Clinuvel Pharmaceuticals (ASX: CUV) has announced the successful recruitment of over 200 patients for its Phase III (CUV105) clinical trial evaluating Scenesse (afamelanotide 16mg) as a repigmentation therapy for vitiligo. The randomized, 20-week trial is being conducted across 37 sites in North America, Africa, and Europe, with a significant 57% of patients enrolled in the United States. The last patient screening is scheduled for completion this month, and the company anticipates the release of initial results in late 2026.
According to Clinuvel, the trial will evaluate Scenesse as a systemic repigmentation therapy, particularly focusing on adolescents and adults with darker skin types. Patients will receive Scenesse in conjunction with narrowband ultraviolet B (NB-UVB) phototherapy or NB-UVB monotherapy. The trial’s primary endpoint will be assessed using the Vitiligo Area Scoring Index (VASI), targeting a minimum of 50% repigmentation across the total body surface area. Secondary endpoints include evaluating repigmentation on the face, neck, and head at week 20, and monitoring the maintenance of repigmentation post-treatment. All patients will undergo a six-month follow-up period after completing the study.
Clinuvel’s director of global clinical affairs, Dr. Emilie Rodenburger, highlighted the company’s enthusiasm for reaching the enrollment milestone. She emphasized the establishment of a North American distribution network among dermatologists, positioning the company for market entry of its innovative product. The company is also preparing for its second large Scenesse trial, CUV107, with ongoing regulatory discussions in Europe, Africa, and North America. Vitiligo, an acquired depigmentation disorder affecting approximately 2% of the global population, results in the progressive loss of melanin-producing skin cells. It disproportionately affects individuals with darker skin types, including an estimated 820,000 people in North America.
