- FDA Granted Breakthrough Therapy Designation for Larsucosterol in Alcohol-Associated Hepatitis - Held Type B Meeting with FDA to Discuss Phase 3 Clinical Trial Design - Seeking to Initiate Phase 3 Trial in 2024 with Topline Results Expected in 2H 2026 - Webcast of Earnings Call Today, August 13th at 4:30 p.m. ET CUPERTINO, Calif.
, Aug. 13, 2024 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX ) today announced financial results for the three months ended June 30, 2024 and provided a business update. "Our immediate priority is to finalize the design of our planned pivotal Phase 3 trial of larsucosterol in alcohol-associated hepatitis (AH)," stated James E.
Brown , D.V.M.
, President and CEO of DURECT. "Recently we had a productive Type B meeting with the U.S.
Food and Drug Administration (FDA) to discuss our proposed trial design and requirements to obtain approval. We are encouraged by the FDA's feedback on our plans to advance development of larsucosterol, including its granting of Breakthrough Therapy Designation (BTD), and look forward to providing a further update on specifics of the Phase 3 design following expected communications from FDA. Assuming we obtain sufficient funds, we plan to initiate the Phase 3 study by the end of 2024 and would expect to report topline results by the second half of 2026.
We are committed to advancing development of larsucosterol and bringing this potentially lifesaving therapy to patients as quickly as possible. If larsucosterol meets ou.