- Seeking to initiate Phase 3 registrational trial for larsucosterol with topline results expected within two years of initiation - Webcast of Earnings Call Today, November 13 at 4:30 p.m. ET CUPERTINO, Calif.
, Nov. 13, 2024 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX ) today announced financial results for the three months ended September 30, 2024 and provided a business update. "We remain focused on preparations for the Phase 3 trial for larsucosterol in severe alcohol-associated hepatitis (AH), including discussions with U.
S. clinical sites and hepatologists, to streamline the initiation process," stated James E. Brown , D.
V.M., President and CEO of DURECT.
"Our goal is to begin the trial as soon as possible, subject to obtaining sufficient funding, which should enable us to report topline data within two years of trial initiation. If successful, the FDA has agreed that a single Phase 3 trial may be sufficient to support a New Drug Application (NDA). We believe the selected primary endpoint of 90-day survival is clinically meaningful and provides the greatest probability of success based on the Phase 2b AHFIRM data.
We look forward to initiating the trial as soon as possible. We believe that larsucosterol, if approved, could provide physicians with a much-needed treatment that could significantly improve the current 90-day mortality rates of approximately 30%." Recent business highlights and updates: DURECT announced details on the design of its planned registrationa.
