DURECT Announces Top-Line Results from Psoriasis Clinical Trial

DURECT announced the results from its Phase 2a clinical trial of DUR-928 in patients with mild to moderate plaque psoriasis. Twenty-two patients completed the study, applying DUR-928 topically to the plaque on one arm and the vehicle (placebo) to a similar plaque on the other arm daily for 28 days.

DUR-928 did not demonstrate a benefit over vehicle (placebo) based on Investigator's Global Assessment (IGA), which was the scoring system for the primary analysis, or in any of the secondary analyses. Daily topical application of DUR-928 was well tolerated with no meaningful differences in adverse events between the treatment and vehicle (placebo) groups. There were no AEs attributed to the study drug.

"Based on the top-line data, we do not plan to continue development of topical DUR-928 in psoriasis," said James E. Brown, President and CEO of DURECT. "With the recently announced positive results from our Phase 2a alcoholic hepatitis trial, our focus moving forward with DUR-928, will be on completing the NASH trial in the first half of this year and initiating the Phase 2b AH trial in the middle of the year."

The trial was a Phase 2a, randomized, double-blind, vehicle-controlled, multi-center, proof-of-concept study in which DUR-928 was applied topically once-daily for 28 days with a 28-day follow-up period in patients with mild to moderate plaque psoriasis. The trial was conducted in the U.S.  Each patient served as their own control, applying DUR-928 to the plaque on one arm and the vehicle (placebo) to a similar plaque on the other arm. After the treatment period, patients were followed for an additional four weeks.

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