• Afamelanotide monotherapy failed to achieve repigmentation in vitiligo patients
• Adjunct NB-UVB phototherapy required to activate pigment-producing cells
• No further monotherapy studies planned, focus on afamelanotide + NB-UVB

Clinuvel Pharmaceuticals has announced the final results from its Phase II pilot study CUV104, which evaluated SCENESSE (afamelanotide) as a monotherapy in patients with the depigmentation disorder vitiligo. The single-arm, open-label study failed to demonstrate repigmentation in the skin of the three adult vitiligo patients treated with afamelanotide alone for up to three months. While afamelanotide was well tolerated at a high dose, the lack of repigmentation illustrates the requirement for adjunct narrowband ultraviolet B (NB-UVB) phototherapy to effectively treat vitiligo patients with afamelanotide. NB-UVB is known to trigger the differentiation of stem cells adjacent to the hair follicle into fully functioning pigment-producing melanocytes. Earlier trials have shown that afamelanotide combined with NB-UVB can provide faster and more widespread repigmentation than NB-UVB alone. No further studies are planned to evaluate afamelanotide as monotherapy for vitiligo, with the ongoing CUV105 Phase III and planned CUV107 pivotal Phase III studies focusing on afamelanotide as a systemic repigmentation therapy with adjunct NB-UVB. The CUV104 results will be included in the regulatory dossier to be submitted for marketing authorization of afamelanotide in vitiligo, confirming Clinuvel's expertise that vitiligo cannot be effectively treated with a single modality.