Benzinga | Sep 22, 2020 08:37AM EDT

DURECT Corporation Announces Design Of Phase 2b AHFIRM AH Study

CUPERTINO, Calif., Sept. 22, 2020 /PRNewswire/ --DURECT Corporation (NASDAQ:DRRX) today announced the study design for the Phase 2b AHFIRM clinical trial of DUR-928 in severe alcoholic hepatitis (AH) patients.

AHFIRM is a randomized, double-blind, placebo-controlled, international, multi-center Phase 2b study to evaluate the safety and efficacy of DUR-928 in approximately 300 patients with severe AH. The study will be comprised of three arms of approximately 100 patients each: (1) DUR-928 (30 mg); (2) DUR-928 (90 mg); and (3) Placebo plus standard of care (SOC). SOC may include the use of methylprednisolone, a corticosteroid, at the discretion of the treating physician. Patients will receive an intravenous (IV) dose of DUR-928 or placebo (sterile water) on day 1 and a second IV dose on day 4 if they are still hospitalized. The primary outcome measure will be 90-day survival rate for patients treated with DUR-928 compared to those treated with placebo plus SOC. Secondary endpoints include 28-day survival, the rate of adverse events, Lille and MELD (prognostic scores) and time in the intensive care unit. The Company is targeting 40-45 clinical trial sites in the US and Europe and anticipates trial initiation in October.

"We are pleased to announce the design and pending initiation of this important clinical trial," stated James E. Brown, D.V.M., President and CEO of DURECT. "Following on the very encouraging results from our Phase 2a AH trial, we believe that the Phase 2b AHFIRM trial will provide a robust evaluation of the safety and potential life-saving capacity of DUR-928 in severe AH patients, who desperately need an effective therapy."