DURECT Reaches Enrollment Milestone in Phase 2b AHFIRM Trial

• AHFIRM enrollment surpasses 200 of the planned 300 AH patients
• Enrollment completion now anticipated in Q2 2023

Excerpt from the Press Release:

CUPERTINO, Calif., Oct. 6, 2022 /PRNewswire/ — DURECT Corporation (Nasdaq: DRRX), a biopharmaceutical company focused on developing epigenetic regulator programs for the treatment of acute organ injury and chronic liver diseases, today announced the enrollment of more than 200 of the planned 300 patients in its Phase 2b AHFIRM trial. The AHFIRM trial seeks to evaluate larsucosterol’s potential to serve as a treatment for severe alcohol-associated hepatitis (AH).

“We are very pleased to reach this enrollment milestone in our AHFIRM trial,” said James E. Brown, D.V.M., President and CEO of DURECT. “We are proud that the DURECT team continues to drive this important clinical trial forward, and with their hard work and dedication we are now on track to complete enrollment in the second quarter of 2023. We look forward to reading out our topline results in the second half of 2023 and moving closer to attaining our goal of bringing larsucosterol to AH patients as the first approved treatment for this deadly disease.”

About the AHFIRM Trial

Enrollment is ongoing in our Phase 2b randomized, double-blind, placebo-controlled, international, multi-center study in subjects with severe alcohol-associated hepatitis (AH) to evaluate saFety and effIcacy of laRsucosterol (DUR-928) treatMent (AHFIRM). The study is comprised of three arms targeting enrollment of 300 total patients, with approximately 100 patients in each arm: (1) Placebo plus supportive care, with or without methylprednisolone capsules at the investigators’ discretion; (2) larsucosterol (30 mg); and (3) larsucosterol (90 mg).

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