Immunovant, Inc. (IMVT), a member of the Roivant Sciences Ltd. (ROIV) family of companies, has announced promising results from its Phase 2a trial of batoclimab in treating Graves’ Disease. This autoimmune condition affects the thyroid gland, causing the body to produce excessive thyroid hormone.
The trial enrolled patients with Graves’ Disease who remained hyperthyroid despite treatment with antithyroid drugs (ATDs). Participants received 12 weeks of high-dose batoclimab followed by 12 weeks of lower-dose batoclimab. After the initial 12 weeks, the patients experienced an average IgG reduction of 77%, resulting in a 76% response rate. Notably, 56% of patients achieved an ATD-Free Response at the end of this period.
While the lower dose of batoclimab also led to IgG reduction and a response rate, the results were slightly less pronounced compared to the high-dose treatment. This suggests that the higher dose may be more effective in achieving a sustained response.
Interestingly, patients who achieved at least a 70% IgG reduction at the end of the trial showed a significantly higher ATD-Free Response rate (60%) compared to those with lower IgG reduction (23%). This correlation between clinical response and IgG lowering supports the potential of batoclimab as a first-in-class and potentially best-in-class treatment for Graves’ Disease.
Encouraged by the positive results, Immunovant has aligned with the FDA and received Investigational New Drug Application clearance. This allows the company to proceed with a pivotal trial of batoclimab for Graves’ Disease, which is expected to start by December 31, 2024.
“We find the correlation between clinical response and IgG lowering impressive and believe this creates not only a potential first-in-class but also a potential best-in-class opportunity for IMVT-1402. We are very pleased to have aligned with the FDA on a pivotal trial design that we expect to initiate by the end of the year,” stated Pete Salzmann, CEO of Immunovant.
The stock market responded positively to the news, with ROIV shares increasing by 4.67% and IMVT shares slightly declining by 0.32% at the end of the trading day. These findings hold significant promise for patients with Graves’ Disease and indicate a potential breakthrough in treatment options for this condition.
