|Melbourne, Australia,20 December 2021||ASX:
NASDAQ INTERNATIONAL DESIGNATION:
- FDA agrees to Phase II study CUV104 evaluating SCENESSE® as vitiligo monotherapy
- Patients with darker skin types (Fitzpatrick IV-VI) to be enrolled in study CUV104
- Repigmentation, Quality of Life to be evaluated
CLINUVEL’s drug SCENESSE® (afamelanotide 16mg) will be evaluated as a monotherapy in patients with the depigmentation disorder vitiligo, in a six month clinical trial (CUV104). The Company has reached agreement on the clinical protocol and will commence the CUV104 study at a specialist hospital department in the USA.
Protocol Design and US FDA Input
Several meetings have been held with the US Food and Drug Administration (FDA) over the past years, whereby global clinical experts have accompanied CLINUVEL to discuss clinical study protocols in vitiligo. The main discussion point concerned the proposed administration of SCENESSE® in combination with narrowband ultraviolet B (NB-UVB) phototherapy in pivotal studies to support a US New Drug Application.
Vitiligo causes progressive loss of pigmentation in “lesions” across the body and affects around 1% of the population worldwide. Treatment aims to halt the spread of depigmentation and repigment the affected skin. NB-UVB – administered as an off-label (unapproved) treatment in vitiligo – does provoke some skin pigmentary response after 6-18 months of therapy, but seldom does it achieve satisfactory levels of repigmentation in vitiligo patients. In the six-month CUV102 study, the combination of SCENESSE® with NB-UVB led to successful repigmentation in patients with darker skin complexions (Fitzpatrick skin type IV, V, VI).1
At the present time, the FDA does acknowledge NB-UVB to be the treatment of choice for vitiligo, and in use by the majority of clinical centres.2 However, the agency has not evaluated nor approved NB-UVB for the treatment of vitiligo. Further, the FDA stated that the safe use of the NB-UVB as a combination therapy (with any other treatment) had not yet been proven for human use.
Currently, there is no effective or FDA-approved therapy for vitiligo patients. Various drug candidates are being tested at present, with some causing undesired long-term immune suppression.
CUV104 Study – Repigmentation, Quality of Life
In the pilot study CUV104, for the first time, the response to SCENESSE® as a monotherapy will be assessed in patients with darker skin complexions.
The study will focus on the extent and speed of repigmentation seen in patients as measured by the Vitiligo Area Scoring Index (VASI) tool, as well as the impact of the treatment, measured with validated disease-specific quality of life tools.
The study will be conducted under an amendment to CLINUVEL’s existing Investigational New Drug (IND) status.
“After several discussions with the FDA and clinical experts, we have found a pathway to offer systemic repigmentation treatment with SCENESSE® to vitiligo patients with darker skin,” CLINUVEL’s Director of North American Operations, Dr Linda Teng said. “It is well acknowledged by the regulatory authorities that the loss of pigmentation in these patients is most dramatic, causing significant psychological distress. If this initial study is successful, we will pursue a larger trial.”