Monday, Immunovant ( IMVT ), Inc. reported results from the Phase 2a trial of batoclimab in Graves’ Disease, an immune system condition that affects the thyroid gland. It causes the body to make too much thyroid hormone.

Immunovant ( IMVT ) is a member of the Roivant Sciences Ltd. ( ROIV )  family of companies.

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As previously disclosed, the batoclimab phase 2a trial in uncontrolled Graves’ Disease enrolled patients who were hyperthyroid despite antithyroid drugs (ATD) therapy.

Participants in the trial received 12 weeks of high-dose batoclimab, 680 mg weekly by subcutaneous injection (SC) followed by 12 weeks of lower-dose batoclimab, 340 mg weekly SC.

At the end of the first 12 weeks, participants experienced a mean IgG reduction of 77%, leading to a 76% Response rate.

In addition, by the end of 12 weeks of higher dose batoclimab, 56% achieved an ATD-Free Response.

Despite benefiting from a lower starting IgG level after 12 weeks of 680mg therapy, during Weeks 13 to 24, the lower 340mg dose of batoclimab resulted in a mean IgG reduction of 65% (vs. 77% on 680mg dose) with a corresponding lower responder rate of 68%.

In the second 12 weeks, a 36% lower ATD-Free Response rate was also observed.

Finally, patients who achieved at least a 70% IgG reduction at the end of the trial had nearly a threefold higher ATD-Free Response rate than those who did not (60% vs. 23%).

“We find the correlation between clinical response and IgG lowering impressive and believe this creates not only a potential first-in-class but also a potential best-in-class opportunity for IMVT-1402. We are very pleased to have aligned with the FDA on a pivotal trial design that we expect to initiate by the end of the year,” said Pete Salzmann, CEO of Immunovant ( IMVT ).

Immunovant ( IMVT ) also announced alignment with the FDA and Investigational New Drug Application clearance, with the initiation of a pivotal trial of IMVT-1402 in Graves’ Disease expected by December 31, 2024.

Price Action: ROIV stock is up 4.67% at $12.88, and IMVT stock is down 0.32% at $33.92 at last check Monday.

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