Shares of Immunovant (IMVT) are on the rise in pre-market trading on September 9th, following the company’s announcement of positive data from a mid-stage study of its investigational candidate, batoclimab. Batoclimab is being developed as a potential treatment for Graves’ disease, an autoimmune disorder that affects the thyroid gland.
The Phase IIa study enrolled patients with uncontrolled Graves’ disease, meaning their hyperthyroid condition persisted despite treatment with anti-thyroid drugs. These patients were then treated with batoclimab in two phases: a 12-week period with a high dose (680 mg weekly subcutaneous injection) followed by another 12 weeks with a lower dose (340 mg weekly subcutaneous injection).
The results were promising. The high-dose batoclimab treatment led to a significant mean reduction of 77% in Immunoglobin G (IgG) levels after 12 weeks, with a 76% response rate in the patient population. This means that a large portion of the patients showed a positive response to the treatment. Furthermore, at the end of the first 12 weeks, 56% of the patients treated with the high-dose batoclimab achieved an ATD-Free Response, meaning they were able to discontinue their anti-thyroid drug therapy.
While the response rate decreased during the second 12 weeks of treatment with the lower dose, it’s important to note that the mean IgG level continued to decline. Notably, patients who achieved at least a 70% IgG reduction by the end of the study had a significantly higher ATD-Free Response rate (60%) compared to those who did not (23%).
Beyond the clinical data, Immunovant also highlighted the substantial unmet need for effective treatments for Graves’ disease. Real-world data suggests that a significant portion (25-30%) of patients with Graves’ disease remain uncontrolled on anti-thyroid drugs each year, with limited treatment options available. This creates a compelling market opportunity for Immunovant and its potential treatment.
Encouraged by the positive results from the Phase IIa study, Immunovant is gearing up to initiate a pivotal study of its lead candidate, IMVT-1402, for Graves’ disease by the end of 2024. IMVT-1402 is a novel and fully-human monoclonal antibody specifically designed to target the underlying cause of Graves’ disease. The company has already received clearance from the FDA for IMVT-1402 to treat Graves’ disease and has finalized the study design for the pivotal trial.
Immunovant’s ambitions extend beyond Graves’ disease. The company is conducting additional mid to late-stage studies evaluating batoclimab for the treatment of other autoimmune conditions, including Myasthenia gravis, chronic inflammatory demyelinating polyneuropathy, and thyroid eye disease. If these studies yield positive results, Immunovant plans to investigate IMVT-1402 as a potential treatment for these indications as well.
Over the next few years, Immunovant aims to initiate a significant number of clinical trials for IMVT-1402, potentially leading to several registrational programs. The company is leveraging the data from its batoclimab studies to optimize the development process for IMVT-1402 and achieve financial efficiencies.
The positive results from the mid-stage Graves’ disease study, combined with the company’s ambitious development plans, have sparked renewed investor interest in Immunovant. The company’s commitment to addressing the needs of patients with autoimmune diseases and its promising pipeline of investigational treatments make it a company to watch in the healthcare sector.
