Teva is planning to progress its anti-IL-15 therapy, TEV-‘408 into a Phase IIb trial in vitiligo after the drug demonstrated promise in an ongoing Phase Ib open-label study.
The Phase Ib trial enrolled adults with either active or stable non-segmental vitiligo (NSV). Patients were randomised to receive either placebo or two doses of the subcutaneous study drug on day zero and week 12 – with monitoring extending through to week 80.
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During the trial, TEV-‘408 triggered improvements in skin pigmentation in both active and stable NSV, as 42% and 21% of patients experienced 50% and 75% improvements in facial pigmentation, respectively. When looking at the presence of vitiligo on the entire body, 7% of patients achieved a 50% reduction.
Additionally, nearly 75% of the patients enrolled on the trial reported subjective improvements in their facial vitiligo, with half of this population noting this symptom to be ‘much’ or ‘very much’ improved following treatment.
Alongside its early signs of efficacy, Teva says that TEV-‘408 also proved well tolerated in this population, with no safety signals linked to the drug observed to date.
Following the positive outcome of this study, Teva expects to initiate a Phase IIb study of the quarterly-dosed drug in the final quarter of 2026.
Teva pushes TEV-‘408 along the pipeline as several big pharma players race to break onto the vitiligo market. Currently, US regulators have approved only one topical therapy, Incyte and Novartis’ Opzelura/Jakavi (ruxolitinib), which patients can use on only ≤10% of the body.
One of the prime contenders is AbbVie, which is awaiting NSV approval decisions from both US and European regulators on its blockbuster Janus kinase (JAK) inhibitor, Rinvoq (upadacitinib), which has already embedded its roots in nine different indications across rheumatological, dermatological and gastrointestinal disorders.
Pfizer is also eyeing a label expansion for its alopecia pill and kinase inhibitor, Litfulo (ritlecitinib), which the company is currently evaluating for vitiligo in the Phase III Tranquillo programme.
TEV-‘408’s ‘pipeline in a product’ potential
In an investor call discussing the Phase Ib NSV results, Teva’s head of R&D and CMO, Eric Hughes, noted that TEV-‘408 could constitute a “pipeline in a product” opportunity for the company.
Teva is currently exploring this claim through a Phase IIa trial enrolling patients with celiac disease. The pharma company expects it to read out in the second half of 2026.
Alongside its potential in NSV and celiac, Hughes touted the drug’s possible role in treating eosinophilic oesophagitis, as well as alopecia areata and atopic dermatitis.
Teva is not the only company exploring the wide-spanning potential of targeting IL-15, however, as there are currently 29 drugs in clinical development that harness this target – of which just over one-fifth are IL-15 inhibitors, according to GlobalData’s Pharmaceutical Intelligence Center.
GlobalData is the parent company of Clinical Trials Arena.
