Vitiligo - CUV105 Study Update

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Stock Clinuvel Pharmaceuticals Ltd (CUV.ASX)
Release Time 20 Jan 2025, 9:39 a.m.
Price Sensitive Yes
 Vitiligo - CUV105 Study Update
Key Points
  • Total body darkening of unaffected skin demonstrates systemic effect, followed by visible repigmentation of vitiligo lesions
  • Patients counselled to anticipate total body darkening, broadly accepted in skin type III-VI
  • In two cases, spontaneous repigmentation months after treatment - previously unreported
Full Summary

Clinuvel Pharmaceuticals has shared new clinical observations from the CUV105 study evaluating afamelanotide as an adjunct to narrowband UVB (NB-UVB) therapy for non-segmental vitiligo patients with Fitzpatrick Skin Types III-VI. The study aims to assess the ability of afamelanotide to induce follicular and peripheral melanogenesis to repigment vitiligo lesions. Four case reports are discussed, demonstrating a consistent pattern of response over 7 stages: 1) initial follicular redness/pinkness at 2-3 weeks, 2) persistent follicular response at 3-4 weeks, 3) darkening of unaffected skin at 4-5 weeks, 4) browning of follicular islands at 5-8 weeks, 5) fusion of follicular islands and epidermal repigmentation at 9-16 weeks, 6) overall darkening and reduction in contrast between affected and unaffected skin at 17-26 weeks, and 7) continued repigmentation to reduce vitiligo lesions by over 50% after 26 weeks. Importantly, two cases showed spontaneous continued repigmentation months after completing treatment, a previously unreported observation. Physicians and patients have provided positive feedback on the clinical benefit observed thus far, with patients who initially received NB-UVB alone electing to continue in the trial and receive the afamelanotide adjunct therapy.