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Immunovant Inc (NASDAQ:IMVT), on Thursday, released the results from the initial cohort of patients in an ongoing 24-week Phase 2 trial of batoclimab in patients with Graves' disease.
Graves' disease is an immune system disorder that results in the overproduction of thyroid hormones (hyperthyroidism).
The company says the results show that batoclimab meaningfully exceeded 50% response rates.
Consistent with studies of batoclimab in other indications, 680 mg administered subcutaneously (SC) in the initial cohort demonstrated an IgG reduction of up to 87%, with a mean IgG reduction of 81% after 12 weeks of treatment.
The 340 mg IgG reductions were lower. A similar dose response was observed for anti-TSHR autoantibodies, with deeper reductions observed following treatment with 680 mg of SC batoclimab compared to 340 mg of SC batoclimab.
In addition, numerically higher responses were observed following treatment with 680 mg of batoclimab across a range of clinical parameters compared to treatment with 340 mg of batoclimab.
Batoclimab was generally well tolerated, with no new safety signals observed in the initial data set.
"While this trial is ongoing, we intend to focus our future development in Graves' on IMVT-1402, with plans expected to be announced later in 2024," said Pete Salzmann, chief executive officer at Immunovant, a unit of Roivant Sciences Ltd (NASDAQ:ROIV).
In September, Immunovant announced that subcutaneously administered doses of IMVT-1402 produced dose-dependent reductions in Immunoglobulin G (IgG) in initial data from a Phase 1 trial in healthy adults, with no dose-related changes in serum albumin or LDL-C.
Price Action: IMVT shares are up 12.10% at $40.56 during the premarket session on the last check Thursday.
