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About Clinuvel (ASX:CUV)
Clinuvel Pharmaceuticals Limited is an ASX-listed biopharmaceutical company based in Melbourne. It develops photoprotective and repigmentation therapies, and its lead product SCENESSE (afamelanotide) is approved for adult patients with erythropoietic protoporphyria, a disorder involving intolerance to light.
Clinuvel Pharmaceuticals Limited (ASX:CUV) provided an update on the clinical and regulatory path for its drug SCENESSE (afamelanotide) used with adjuvant narrowband ultraviolet B (NB-UVB) phototherapy to treat vitiligo patients with darker skin colour. The Company's first late-stage study, CUV105, which has enrolled 210 patients globally, is evaluating SCENESSE with adjunct NB-UVB against NB-UVB monotherapy over a 20-week treatment period in patients with Fitzpatrick III-VI skin types, using the validated Vitiligo Area Scoring Index and photographic evidence. Topline results are anticipated for release in December 2026, with the primary endpoint being the proportion of patients achieving a total body surface area response of at least 50% (T-VASI50) and the secondary endpoint facial repigmentation of at least 75% (F-VASI75).
The CUV105 study will be followed by the pivotal registration study CUV107. The European Medicines Agency reviewed the CUV107 protocol in April 2026 and advised on its design; it was agreed that the study would include 300 vitiligo patients with darker skin types (Fitzpatrick IV-VI). CUV107 is anticipated to start in November 2026, with a 12-month recruitment period planned. SCENESSE is not currently approved for vitiligo anywhere in the world, but the drug is marketed for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria.
Source: Clinuvel Pharmaceuticals Limited (ASX:CUV), 28 July 2026. Summary content supplied by Digifin Pty Ltd.
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