Teva to Advance Anti-IL-15 Antibody TEV-408 Into Phase 2b for Vitiligo Following Promising Phase 1b Results
核心洞察
Teva announced plans to advance its investigational anti-IL-15 (搜索) monoclonal antibody TEV-408 into a Phase 2b study in vitiligo (搜索) in Q4 2026, following encouraging Phase 1b data.
At week 24, nearly 75% of patients reported improvement in facial vitiligo (搜索), with 42% achieving F-VASI50 and 21% achieving F-VASI75, while no safety signals were observed.
TEV-408 is designed for convenient quarterly (Q12W) subcutaneous dosing and targets IL-15 (搜索), a key driver of immune-mediated melanocyte destruction in vitiligo (搜索).
Teva Pharmaceutical Industries (搜索) Ltd. announced on July 7, 2026, that it will advance its investigational anti-interleukin-15 (IL-15 (搜索)) monoclonal antibody, TEV-408, into a Phase 2b clinical study in vitiligo (搜索) in the fourth quarter of 2026. The decision follows encouraging data from an ongoing Phase 1b, open-label study evaluating the therapy in adults with active or stable non-segmental vitiligo (NSV).
"TEV-408 exemplifies the type of innovative, Teva-discovered program we are prioritizing as we continue to advance and strengthen our immunology pipeline," said Richard Francis, President and Chief Executive Officer of Teva. "Grounded in compelling biology and focused on meaningful unmet need, TEV-408 reflects our progress in our Pivot to Growth strategy and our commitment to pursuing differentiated innovation for patients."
Phase 1b Efficacy Results
The ongoing open-label Phase 1b study enrolled adults with active or stable NSV with a Facial Vitiligo (搜索) Area Severity Index (F-VASI) greater than 0.5 or a Total Vitiligo Area Severity Index (T-VASI) greater than 5. At baseline, 66% of enrolled participants had vitiligo affecting more than 10% of body surface area, representing a population with limited treatment options.
At week 24, in evaluable participants, nearly 75% of patients reported improvement in facial vitiligo (搜索), with half reporting "much" or "very much" improved. On objective measures, 42% of patients achieved F-VASI50 and 21% achieved F-VASI75. Additionally, 55% of patients reported improvement in total body vitiligo, while 7% achieved T-VASI50.
TEV-408 was well-tolerated with no safety signals observed to date.
Mechanism and Dosing
TEV-408, discovered by Teva, is a human monoclonal antibody designed to inhibit IL-15 (搜索), a cytokine involved in immune-mediated pathways. By blocking IL-15 activity, TEV-408 aims to reduce the immune-mediated destruction of melanocytes — the pigment-producing cells whose loss results in the characteristic white patches of vitiligo (搜索). The antibody has demonstrated high affinity and potency in vitro as well as a prolonged half-life, enabling a planned convenient quarterly (Q12W) subcutaneous dosing regimen.
In the Phase 1b study, TEV-408 was administered as two subcutaneous injections on Day 0 and at week 12, with the primary efficacy measure being VASI at week 24. Patient monitoring extends through week 80.
Unmet Need in Vitiligo (搜索)
Vitiligo (搜索) is a chronic autoimmune skin disease with an estimated global prevalence of 0.5% to 2%, though many individuals remain undiagnosed. Beyond its physical manifestations, the disease can impose a significant emotional and psychosocial burden, with many patients experiencing anxiety, depression, and social isolation.
"Vitiligo (搜索) can affect far more than the skin. It can shape how people see themselves, how they show up in the world, and the confidence they carry every day," said Eric Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer at Teva. "These encouraging data strengthen our confidence in the IL-15 (搜索) pathway and reflect the depth of Teva's scientific expertise. We are excited by the potential of this program to offer a meaningful new option for people living with vitiligo."
Current treatment options remain limited, particularly for patients with more extensive disease. Only one topical therapy is approved, and its use is restricted to treating up to 10% of body surface area, underscoring the need for systemic therapies that can support meaningful and durable repigmentation.
Strategic Funding and Additional Indications
Teva's agreement with Royalty Pharma (搜索) provides up to $500 million of strategic R&D funding to further accelerate the clinical research program of TEV-408, including the planned Phase 2b study in vitiligo (搜索). Beyond vitiligo, TEV-408 is also being evaluated for celiac disease (搜索) in a Phase 2a study and was granted Fast Track designation in that indication by the U.S. FDA in May 2025.