Immunovant Reports Positive Initial Phase 2 Results for Batoclimab in Graves’ Disease

NEW YORK, Dec. 20, 2023 (GLOBE NEWSWIRE) -- Immunovant, Inc. (Nasdaq: IMVT), a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases, today announced that results from the initial cohort of patients in an ongoing 24-week Phase 2 clinical trial of batoclimab in patients with Graves’ disease meaningfully exceeded 50% response rates.

This Phase 2 proof-of-concept trial is an open-label study to assess the safety and efficacy of batoclimab in Graves’ disease. Patients who are hyperthyroid despite treatment with an anti-thyroid medication (ATD) for more than 12 weeks are being enrolled to receive once-weekly subcutaneous (SC) injections of 680 mg batoclimab for 12 weeks followed by once-weekly SC injections of 340 mg batoclimab for 12 weeks. Treatment response is defined as normalization of T3 and T4 hormone levels without increasing ATD dose. The primary and secondary outcome measurements of the trial are being measured at weeks 12 and 24. This design allowed for efficacy assessments between two distinct ranges of IgG reductions.

Consistent with studies of batoclimab in other indications, 680 mg administered SC in the initial cohort demonstrated potential best-in class IgG reduction, up to 87%, with a mean IgG reduction of 81% after 12 weeks of treatment. The 340 mg IgG reductions were lower.   A similar dose response was observed for anti-TSHR autoantibodies, with deeper reductions observed following treatment with 680 mg of SC batoclimab as compared to 340 mg of SC batoclimab. In addition, across a range of clinical parameters, numerically higher responses were observed following treatment with 680 mg of batoclimab as compared to treatment with 340 mg of batoclimab. These parameters included the percentage of patients whose ATD dose was reduced and the percentage of patients whose ATD was discontinued.  Batoclimab was generally well tolerated with no new safety signals observed in the initial data set. 

“We believe the enrolled population is unlikely to spontaneously remit and therefore a greater than 50% response rate is encouraging,” said Pete Salzmann, M.D., chief executive officer at Immunovant.  “While preliminary, these data suggest there is a dose response on efficacy between a regimen that produces 60-70% IgG reductions, such as 340 mg of batoclimab, and a regimen that produces 80% IgG reductions. We are excited to have what we believe to be the only option across the anti-FcRn field of a simple SC injection to produce this profile. We believe there is a high unmet need in second line Graves’ disease and are enthusiastic about the addressable market size here. While this trial is ongoing, we intend to focus our future development in Graves’ on IMVT-1402, with plans expected to be announced later in 2024.”