Shares of Roivant Sciences (NASDAQ:ROIV) climbed 9% after the company, together with partner Priovant Therapeutics, reported encouraging Phase 3 results for brepocitinib in patients with dermatomyositis, a rare autoimmune disorder.
The once-daily oral brepocitinib 30 mg showed statistically significant and clinically meaningful improvements versus placebo across the primary endpoint and all nine key secondary endpoints. For 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).
“This study marks the first-ever positive outcome from a 52-week, placebo-controlled trial in dermatomyositis and the first positive registrational trial for a targeted therapy in this condition,” the company noted. Differences between brepocitinib 30 mg and placebo were evident as early as week 4 and persisted throughout the 52-week trial.
Over two-thirds of patients receiving the 30 mg dose experienced at least a moderate response, with nearly half showing a major response. The therapy also demonstrated a robust steroid-sparing effect: 42% of patients on brepocitinib were able to discontinue steroids entirely, compared with 23% in the placebo group.
Safety results were consistent with prior brepocitinib studies, with no increase in adverse events of special interest—such as malignancies, cardiovascular, or thromboembolic events—in the treatment arm compared to placebo.
Priovant plans to submit a New Drug Application (NDA) for brepocitinib in dermatomyositis during the first half of 2026.
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