Immunovant (IMVT) Study result summary

Brepocitinib program expansion and LPP study update

• Brepocitinib's development is expanding to include lichen planopilaris (LPP), a severe inflammatory scalp disorder with no approved therapies and significant unmet need.

• LPP affects up to 100,000 U.S. patients, causing irreversible hair loss, pain, and comorbidities, and is poorly controlled by current treatments.

• The mechanism of brepocitinib (JAK1/TYK2 inhibition) aligns with LPP's TH1-driven biology, supported by biomarker and clinical data from similar diseases and a small investigator-initiated trial.

• The new clinical program is a combined phase IIb/III trial, with a 72-patient phase IIb portion followed by a pivotal phase III, aiming for rapid progression to registration.

• The primary endpoint is IGA 0/1 responder rate, with aggressive washout of background meds and endpoints designed for regulatory alignment and clinical relevance.

Batoclimab phase III TED study results

• Phase 3 studies of batoclimab in thyroid eye disease (TED) did not meet the primary endpoint of ≥2mm proptosis responder rate at Week 24 after 12 weeks of high-dose and 12 weeks of low-dose treatment.

• Greater proptosis improvement was observed after the initial 12-week high-dose period compared to the subsequent low-dose period, indicating benefit from deeper IgG suppression.

• Hyperthyroid patients in the study showed an 80% responder rate for thyroid hormone normalization at week 12, consistent with prior phase II Graves' disease results.

• Safety profile remained consistent with previous findings, with no new safety signals identified.

• The TED study's outcome is not expected to negatively impact physician or payer perception of IMVT-1402 in Graves', as evidence suggests benefit in proptosis and early intervention.

Study design and patient population

• Phase 3 TED trial used a step-down dosing regimen: 680 mg batoclimab SC weekly for 12 weeks, then 340 mg SC weekly for 12 weeks, versus placebo for 24 weeks.

• Patients had active, moderate to severe TED, CAS ≥ 4, worsened proptosis, onset within 12 months, detectable TRAb, and controlled thyroid status.

• 200 patients were randomized 2:1 to batoclimab or placebo.