Immunovant: 80% of patients demonstrate response in Graves’ disease trial

Immunovant (IMVT) shared an abstract with six-month off-treatment data in uncontrolled Graves’ disease patients treated with batoclimab for 24 weeks, to be presented at the 2025 Annual Meeting of the American Thyroid Association on September 11, 2025. Six-month off-treatment data was generated from a proof-of-concept study of batoclimab in Graves’ disease. Batoclimab is Immunovant’s first generation fully human monoclonal antibody targeting FcRn. The study included a 24-week treatment period with a dose step-down, followed by a 24-week off-treatment follow-up period. The study included patients with active Graves’ disease as documented by presence of elevated thyrotropin receptor autoantibodies and hyperthyroid despite ATD therapy. The key endpoint of the study is the proportion of participants who achieve normalization of free triiodothyronine and free thyroxine or have T3 / T4 below the lower limit of normal at Week 24, without an increase in ATD dose from baseline. patients were enrolled in the treatment period with 21 patients entering the off-treatment 24-week follow-up period to be assessed for remission: At Week 48, or the end of the six-month follow-up period, ~80% patients maintained T3/T4 values less than or equal to upper limit of normal, indicating strong durability of response through six months off treatment; Of these 17 patients, ~50% were in ATD free-remission and an incremental ~30% were on ATD doses of 2.5 mg/day following six months off treatment, even with batoclimab’s suboptimal step-down dosing design during the treatment period; Safety and tolerability were observed to be consistent with prior batoclimab studies. Two potentially registrational trials of Immunovant’s lead compound IMVT-1402 in Graves’ disease will evaluate 600 mg dose for up to 52 weeks without a step-down in dose. The two potentially registrational global trials for IMVT-1402 in Graves’ disease are currently enrolling with topline readouts expected in 2027.