Teva Pharmaceutical Industries (TEVA) Study result summary

Disease background and unmet need

• Vitiligo is a chronic autoimmune disease causing loss of melanocytes and unpigmented skin patches, affecting 0.5%-2% of the global population and imposing significant psychosocial burden.

• Many cases are undiagnosed and most patients are undertreated, with only one FDA-approved topical therapy limited to small body surface areas.

Mechanism and candidate profile

• IL-15 is a key mediator in vitiligo pathogenesis, promoting melanocyte destruction via cytotoxic T cells.

• TEV-53408 (TEV-'408) is an anti-IL-15 monoclonal antibody designed for quarterly subcutaneous dosing, with high affinity, potency, and a prolonged half-life (38 days).

• Durable IL-15 blockade and rapid, sustained suppression of free IL-15 were observed, with effects lasting up to 80-90 days at the top dose.

Study design and endpoints

• Phase 1b open-label study enrolled 38 adults with active or stable non-segmental vitiligo, ~66% with >10% body surface area involvement.

• TEV-'408 was administered as two subcutaneous injections at baseline and week 12, with efficacy assessed at week 24 using F-VASI and T-VASI scores.

• Patients are monitored for up to 80 weeks for long-term outcomes.