Business
Immunovant Unveils Durability and Treatment-Free Six-month Remission Data with Potential to Change Treatment Paradigm for Uncontrolled Graves' Disease Patients
First-ever potentially disease-modifying therapy for uncontrolled Graves’ disease patientsOf 21 patients who entered the six-month off-treatment follow-up
About this update from Immunovant, Inc.
[{"type":"text","content":"First-ever potentially disease-modifying therapy for uncontrolled Graves’ disease patientsOf 21 patients who entered the six-month off-treatment follow-up period, ~80% (17/21) demonstrated response, resulting in normal thyroid function (T3 and T4 less than the upper limit of normal) at the end of the six-month follow-up periodOf the 17 responders to therapy, ~50% (8/17) achieved anti-thyroid drug (ATD) free remission at six months following end of batoclimab treatmentTwo potentially registrational trials for IMVT-1402 in Graves’ disease are currently enrolling with topline readouts expected in 2027Roivant to host investor call to discuss these updates today, September 3, 2025, at 4:30 p.m. EDT NEW YORK, Sept. 03, 2025 (GLOBE NEWSWIRE) -- 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 a...