Teva Pharmaceutical Industries NYSE: TEVA said its internally developed anti-IL-15 antibody produced encouraging 24-week efficacy results in a phase 1b proof-of-concept study for vitiligo, as the company highlighted the program as part of its broader shift toward a biopharma-focused growth strategy.
During a conference call, President and CEO Richard Francis called the data “a milestone” in Teva’s “Pivot to Growth” plan and said 2026 is expected to include eight key events for the company, up from a prior expectation of seven following the addition of an ecopipam NDA filing.
Francis said Teva’s pipeline includes several programs that the company believes could each become $1 billion products in their respective indications, including anti-IL-15, duvakitug, emricasan, DARI, ecopipam and olanzapine-related programs. He said Teva expects its innovative portfolio to generate $3.5 billion of revenue in 2026.
Vitiligo Study Shows Facial and Total Body Responses
Eric A. Hughes, Teva’s EVP of Global R&D and Chief Medical Officer, said vitiligo is an autoimmune disease in which an immune reaction destroys melanocytes, leading to loss of pigmentation. He said the disease affects about 0.5% to 2% of the global population and carries a psychological burden, including anxiety, depression and social isolation.
Hughes said the only FDA-approved treatment currently available is a topical therapy for patients with less than 10% body surface area involvement, leaving a need for systemic options that can treat the whole body.
The phase 1b study evaluated Teva’s anti-IL-15 antibody in approximately 38 patients. Participants received one subcutaneous dose at day zero and another at week 12, with efficacy measured at 24 weeks. Hughes said 66% of patients in the study had skin involvement greater than 10% of their body surface area.
Teva reported the following 24-week results after two doses:
- 42% of patients achieved F-VASI50, representing at least a 50% improvement in facial vitiligo.
- 21% of patients achieved F-VASI75, representing at least a 75% improvement in facial vitiligo.
- 7% of patients achieved T-VASI50, representing at least a 50% improvement in total body vitiligo.
- 75% of patients reported improvement in facial skin using the facial Patient Global Impression of Change score, with half of those reporting “much” to “very much” improvement.
- 55% of patients reported improvement in total skin using the total Patient Global Impression of Change score.
Hughes said the patient-reported outcomes were particularly meaningful because patients monitor their skin daily and may be strongly affected by changes in appearance.
Company Highlights Quarterly Dosing Potential
Hughes said Teva believes its anti-IL-15 antibody is differentiated by its potency, long half-life and target engagement. He described the molecule as “Teva-born” and said it was created by the same internal team that developed duvakitug.
According to Hughes, the antibody has a half-life of about 38 days. He said the company observed rapid suppression of free IL-15 levels in serum within one or two days, and at the top dose, suppression below the limit of quantitation extended to about 80 to 90 days. Based on those data, Hughes said dosing once per quarter is a “strong possibility.”
Hughes said the drug has been “very well tolerated” to date, with no safety signals seen so far. In response to an analyst question, he said Teva has followed patients from earlier studies for extended periods, including out to about 400 days in some phase 1 work, and has not seen adverse events associated with IL-15 rebound as levels return to baseline.
Teva Compares Data With Oral JAK Programs
Hughes compared the phase 1b results with published data from upadacitinib, an oral JAK therapy that he said recently received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use.
He said Teva’s F-VASI50 result of 42% compared with 38% and 39% in the upadacitinib data he referenced. Teva’s F-VASI75 result of 21% compared with 19% and 14%, while its T-VASI50 result of 7% compared with 6% and 11%.
Hughes said Teva views the comparison as encouraging, particularly because its product is being developed as a subcutaneous injection given once every quarter. He contrasted that with daily oral JAK therapy, which he said carries a black box warning.
Phase 2 Plans and Additional Indications
Teva said it has already met with the FDA and is incorporating the agency’s feedback into a phase 2 study expected to begin this year. Hughes said the company plans dose-ranging work in phase 2b and is discussing a seamless study design that could allow the program to move efficiently toward phase 3.
Hughes said Teva expects facial VASI and total VASI endpoints to be used in later-stage development, with baseline criteria likely to include greater than 0.5 on facial VASI and greater than five on total VASI. He also said Teva will continue monitoring phase 1b subjects out to 80 weeks.
Teva also emphasized potential applications for anti-IL-15 beyond vitiligo. Hughes said IL-15 may be relevant in alopecia areata, celiac disease, eosinophilic esophagitis and atopic dermatitis. The company expects proof-of-concept data from a phase 2a celiac disease study in the second half of the year.
That celiac study, Hughes said, includes about 50 patients in a placebo-controlled gluten challenge design. Patients receive either active treatment or placebo, then undergo a gluten diet challenge, with biopsies used to evaluate effects on gut histology. Hughes said the crypt depth-to-villus height ratio will be the most important readout.
Francis closed the call by saying the anti-IL-15 vitiligo data represent the second of eight expected milestones for Teva this year, with additional pipeline updates anticipated in the coming months.
About Teva Pharmaceutical Industries NYSE: TEVA
Teva Pharmaceutical Industries Ltd. NYSE: TEVA is an Israeli multinational pharmaceutical company and one of the world's largest manufacturers of generic medicines. The company's core activities include the development, production and marketing of generic pharmaceuticals alongside a portfolio of specialty branded medicines. Teva supplies finished dosage forms and active pharmaceutical ingredients (APIs) to markets around the globe and operates manufacturing and research facilities in multiple countries.
Teva's product range covers oral solids, injectables, inhalation products and other dosage forms across therapeutic areas such as central nervous system disorders, respiratory, oncology, pain and infectious disease.
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