Clinuvel Sets Vitiligo Benchmarks Before CUV105 Data

Clinuvel Pharmaceuticals Limited (ASX:CUV) released a commercial update on the emerging vitiligo market, setting out peer reviewed benchmarks for the current standard of care, narrowband ultraviolet B (NB-UVB) phototherapy, and for Janus kinase (JAK) inhibitors under development. The company said extensive vitiligo, defined as at least 10% of total body surface affected by depigmentation, lacks an effective therapy, with NB-UVB remaining the preferred first-line whole-body phototherapy. Cited NB-UVB data include a 2025 study of 176 patients in which 45% achieved clinically significant repigmentation, and an analysis of 1,428 patients across 35 studies showing a marked response in 19% after six months and 36% after 12 months. For topical ruxolitinib, Phase II results (n=157) showed F-VASI50 at week 24 of 45% and 50% across dosing arms versus 3% for vehicle, while Phase III results (n=674) showed F-VASI75 at week 52 in 50.3% of patients treated throughout. Among oral JAK inhibitors, upadacitinib Phase III studies (n=614) reported T-VASI50 of 19.4% and 21.5% versus 5.9% for placebo, and povorcitinib top-line Phase III results (n=917) showed 18.9% achieving F-VASI75 after 52 weeks. Clinuvel noted that ruxolitinib and other JAK inhibitors carry a boxed warning covering serious infections, malignancy, major adverse cardiovascular events, mortality and thrombosis.

Clinuvel said SCENESSE (afamelanotide) is being developed as the first systemic total body repigmentation therapy for vitiligo, targeting melanocortin receptors to stimulate melanin synthesis alongside adjunct NB-UVB, in contrast to the immune suppression mechanism of JAK inhibitors. Early clinical data from the CUV105 study include 12 case reports in which physicians observed progressive repigmentation of facial and body regions following SCENESSE implant injections and up to 40 adjunct NB-UVB sessions. Prior CUV102 and CUV103 studies showed the combination significantly improves repigmentation compared with NB-UVB monotherapy, while a pilot study confirmed SCENESSE as monotherapy is unable to provoke repigmentation. Topline results of CUV105 are anticipated in December 2026 and the pivotal CUV107 study is anticipated to start in November 2026. The company said it has reinforced its supply chain, scaled up North American infrastructure and engaged more than 100 potential new Specialty Centers at the American Academy of Dermatology meeting in 2026. Chief Scientific Officer Dr Dennis Wright said the benchmarks provide a reference for evaluating afamelanotide and adjunct NB-UVB in future.