Immunovant (IMVT) Status Update summary

Clinical trial results and efficacy

• High-dose batoclimab (680 mg) achieved a 76% response rate and 56% ATD-free response at 12 weeks in Graves' patients uncontrolled on ATDs, with a 77% mean IgG reduction; lower dose (340 mg) at 24 weeks showed a 68% response and 36% ATD-free rate, with a 65% mean IgG reduction.

• Deeper IgG reduction (>70%) correlated with higher ATD-free response, with patients achieving this threshold having nearly triple the ATD-free response rate.

• T3 and T4 normalized rapidly by week 6, with improvements sustained through week 12; most patients began tapering ATDs early.

• Safety profile was favorable, with only mild or moderate adverse events and no treatment-related serious events or new safety signals.

• Durability of response tracks with IgG suppression; longer, potent therapy may convert more patients to responders.

Pivotal trial design and regulatory status

• IND for IMVT-1402 in Graves' disease is cleared, with the first pivotal trial set to start by year-end 2024, randomizing 240 adults with active Graves' disease uncontrolled on ATDs to IMVT-1402 or placebo for 52 weeks.

• The primary endpoint at 26 weeks is the proportion of patients who become euthyroid and stop ATD therapy; a key secondary endpoint at 52 weeks assesses sustained response.

• Two pivotal trials will run in parallel, with the second likely to include patients with thyroid eye disease.

• Remission rates (off ATD and off drug) will be evaluated, with top-line results expected at 52 weeks.

• FDA alignment achieved on pivotal trial design, with forward-looking statements noting risks related to clinical development, regulatory approval, and commercialization.

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, adverse events, and lifelong hormone replacement.

• Multiple analyses confirm 25%-30% of Graves' patients are uncontrolled, relapsed, or intolerant to ATDs, representing a significant unmet need.

• Shift away from ablation has increased the pool of patients needing alternatives to ATDs.

• Many patients seek therapies that address underlying disease pathology.