Once-weekly batoclimab lowers immunoglobulin for adults with uncontrolled Graves’ disease
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Key takeaways:
- At 12 weeks, 76% of adults with Graves’ disease responded to once-weekly batoclimab.
- Immunovant plans to initiate a trial for investigational therapy IMVT-1402 by the end of the year.
Most adults who had uncontrolled Graves’ disease on antithyroid drugs responded to once-weekly subcutaneous batoclimab, according to top-line results released by Immunovant.
In a phase 2a trial, people with uncontrolled Graves’ disease who had hyperthyroidism despite antithyroid drug therapy received subcutaneous once-weekly 680 mg batoclimab (Immunovant) followed by 12 weeks of once-weekly 340 mg batoclimab. At 12 weeks, 76% of participants were deemed responders to batoclimab, with declines in triiodothyronine and thyroxine below the upper limit of normal without an increase in antithyroid drug dose, according to the release. Additionally, 56% of participants were responders and able to stop using antithyroid drugs entirely. The mean immunoglobulin decline was 77% at 12 weeks.
During the low-dose batoclimab phase from week 13 to week 24, 68% of participants were responders to the agent, with a mean immunoglobulin decline of 65%, while the percentage of participants who were responders and were able to taper completely off antithyroid drugs was 36%, according to the release.
The percentage of participants who were responders to batoclimab and were able to stop antithyroid drugs was higher among those who had an immunoglobulin decline of at least 70% by the end of the trial vs. those who did not (60% vs. 23%), the company stated in the release.
Pete Salzmann, MD, CEO of Immunovant, stated in the release that the findings revealed an opportunity for a novel therapy to treat Graves’ disease. The company plans to begin a pivotal trial for an investigational Graves’ disease therapy, IMVT-1402, by the end of 2024.
“We are thrilled to share these updates today which we believe validate a large and important degree of unmet medical need in patients uncontrolled on antithyroid drugs and which we believe demonstrate strong response rates in this same population,” Salzmann said in the release. “We find the correlation between clinical response and immunoglobulin lowering impressive and believe this creates not only a potential first-in-class, but also a potential best-in-class opportunity for IMVT-1402.”
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