NEW YORK, NY — Immunovant, Inc. (Nasdaq: IMVT), a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases, today shared an abstract with six-month off-treatment data in uncontrolled Graves’ disease (GD) patients treated with batoclimab for 24 weeks, to be presented at the 2025 Annual Meeting of the American Thyroid Association (ATA) on September 11, 2025.
“These novel and encouraging results support FcRn blockade as a potentially effective mechanism for the treatment of Graves’ disease, with the six-month remission data providing evidence of potential disease modification,” said George Kahaly, M.D., Ph.D., Lead Principal Investigator.
“We are incredibly excited to present these remission data demonstrating strong durability of response and ATD-free remission in previously uncontrolled patients off-treatment for six months,” said Eric Venker, M.D., Pharm.D., CEO of Immunovant. “We believe these data have the potential to be transformative for patients and practice-changing for physicians, if approved by FDA, by addressing a significant unmet need in Graves’ disease.”
Graves’ Disease Proof-of-Concept Study
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 (Weeks 0-12 at 680 mg weekly (QW) subcutaneously (SC) and Weeks 12-24 at 340 mg QW SC), 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 (TRAb) and hyperthyroid despite ATD therapy. The key endpoint of the study is the proportion of participants who achieve normalization of free triiodothyronine (T3) and free thyroxine (T4) or have T3 / T4 below the lower limit of normal (LLN) at Week 24, without an increase in ATD dose from baseline.
Graves’ Disease Six-month Remission Data
25 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 (patients off-treatment for 24 weeks), ~80% (17/21) patients maintained T3/T4 values ≤ upper limit of normal (ULN), indicating strong durability of response through six months off treatment
- Of these 17 patients, ~50% (8/17) were in ATD free-remission and an incremental ~30% (5/17) 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
IMVT-1402 Registrational Trial Design
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.
About Immunovant, Inc.
Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As a trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases. For additional information on the Company, please visit immunovant.com.
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