CLINUVEL Pharmaceuticals (ASX:CUV) has presented new evidence of its lead therapy SCENESSE (afamelanotide) delivering visible and lasting repigmentation in patients with vitiligo, one of the world’s most common pigmentary disorders.
The findings were shared last week at the European Academy of Dermatology and Venereology (EADV) congress in Paris.
The results came from three patients enrolled in the company’s ongoing CUV105 study at a reference hospital in La Réunion, France. Each received seven SCENESSE implants in combination with up to 40 narrowband ultraviolet B (NB-UVB) phototherapy sessions. At a follow-up visit 14 weeks after treatment completion, physicians observed stable and in some cases spontaneous repigmentation, confirming earlier signals from the trial.
All three patients had Fitzpatrick skin types four and five and long-standing vitiligo, including cases resistant to other therapies. According to CLINUVEL, no unexpected safety issues were identified, and patients reported satisfaction with their outcomes.
Dr Emilie Rodenburger, CLINUVEL’s Director of Global Clinical Affairs, said the case studies underscored the treatment’s potential. “Vitiligo patients receiving SCENESSE understand that temporary darkening of the entire skin surface is required to activate the pigment to reverse vitiligo. Most satisfying is to hear how patients are receiving benefit from treatment and the shared excitement from the treating physicians who may have, for the first time, a therapy that works for patients with extensive vitiligo. We look forward to learning the full study results in 2026.”
Clinical photographs presented at EADV showed progressive repigmentation of facial and body regions, with skin tone returning towards baseline over time. One patient, who had previously relapsed following partial treatment response, demonstrated near-complete restoration of colour around the eyes by day 224 of the study.
Vitiligo affects millions worldwide, often with profound psychosocial consequences due to visible loss of skin colour. Existing treatments, including topical agents and phototherapy, have limited effectiveness in patients with widespread or resistant disease.