Immunovant (IMVT) Status Update summary

Clinical Data and Proof of Concept

• High-dose batoclimab (680 mg weekly) achieved a 76% response rate and 56% ATD-free rate at 12 weeks in uncontrolled Graves' patients, exceeding predefined success bars for both endpoints.

• Strong correlation observed between depth of IgG reduction and clinical response; >70% IgG reduction linked to nearly triple the ATD-free response rate.

• Lower dose (340 mg) led to a reduced response (68%) and ATD-free rate (36%) at 24 weeks, likely due to less IgG suppression.

• Safety profile was favorable, with most adverse events mild or moderate and unrelated to treatment.

• Normalization of T3 and T4 was rapid and sustained, with minimal fluctuations and effective ATD tapering.

Graves' Disease Overview and Unmet Need

• Graves' disease is an autoimmune disorder caused by autoantibodies to the TSH receptor, leading to excess thyroid hormone production and significant morbidity.

• Standard treatments (ATDs, radioactive iodine, surgery) have seen little innovation in 70+ years and are associated with high relapse rates and adverse events.

• 25-30% of patients are relapsed, uncontrolled, or intolerant to ATDs, with many seeking therapies that address underlying disease pathology.

Pivotal Trial Design and Regulatory Status

• IND for IMVT-1402 in Graves' disease has cleared, with pivotal trial initiation expected by year-end 2024.

• The pivotal trial will randomize adults with active Graves' disease uncontrolled on ATDs to IMVT-1402 or placebo, with primary endpoint at 26 or 52 weeks: proportion euthyroid and off ATD.

• Secondary endpoint at 52 weeks includes remission rates after 6 or 12 months of therapy.

• FDA alignment achieved on pivotal trial design for IMVT-1402.

• Second pivotal trial may include patients with overlapping thyroid eye disease.