|Melbourne, Australia, 20 October 2022||ASX:
ADR Level 1:
- First vitiligo patient enrolled in CUV104 study
- Afamelanotide evaluated as first systemic monotherapy in vitiligo
- Study to enrol up to six patients with darker skin complexions (Fitzpatrick IV-VI)
- Endpoint: facial repigmentation
CLINUVEL today announced that the first patient has been enrolled in a new clinical study (CUV104), evaluating the safety and efficacy of afamelanotide as a monotherapy in vitiligo patients with darker skin complexions (Fitzpatrick Skin Types IV-VI).
“Vitiligo patients lose skin pigment, creating irregular white patches across the body surface and the disease often has the most severe impact on patients with darker skin types, who report a loss of identity as the skin visibly changes,” CLINUVEL’s Director of North American Operations, Dr Linda Teng said. “Afamelanotide, which is based on a natural hormone, is shown to improve the pigmentary response in vitiligo. It is generally thought that afamelanotide will serve as a pigmentary booster to vitiligo patients, improving their overall response without the need for immunomodulation. Afamelanotide is a systemic treatment being evaluated in vitiligo.”
“We expect to enrol all patients and complete the treatment phase of this study by mid-2023, with results later in the year,” Dr Teng said.
Afamelanotide as Vitiligo Therapy
Vitiligo is a depigmentation disorder characterised by chronic and progressive loss of functional epidermal melanocytes (the melanin producing skin cells), which can lead to disfiguration and psychosocial distress. The precise cause of vitiligo remains unknown.
There is no effective systemic treatment to date, however phototherapy is uniformly used by dermatologists worldwide. In July 2022, an immune modulating topical drug was approved by the FDA as the first commercial therapy in vitiligo.
Afamelanotide has been shown to repigment skin faster and more extensively as combination with narrowband UVB (NB-UVB) phototherapy, and is now being evaluated for its ability to boost the pigmentary response as monotherapy. A successful approach will eliminate or reduce the need for concomitant therapies that require prolonged exposure to ultraviolet light and/or long-term local or systemic immunotherapies.
CLINUVEL has announced an adaptive regulatory pathway for developing afamelanotide as the first systemic therapy for vitiligo patients, with late-stage studies to be conducted over the next 30 months. Pending regulatory discussions and clinical results, the use of afamelanotide as both a monotherapy and combination therapy with NB-UVB will be pursued.
“Following an evolution in regulatory thinking, afamelanotide is well positioned to revolutionise the approach to vitiligo therapy,” Dr Teng said. “Most dermatologists already deploy escalation approaches and we expect that afamelanotide will become the first-line treatment for a great percentage of patients, either as a monotherapy or combination therapy.”
The CUV104 study will enrol up to six adult vitiligo patients with darker skin complexions (Fitzpatrick skin types IV-VI) and vitiligo lesions present on their face. Patients will be treated with SCENESSE® every two weeks for three months, with a three-month follow-up, in expert vitiligo centres in North America. In earlier studies of afamelanotide, patients with darker skin complexions experienced a significantly greater pigmentary response to treatment.
Due to their prominence, facial lesions are recognised as having the greatest impact on many patients’ quality of life, with successful repigmentation of these lesions widely recognised as providing considerable clinical benefit to patients.
Results from the CUV104 study will be discussed with regulatory authorities and help determine the next steps in CLINUVEL’s vitiligo program.