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
Portfolio Pulse from Benzinga Newsdesk
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
News sentiment analysis
Sort by:
Ascending
POSITIVE IMPACT
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.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100