Clinuvel Announces PLE Phase III Preliminary Results

Clinuvel Pharmaceuticals has obtained preliminary results in its multi-center randomized double-blind placebo controlled PLE study (CUV015) for evaluating the safety and efficacy of afamelanotide 20 mg implants.

PLE is a recurrent seasonal UV-related skin disorder that is seen mostly in fair-skinned patients (10-20 percent incidence) in the northern hemisphere.

Preliminary evaluation of 36 patients with recurrent PLE revealed a trend toward reduction of characteristic dermal symptoms. Analysis of the physician's Global Severity Index during the 120 days and 150 days of seasonal treatment demonstrated a reduction in severity of symptoms in patients receiving afamelanotide compared to placebo (p=0.448 and p=0.077).

In all sun exposed areas of the skin that were tested, compared to starting values, an increase in melanin density was found at 120 days (p=0.009) and 150 days (p=0.007) indicating a strong elevation in melanin density in phototype I and II patients during spring and summer. Overall the safety profile of afamelanotide administered during the trial was good.

Positive reports from leading academic dermatologists in the trial form the basis for the further testing of afamelanotide 16 mg as final commercial product. A two-dose randomized placebo-controlled Phase III trial (CUV032) over the seasons (March-October 2010) will be conducted, and 40-50 Caucasian patients with severe and recurrent PLE are currently being selected in five European academic centres. All data from this study and other trials that are currently in progress will further support the final registration dossier of afamelanotide in erythropoietic protoporphyria (EPP) and solar urticaria (SU) in Europe and Australia.