Immunovant reports positive Phase II batoclimab data as IMVT-1402 advances

Graves’ disease is an autoimmune disorder that causes the thyroid gland to become overactive. This thyroid condition results in high levels of thyroid hormones, triiodothyronine (T3) and thyroxine (T4). The primary treatment for Graves’ hyperthyroidism involves antithyroid drugs (ATDs).

Immunovant, a company specializing in immunology, recently announced positive outcomes from a clinical trial examining its monoclonal antibody drug, batoclimab, for patients with Graves’ disease. According to CEO Pete Salzmann, the trial demonstrated "strong response rates" after patients received injections of batoclimab. Additionally, Immunovant is preparing for a pivotal trial of another autoimmune candidate, IMVT-1402, which is set to commence later this year following the approval of an investigational new drug application by the U.S. Food and Drug Administration.

Batoclimab has been under investigation in a Phase IIa trial involving patients with Graves’ disease who remained hypothyroid despite undergoing antithyroid therapy. The trial was marked as NCT05907668. During a 12-week course of high-dose batoclimab (680 mg administered weekly), patients experienced an average 77% reduction in immunoglobulin-G (IgG) levels. This led to a 76% response rate, defined by T3 and T4 hormone levels dropping below the upper limit of normal (ULN) without the need to increase the ATD dose.

The primary goal of the trial is to assess the percentage of participants who achieve normalization or reduction of T3 and T4 levels below the lower limit of normal (LLN) after 24 weeks. Although specific details on this measurement have not been disclosed, the promising results of batoclimab’s efficacy are evident. Its higher-dose version achieved a 56% ATD-Free Response, indicating that T3 and T4 levels fell below the ULN while patients were able to completely taper off their ATD.

Salzmann highlighted the impressive correlation between clinical response and IgG lowering, suggesting that this offers a potential first-in-class and best-in-class opportunity for IMVT-1402. He also mentioned that the company has reached an agreement with the FDA on the design of the pivotal trial, which is expected to begin by the end of the year.

In the broader strategy, Immunovant has decided to prioritize IMVT-1402 for treating myasthenia gravis (MG), a disorder causing muscle weakness, over batoclimab. Batoclimab is currently being evaluated in a Phase III trial for MG. Immunovant is optimistic that IMVT-1402 may demonstrate superior efficacy, though confirmation will await the topline results from the Phase III trial, anticipated in early 2025.

Beyond Graves' disease, batoclimab is also being explored for its potential in treating other conditions, such as thyroid eye disease and chronic inflammatory demyelinating polyneuropathy (CIDP).

Immunovant’s progress with batoclimab and forthcoming trials for IMVT-1402 signify a strong commitment to addressing complex autoimmune disorders, promising new hope for patients who have limited treatment options.