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Roivant's Brepocitinib Phase 3 Dermatomyositis Trial Hits Primary and All Key Secondary Endpoints [Yahoo! Finance]

Roivant Sciences Ltd. (ROIV) 
Company Research Source: Yahoo! Finance
announced positive results from the Phase 3 VALOR study, a 52-week placebo-controlled trial evaluating the once-daily oral drug brepocitinib in patients with dermatomyositis/DM. This trial enrolled 241 subjects globally and is noted as the longest and largest interventional DM study ever conducted. The study met its primary endpoint, with the brepocitinib 30 mg dose achieving a week 52 mean Total Improvement Score/TIS of 46.5, compared to 31.2 for placebo. A statistically significant difference in mean TIS between the 30 mg dose and placebo was observed as early as week 4 and was sustained throughout the one-year study. Roivant's Brepocitinib Phase 3 Dermatomyositis Trial Hits Primary and All Key Secondary Endpoints This result marks the first-ever positive outcome for a 52-week placebo-controlled trial and the first positive registrational trial for a targeted therapy in DM. Brepocitinib 30 mg also demonstrated clinically meaningful and statistically significant improvement ove Show less Read more
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