DURECT Announces Phase 3 Registrational Trial Design For Larsucosterol In Alcohol-Associated Hepatitis; Type B Meeting With FDA Held Under Breakthrough Therapy Designatoin Resulted In Agreement On Aspects Of Phase 3 Design, Says 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
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DURECT has announced the design for a Phase 3 trial of Larsucosterol in treating alcohol-associated hepatitis. The trial, agreed upon with the FDA, will enroll 200 U.S. patients and focus on a 90-day survival endpoint. Results are expected within two years.
September 25, 2024 | 12:02 pm
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DURECT's Phase 3 trial design for Larsucosterol in alcohol-associated hepatitis has been agreed upon with the FDA. The trial will enroll 200 U.S. patients with a primary endpoint of 90-day survival, and results are expected within two years.
The announcement of a Phase 3 trial design, especially with FDA agreement, is a significant milestone for DURECT. It indicates progress in drug development, which is likely to positively impact investor sentiment and the stock price in the short term.
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