Clinuvel Pharmaceuticals has successfully recruited over 200 patients for its Phase III clinical trial evaluating SCENESSE® (afamelanotide 16mg) as a systemic repigmentation therapy for vitiligo, marking a significant milestone in the company's development program.
The randomized 20-week trial, designated CUV105, is being conducted across 37 clinical sites spanning North America, Africa, and Europe, with 57% of enrolled patients located in the United States. The final patient is expected to complete screening this month, with first results anticipated in the second half of 2026.
Trial Design and Treatment Protocol
In the CUV105 study, patients are receiving treatment every three weeks with either SCENESSE® alongside adjuvant narrowband ultraviolet B (NB-UVB) phototherapy administered twice weekly for five months, or NB-UVB monotherapy alone twice weekly for the same duration. Patients assigned to the NB-UVB monotherapy arm will be eligible to receive SCENESSE® with adjuvant NB-UVB after completing their follow-up period.
The primary endpoint of the trial utilizes the Vitiligo Area Scoring Index (VASI) to evaluate achievement of at least 50% repigmentation across the total body surface area. Secondary endpoints include assessments of repigmentation specifically on the face, neck, and head at week 20, as well as maintenance of repigmentation following treatment completion. All participants will receive follow-up for six months after the study concludes.
Dr. Emilie Rodenburger, Director of Global Clinical Affairs at Clinuvel, expressed enthusiasm about the enrollment milestone: "We are thrilled with the enrollment milestone. We are essentially establishing a North American distribution network among dermatologists, anticipating the necessary infrastructure ahead of market entry for our breakthrough product."
Promising Early Clinical Observations
The company has previously released case studies demonstrating the potential efficacy of SCENESSE®. Four case studies involving patients with skin type IV and varying disease duration showed repigmentation of vitiliginous lesions on the face or back after just four weeks of treatment initiation. Some patients experienced additional spontaneous repigmentation after concluding the treatment protocol.
A fifth case study demonstrated repigmentation of lesions on the arms and legs in a skin type V patient with a 20-year history of vitiligo. All patients reported satisfaction with treatment results and tolerated the combination of afamelanotide with adjunct NB-UVB therapy.
"The first clinical observations of our systemic solution have been encouraging," Dr. Rodenburger noted, "and we will continue regulatory discussions in Europe, Africa and North America in anticipation of CUV107, which will be our second large SCENESSE® trial."
Addressing an Unmet Medical Need
Vitiligo is an acquired depigmentation disorder affecting approximately 2% of the global population, characterized by progressive loss of functional melanin-producing skin cells. While the condition impacts all sufferers, it has particularly severe effects on individuals with darker skin types, including an estimated 820,000 people across North America.
The current treatment landscape for vitiligo is limited. Only one approved topical immunosuppressant is currently available to patients in the US and Europe, and it is restricted to those with vitiligo on less than 10% of their body surface area who have previously failed transdermal formulations.
SCENESSE® represents a potential breakthrough as a systemic therapy option, with Clinuvel focusing its clinical development on adolescents and adults with darker skin types who face the most significant impact from the condition.
Strategic Market Positioning
Clinuvel's approach extends beyond clinical development to establishing the necessary infrastructure for potential market entry. The company is building relationships with dermatologists across North America, creating a distribution network in anticipation of potential regulatory approval.
Following the completion of CUV105, Clinuvel plans to proceed with a second large trial, CUV107, to further evaluate SCENESSE® in vitiligo treatment. The company continues regulatory discussions in Europe, Africa, and North America to advance its development program.
With a current market capitalization of A$580.9 million, Clinuvel is positioning SCENESSE® as a potential first-in-class systemic repigmentation therapy for vitiligo, addressing a significant unmet need in dermatological care.
