Roivant Announces Expansion of Brepocitinib Development Program with New Phase 2b/3 Trial in Lichen Planopilaris (LPP) and Phase 3 Study Results for Batoclimab in Thyroid Eye Disease (TED)

Core Insights - Roivant announced a new Phase 2b/3 clinical program for brepocitinib targeting lichen planopilaris (LPP), a severe inflammatory scalp disorder affecting around 100,000 adults in the U.S. [1] - The company reported topline results from Immunovant's Phase 3 studies evaluating batoclimab for thyroid eye disease (TED) [1] Brepocitinib in LPP - LPP causes irreversible hair loss and scarring, with symptoms including pain, burning, itching, and an increased risk of comorbidities like autoimmune diseases and skin cancers [2][6] - There are currently no FDA-approved treatments for LPP, indicating a significant unmet medical need [6] - The seamless Phase 2b/3 study of brepocitinib began enrolling subjects in March 2026, marking the fourth indication in its late-stage development program [3][6] - The FDA granted Priority Review for brepocitinib's New Drug Application for dermatomyositis (DM), with a target action date in Q3 2026 [3] Immunovant Phase 3 Studies in TED - Immunovant's Phase 3 studies of batoclimab in TED did not meet their primary endpoint of ≥2mm proptosis responder rate at Week 24 [7] - Safety results were consistent with previous findings, with no new safety signals identified [7] - Patients showed greater proptosis improvement after the initial high-dose period compared to the low-dose period, indicating the benefits of deeper IgG suppression [8] Future Development Plans - Immunovant is focused on advancing IMVT-1402, an investigational FcRn blocker, across multiple autoimmune diseases, with Graves' disease as a strategic priority [9] - Topline data from registrational studies of IMVT-1402 in Graves' disease are expected in 2027 [9] - Future plans for batoclimab development will be reviewed with partner HanAll Biopharma Co., Ltd. [10]