Core Insights - Immunovant, Inc. (IMVT) shares increased by 10.8% following the announcement of six-month off-treatment results from a proof-of-concept study for batoclimab in patients with uncontrolled Graves' disease (GD) [1][4] - The study demonstrated that approximately 80% of patients maintained normalized thyroid hormone levels during the follow-up period, indicating strong durability of response [3][4] Study Details - The proof-of-concept study involved patients with active GD who had elevated thyroid hormone levels despite antithyroid drug (ATD) therapy. The primary endpoint was the normalization or reduction of thyroid hormone levels without increasing ATD dosage at week 24 [2] - Among the responders, about half achieved ATD-free remission, while 30% required only minimal ATD doses of 2.5 mg/day [6] Implications and Future Plans - The findings suggest that FcRn blockade may provide a promising therapeutic approach for GD, with potential for disease modification as several patients achieved durable remission after treatment withdrawal [7] - Immunovant plans to leverage the batoclimab data to expedite the development of its lead candidate, IMVT-1402, which is also aimed at treating GD [8] - The company has initiated two global studies for IMVT-1402, evaluating a 600 mg dose for up to 52 weeks, with top-line results expected in 2027 [9]

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 fo ...

Core Insights - Immunovant, Inc. presented six-month off-treatment data for batoclimab in uncontrolled Graves' disease patients, indicating potential disease modification and strong durability of response [1][2][3] Study Details - The proof-of-concept study involved a 24-week treatment with batoclimab, followed by a 24-week off-treatment follow-up, focusing on patients with active Graves' disease [3][4] - The key endpoint was the normalization of free triiodothyronine (T3) and free thyroxine (T4) levels without increasing anti-thyroid drug (ATD) doses from baseline [3] Remission Data - Out of 21 patients in the follow-up period, approximately 80% (17/21) maintained normal thyroid function at the end of six months [6][7] - Among the responders, about 50% (8/17) achieved ATD-free remission, while an additional 30% (5/17) were on low ATD doses [6][7] Future Trials - Two potentially registrational trials for Immunovant's lead compound IMVT-1402 in Graves' disease are currently enrolling, with topline readouts expected in 2027 [5][6]