Durect corporation announces phase 3 registrational trial design for larsucosterol in alcohol-associated hepatitis

- type b meeting with fda held under breakthrough therapy designation resulted in agreement on key aspects of phase 3 trial design - 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  - protocol for phase 3 trial builds on data from the ahfirm phase 2b trial; 30 mg and 90 mg doses of larsucosterol reduced 90-day mortality in u.s. patients by 57% and 58%, respectively, compared with placebo cupertino, calif. , sept. 25, 2024 /prnewswire/ -- durect corporation (nasdaq: drrx), a late-stage biopharmaceutical company pioneering the development of epigenetic therapies to transform the treatment of serious and life-threatening conditions such as acute organ injury, today provided details on the design of its upcoming registrational phase 3 trial which will evaluate larsucosterol for the treatment of patients with severe alcohol-associated hepatitis (ah).
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