Immunovant’s FcRn inhibitor batoclimab failed to meet primary endpoints in two Phase 3 trials for thyroid eye disease, according to disclosures from Roivant and the company’s partner. The studies did not demonstrate the prespecified level of proptosis reduction after dosing regimens that included high-dose suppression followed by low-dose maintenance. Roivant said no new safety signals emerged and emphasized that deeper IgG suppression during the high-dose phase correlated with greater proptosis improvements. The failure adds to a pattern of difficult approvals for FcRn inhibitors in ocular autoimmunity and sets up a review of future plans with partner HanAll.
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