH).
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