Roivant Sciences Ltd (NASDAQ:ROIV) and Priovant Therapeutics released results from the Phase 3 VALOR study evaluating brepocitinib in dermatomyositis (DM).
Dermatomyositis is a chronic autoimmune disorder causing muscle inflammation and a distinctive skin rash, often purple or reddish, on areas like the face, knuckles, and upper chest.
Once-daily oral brepocitinib 30 mg demonstrated clinically meaningful and statistically significant improvement compared to placebo on the primary endpoint and all nine key secondary endpoints, including measurements of skin disease, muscle disease, steroid-sparing effect, and rapidity of onset.
On the primary endpoint, brepocitinib 30 mg achieved a week 52 mean Total Improvement Score (TIS) of 46.5 compared to 31.2 for placebo (p=0.0006).
A statistically significant difference between brepocitinib 30 mg and placebo on mean TIS was seen at all time points, including as early as week 4.
The result represents the first-ever positive outcome for a 52-week placebo-controlled trial in dermatomyositis and the first-ever positive registrational trial for a targeted therapy in dermatomyositis.
Brepocitinib also demonstrated clinically meaningful and statistically significant improvement over placebo on all nine key secondary endpoints.
A dose-dependent response was observed between brepocitinib 30 mg and brepocitinib 15 mg across both primary and secondary endpoints.
Approximately 75% of patients entered the VALOR study on background steroids, with a mean baseline dose of 12.2 mg/day in the brepocitinib 30 mg arm and 11.3 mg/day in the placebo arm.
Of these patients on background steroids, 62% of brepocitinib 30 mg patients achieved a steroid dose ≤2.5 mg/day by the end of the study (compared to 34% for placebo), and 42% of brepocitinib 30 mg patients were able to come off steroids altogether (compared to 23% for placebo).
The observed brepocitinib 30 mg safety profile was consistent with previous brepocitinib clinical trials.
Priovant plans to file an NDA for brepocitinib in dermatomyositis in the first half of 2026.
Price Action: ROIV stock is up 11.11% at $15.76 at the last check on Wednesday.
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