Roivant Sciences(US:ROIV) Globenewswire·2025-09-17 11:00Core Insights - Roivant and Priovant Therapeutics announced positive results from the Phase 3 VALOR study for brepocitinib in treating dermatomyositis (DM) [1][2] Study Results - Brepocitinib 30 mg achieved a week 52 mean Total Improvement Score (TIS) of 46.5 compared to 31.2 for placebo, with a statistically significant p-value of 0.0006 [2][5] - This study marks the first positive outcome for a 52-week placebo-controlled trial in DM and the first positive registrational trial for a targeted therapy in DM [2][3] - Brepocitinib demonstrated clinically meaningful and statistically significant improvements across all nine key secondary endpoints [3][5] Patient Outcomes - Approximately 75% of patients entered the study on background steroids, with a mean baseline dose of 12.2 mg/day for the brepocitinib group and 11.3 mg/day for placebo [4] - 62% of brepocitinib 30 mg patients achieved a steroid dose of ≤2.5 mg/day by the end of the study, compared to 34% for placebo [4] - More than two-thirds of brepocitinib 30 mg patients experienced at least a moderate response (TIS≥40), and nearly half experienced a major response (TIS≥60) [5][6] Safety Profile - The safety profile of brepocitinib 30 mg was consistent with previous clinical trials, with no increased frequency of adverse events of special interest compared to placebo [5][7] - The median time to a TIS≥40 response was approximately 8 weeks, indicating a rapid onset of clinical improvement [6] Future Plans - An NDA filing for brepocitinib in dermatomyositis is planned for the first half of 2026 [5][8] - Roivant will host an investor call to discuss these updates on September 17, 2025 [11] Background Information - Dermatomyositis is a debilitating autoimmune disease affecting approximately 50,000 adults in the U.S., characterized by muscle weakness and skin lesions [9] - The VALOR study is noted as the longest and largest interventional DM study ever conducted, enrolling 241 subjects globally [10]