Immunovant, Inc. today announced encouraging six-month off-treatment data from a proof-of-concept study of batoclimab in uncontrolled Graves’ disease (GD) patients. These results are slated for presentation at the 2025 Annual Meeting of the American Thyroid Association (ATA) on September 11, 2025. The study involved a 24-week treatment period followed by a 24-week off-treatment follow-up, assessing patients with active GD who remained hyperthyroid despite antithyroid drug (ATD) therapy.
The data revealed that 17 of the 21 patients who entered the off-treatment follow-up period maintained normal thyroid function six months after completing treatment. Furthermore, 8 of these 17 patients, representing 47% of those who maintained normal function, did not require anti-thyroid drugs to keep their hormone levels in check. These findings suggest strong durability of response and potential for disease modification through FcRn blockade.
These positive results for batoclimab in Graves' disease provide strong mechanistic support for Immunovant's lead compound, IMVT-1402. Two potentially registrational global trials for IMVT-1402 in Graves’ disease are currently enrolling, evaluating a 600 mg dose for up to 52 weeks, with topline readouts expected in 2027. The data from batoclimab are expected to inform and de-risk the ongoing IMVT-1402 program.
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