Immunovant (IMVT) Study result summary

Brepocitinib program expansion and LPP study update

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

• The LPP program is structured as a combined phase IIb/III trial, with a 72-patient phase IIb portion followed by a pivotal phase III enrolling approximately 270 patients, aiming for a straight-to-registrational approach.

• LPP is characterized by irreversible hair loss, scarring, pain, and comorbidities, and current treatments are largely ineffective, leading to polypharmacy and poor disease control.

• Brepocitinib's mechanism, targeting JAK1/TYK2, aligns with the TH1-driven biology of LPP, supported by biomarker and clinical data from prior studies and investigator-initiated trials.

• The primary endpoint for the pivotal study is expected to be IGA 0/1 responder rate, with aggressive washout of background meds and endpoints designed for regulatory alignment.

Batoclimab phase III TED study results

• Phase 3 studies of batoclimab in thyroid eye disease 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 better proptosis response and thyroid normalization rates, consistent with prior phase II Graves' disease results.

• Pooled analysis showed mean proptosis reduction at week 12 was nominally significant: -0.84 mm for batoclimab vs -0.31 mm for placebo (p=0.0152).

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

Study design and patient population

• Phase 3 trial in thyroid eye disease (TED) 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.

• Primary endpoint: proptosis responder rate at week 24, defined as ≥2 mm reduction in study eye without ≥2 mm increase in fellow eye.

• Key secondary endpoints included proportion with proptosis ≥2 mm reduction and CAS ≤3, and proportion with CAS 0 or 1 at week 24.