Priovant Therapeutics, a company established in 2021 as part of a transaction between Pfizer (PFE) and Roivant Sciences (ROIV), announced positive mid-stage trial results for its lead asset, brepocitinib, in cutaneous sarcoidosis, a skin disorder with no FDA-approved therapies.
Citing data from its Phase 2 BEACON trial, which enrolled 31 CS patients in the U.S., Priovant said that following a 16-week treatment period, brepocitinib at 45 mg improved cutaneous sarcoidosis disease activity with a statistically significant effect compared to placebo.
All CS patients in the 45 mg arm indicated at least a 10-point improvement in a clinical measure called the Cutaneous Sarcoidosis Activity and Morphology Instrument – Activity Score compared to 14% on placebo.
The Durham, NC-based biotech added that brepocitinib showed a well-tolerated safety profile with all adverse events being mild or moderate in severity. According to the company, there were no serious adverse events.
Priovant, in which Pfizer (PFE) holds a 25% stake, plans to seek FDA feedback on the results and begin a Phase 3 program for the once-daily oral therapy in CS this year.