Durect development timeline speeds up with BTD, says H.C. Wainwright

H.C. Wainwright maintains a Neutral rating on Durect after the FDA granted Breakthrough Therapy designation to larsucosterol for the treatment of severe alcohol-associated hepatitis. While larsucosterol did not reach statistical significance for either dose in both the primary and key secondary endpoints in the total study population, a subset analysis revealed that among patients who were enrolled in the U.S. who made up of 76% of all enrolled patients in AHFIRM, mortality reductions at 90 days were 57% in the 0 mg arm and 58% in the 90 mg arm compared to standard-of-care, the analyst tells investors in a research note. The firm says that while the Breakthrough Therapy designation provides multiple advantages to speed up larsucosterol’s development timeline, it awaits details of a single registrational Phase 3 trial of larsucosterol incorporating feedback from a Type C meeting with the FDA as the next major milestone.