Teva to Advance Its Anti-IL-15 Antibody, Designed for Quarterly Dosing, Into Phase 2b Development in Vitiligo, Following Encouraging Phase 1b Results
- Teva-discovered TEV-408 targets IL-15, a key driver of vitiligo biology
- TEV-408 showed improvement in skin pigmentation and was well-tolerated with no safety signals observed to date
- Nearly 75% of patients reported improvement in facial vitiligo, with half reporting much or very much improved
- TEV-408 is designed for convenient quarterly (Q12W) subcutaneous dosing
Teva will hold an investor call and live webcast today,
Tuesday, July 7, 2026, at 8:00 a.m. ET to discuss these data.
TEL AVIV, Israel, July 07, 2026 (GLOBE NEWSWIRE) -- Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced plans to advance its TEV-408, an investigational anti-interleukin-15 monoclonal antibody, into a Phase 2b study in vitiligo in the fourth quarter of 2026. The decision follows encouraging results from an ongoing Phase 1b, open-label study in adults with active or stable non-segmental vitiligo (NSV).
Data from the ongoing, open-label Phase 1b study showed improvements in skin pigmentation in patients with active or stable NSV. TEV-408 was well-tolerated with no safety signals observed to date. 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, with half reporting much or very much improved
- 42% achieved F-VASI50 and 21% achieved F-VASI75
- 55% of patients reported improvement in total body vitiligo
- 7% achieved T-VASI50
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.
Vitiligo is a chronic autoimmune disease that causes loss of skin pigmentation and can have a significant impact on quality of life, self-image, and daily social interactions. Despite recent advances, treatment options remain limited, particularly for patients with more extensive disease, who may require systemic therapy, or those seeking better disease control.
Vitiligo 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 pathway and reflect the depth of Tevas scientific expertise. We are excited by the potential of this program to offer a meaningful new option for people living with vitiligo.
Teva Investor Call
Teva will hold an investor call and live webcast today, Tuesday, January 7, 2026, at 8:00 a.m. ET/ 2:00 p.m. CET to discuss these data. To participate, please register in advance here. To access a live webcast of the presentation, visit Tevas Investor Relations website at https://ir.tevapharm.com/Events-and-Presentations. An archived version of the webcast will be available 24 hours after the end of the live discussion.
TEV-408 Phase 1b Study Design
The ongoing open-label phase 1b study enrolled adults with active or stable NSV with an F-VASI > 0.5 or a T-VASI > 5. Anti-IL-15 was administered as two subcutaneous injections on Day 0 and at week 12. The primary measure of efficacy is the Vitiligo Area Severity Index (VASI) at week 24. Monitoring of patients extends through week 80.
About TEV-408
TEV-408, discovered by Teva, is an investigational human monoclonal antibody designed to inhibit interleukin-15 (IL-15), a cytokine involved in immune-mediated pathways. TEV-408 has a high affinity and potency (in vitro) as well as a prolonged half-life, with a planned convenient quarterly (Q12W), subcutaneous dosing.
In addition to being studied as a potential therapy for vitiligo, TEV-408 is being evaluated for celiac disease in a Phase 2a study and was granted Fast Track designation in that indication by the U.S. FDA in May 2025.
By blocking IL-15 activity, TEV-408 aims to reduce the immune-mediated destruction of melanocytes (pigment producing cells) resulting in white patches on the skin characteristic of vitiligo or reduce the IL-15-driven intestinal inflammation and damage characteristic of celiac disease.
As previously announced, Tevas agreement with Royalty Pharma provides Teva with 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.
About Vitiligo
Vitiligo is a chronic autoimmune skin disease characterized by the loss of pigment-producing cells (melanocytes), resulting in white patches that can appear anywhere on the body. Affecting people of all ages, skin types, and ethnicities, vitiligo has an estimated global prevalence of 0.5% to 2%, although many individuals remain undiagnosed.
Beyond its physical manifestations, vitiligo can impose a significant emotional and psychosocial burden, with many people experiencing anxiety, depression, and social isolation. Current treatment options are limited, particularly for people with more extensive disease. Only one topical therapy is approved, and its use is restricted to treating up to 10% of the body surface area. As a result, many people with vitiligo remain insufficiently treated, underscoring the need for systemic therapies that can support meaningful and durable repigmentation.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is transforming into a leading innovative biopharmaceutical company, enabled by a world-class generics business. For over 120 years, Tevas commitment to bettering health has never wavered. From innovating in the fields of neuroscience and immunology to providing complex generic medicines, biosimilars and pharmacy brands worldwide, Teva is dedicated to addressing patients needs, now and in the future. At Teva, We Are All In For Better Health.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on managements current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as should, expect, anticipate, estimate, target, may, intend, plan, believe and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully develop and commercialize TEV-408 for the treatment of vitiligo; our ability to successfully compete in the marketplace, including our ability to develop and commercialize additional pharmaceutical products; our ability to successfully execute on our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development; and other factors discussed in our Quarterly Report on Form 10-Q for the first quarter of 2026 and in our Annual Report on Form 10-K for the year ended December 31, 2025, including in the sections captioned Risk Factors and Forward-Looking Statements. Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.
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