Immunovant, Inc. (NASDAQ: IMVT) has reported positive results from the phase 2a trial of batoclimab in Graves’ disease. The trial involved patients who were hyperthyroid despite antithyroid drug (ATD) therapy. High dose batoclimab, administered at 680 mg weekly by subcutaneous injection, led to a 77% reduction in mean IgG levels and a 76% response rate at week 12, defined as T3 and T4 falling below the upper limit of normal without increasing the ATD dose. Additionally, 56% of the patients achieved an ATD-free response at the end of the 12 weeks.
Following the initial 12 weeks of high dose batoclimab, a lower dose of 340 mg weekly resulted in a mean IgG reduction of 65% and a responder rate of 68% during weeks 13 to 24. The lower dose also led to a lower ATD-free response rate of 36%. Notably, patients who achieved at least a 70% IgG reduction at the end of the trial had a significantly higher ATD-free response rate compared to those who did not, at 60% versus 23%.
The company highlighted that a strong correlation was observed between the degree of IgG lowering and clinical outcomes, indicating a potential first-in-class and best-in-class opportunity for IMVT-1402 in Graves’ disease. Immunovant also disclosed data from proprietary market research studies that showed a consistent unmet need among ATD-treated patients who are intolerant to, uncontrolled on, or relapsed after ATDs.
The company also announced alignment with the U.S. Food & Drug Administration (FDA) and investigational new drug application (IND) clearance with initiation of a pivotal trial of IMVT-1402 in Graves’ disease expected by December 31, 2024.
Pete Salzmann, M.D., Chief Executive Officer of Immunovant, expressed enthusiasm regarding the updates, stating that they validate a significant unmet medical need in patients uncontrolled on ATDs, and demonstrate strong response rates in this population. He also noted the impressive correlation between clinical response and IgG lowering, creating potential opportunities for IMVT-1402.
Immunovant will host a webcast at 8:00 a.m. ET today to discuss these updates. A replay of the event and presentation will be available immediately following the event. As a result of these announcements, the company's shares have moved 1.2% on the market, and are now trading at a price of $34.03. If you want to know more, read the company's complete 8-K report here.
