Roivant (NASDAQ:ROIV) and its Pfizer (NYSE:PFE)-backed joint venture Priovant Therapeutics announced on Wednesday that their experimental therapy brepocitinib for an inflammatory condition known as dermatomyositis reached the primary endpoint in a Phase 3 trial.
Citing 52-week data from their VALOR study, the companies said that the once-daily oral therapy at a 30 mg dose achieved the primary endpoint related to mean Total Improvement Score (TIS), a clinical scale used to measure dermatomyositis activity.
The difference between brepocitinib 30 mg and placebo in terms of mean TIS was statistically significant at all-time points, noted Roivant (NASDAQ:ROIV) and Priovant, which was launched in 2022 with a 25% equity stake from Pfizer (NYSE:PFE).
The global trial of 241 subjects evaluated 30 mg and 15 mg of brepocitinib against placebo over a one-year double-blind period.
Regarding tolerability, the companies noted that brepocitinib 30 mg indicated a safety profile consistent with its previous clinical trials, and the frequency of notable adverse events, including malignancy and cardiovascular events, was not higher in the brepocitinib 30 mg arm compared to the placebo arm.
Priovant expects to seek the U.S. FDA’s approval for brepocitinib in H1 2026.