Immunovant, Inc. (NASDAQ: IMVT) has released positive results from the phase 2a trial of batoclimab in Graves’ disease. The trial involved patients who were hyperthyroid despite antithyroid drug (ATD) therapy. The high dose of batoclimab, administered weekly by subcutaneous injection, led to a 76% response rate in patients uncontrolled on ATDs at week 12. Additionally, a 56% ATD-free response rate was achieved in these patients at week 12.
Furthermore, there was a strong correlation observed between the degree of IgG lowering and clinical outcomes, indicating a potential best-in-class and first-in-class opportunity for IMVT-1402 in Graves’ disease.
Real-world claims data showed that 25-30% of Graves’ disease patients per year are uncontrolled on ATDs with minimal to no existing therapeutic options, presenting an attractive commercial opportunity with limited competition.
Immunovant has also received Investigational New Drug Application (IND) clearance with initiation of the pivotal trial of IMVT-1402 in Graves’ disease expected by the end of the calendar year.
Pete Salzmann, M.D., Chief Executive Officer of Immunovant, expressed enthusiasm about the updates, emphasizing the validation of a significant unmet medical need in patients uncontrolled on ATDs and the strong response rates in this population. He highlighted the impressive correlation between clinical response and IgG lowering and the potential for IMVT-1402 to be a first-in-class and best-in-class opportunity.
The company will be hosting a webcast to discuss these updates at 8:00 a.m. ET today.
Immunovant, Inc. is focused on developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases. As a result of these announcements, the company's shares have moved 1.7% on the market, and are now trading at a price of $12.52. Check out the company's full 8-K submission here.
