Roivant: Oral Brepocitinib Fails To Meet Primary Endpoint In Phase 2 Study

(RTTNews) - Roivant (ROIV) and Priovant announced the Phase 2 study evaluating oral brepocitinib in adult patients with moderate to severe active lupus did not meet its primary endpoint of Systemic Lupus Erythematosus Responder Index change of 4 at Week 52.

"While we do not plan to progress the program in Systemic Lupus Erythematosus, these results continue to support our view that oral brepocitinib is a highly active agent with a good safety profile, and we remain enthusiastic about brepocitinib's ability to produce meaningful clinical benefit in non-infectious uveitis and dermatomyositis in Priovant's ongoing trials, as well as in many other potential indications" said Matt Gline, CEO of Roivant.

Priovant expects to announce topline results from its own studies, the Phase 2 POC study of brepocitinib in non-infectious uveitis in the first quarter of calendar year 2024 and the Phase 3 trial in dermatomyositis in calendar year 2025.

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