Immunovant reported that its experimental therapy batoclimab did not meet the primary endpoint in two phase 3 trials involving patients with moderate-to-severe thyroid eye disease (TED), based on results disclosed by its majority shareholder, Roivant.
The late-stage studies, which were first outlined in 2022, assessed batoclimab in individuals diagnosed with TED, an autoimmune condition associated with eye bulging, also known as proptosis. In both trials, patients were randomized to receive either batoclimab or a placebo. The dosing schedule included an initial 12-week period of high-dose treatment followed by an additional 12 weeks at a lower dose. The main goal of the studies was to demonstrate a reduction of at least 2 millimeters in proptosis after the full 24-week treatment duration.
According to Roivant, neither study achieved this primary objective. However, the company stated that greater reductions in proptosis were observed during the high-dose phase when compared to the subsequent low-dose period. Roivant said this observation supports the benefit of deeper immunoglobulin G (IgG) suppression, noting that TED is an IgG-mediated autoimmune disease.
The safety profile observed in the trials remained consistent with earlier findings, and no new safety signals were reported. In addition to the primary endpoint results, Roivant highlighted findings from a subgroup of hyperthyroid patients. In these individuals, batoclimab demonstrated thyroid hormone normalization rates similar to those previously reported in a phase 2 study conducted in Graves’ disease, a condition that can lead to TED.
Batoclimab is designed to help the body eliminate harmful antibodies by blocking a protein that normally keeps them circulating in the bloodstream. The therapy previously recorded a phase 3 success in myasthenia gravis in March 2025. Despite that outcome, Immunovant had already decided not to commercialize batoclimab for that indication. At the time, the company had indicated it would wait for the results of the TED studies before determining whether to proceed further with development in this area.
Following the release of the phase 3 data, the company indicated that batoclimab is not a key focus for TED going forward. Matt Gline, CEO of Roivant, stated, “The results do not support further progress in thyroid eye disease.” Immunovant also said it plans to review future development options for batoclimab in collaboration with its partner, HanAll Biopharma, and will provide an update at a later date.
TED can result in abnormal enlargement of the muscles that control eye movement as well as the fat located behind the eye, and it may also involve orbital inflammation. These changes can lead to proptosis, double vision, and, in more severe cases, vision loss.
The outcome of these studies follows other challenges in the development of FcRn inhibitors for TED. argenx had previously discontinued studies of its therapy Vyvgart for the same condition after the trials appeared unlikely to meet their objective.
Immunovant is now focusing its development efforts on its second-generation FcRn inhibitor, IMVT-1402. Roivant confirmed that topline data from phase 2b studies of IMVT-1402 in Graves’ disease are expected next year.
Separately, Viridian Therapeutics reported that its experimental treatment for thyroid eye disease lagged rivals in efficacy in a late-stage study. Following the announcement of Immunovant’s results, the company’s shares declined by 4.8% to $23.89.
What Happened in the Batoclimab Trials?
Batoclimab was evaluated in two late-stage trials targeting moderate-to-severe thyroid eye disease. The primary goal of Batoclimab treatment was to reduce eye bulging (proptosis), a key symptom of the disease.
However, Batoclimab failed to achieve the required efficacy benchmark, specifically missing the target of at least a 2 mm reduction in eye bulging after 24 weeks of treatment.
Understanding Batoclimab’s Mechanism
Batoclimab is designed as an FcRn inhibitor that reduces harmful IgG antibodies in the body. By lowering these antibodies, Batoclimab aims to control autoimmune responses associated with thyroid eye disease.
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