Positive results from Clinuvel's US Phase II study of photoprotective drug, afamelanotide

Clinuvel Pharmaceuticals LimitedNov 3 2011

Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY), a global biopharmaceutical company with unique expertise on the interaction of light and human skin, today announced positive results of its first US Phase II study of the novel photoprotective drug afamelanotide, known as SCENESSE®.

“This clinical study indicates the effectiveness of the drug in preventing the severe pain resulting from sun exposure. This is important for patients as it is the first treatment for EPP that will improve their now limited quality of life.”

The six-month, randomised, multicentre, double-blind, placebo-controlled US study (CUV030) was primarily designed to confirm the efficacy and safety of subcutaneous bioresorbable afamelanotide implants (SCENESSE®) in reducing the severity of phototoxic skin reactions in patients with the rare light intolerance disorder erythropoietic protoporphyria (EPP), allowing them to lead 'more normal' lives.

Commenting on the results, Dr Robert J Desnick, Dean for Genetic and Genomic Medicine and Professor and Chairman Emeritus of the Department of Genetics and Genomic Sciences at Mount Sinai School of Medicine, New York and a lead investigator on the CUV030 study, said, "This clinical study indicates the effectiveness of the drug in preventing the severe pain resulting from sun exposure. This is important for patients as it is the first treatment for EPP that will improve their now limited quality of life."

Clinuvel's CEO, Dr Philippe Wolgen, said, "We are pleased with the outcome of this trial as it adds to the mounting body of evidence that afamelanotide is effective as a prophylactic treatment for EPP in the clinic and allows a better quality of life to those who suffer from a terrible disorder which is not well understood by the general public. SCENESSE® acts as a protective umbrella for the ultra light sensitive skin of these patients, and enables them to participate in a life they have never known before. Proposing a new pharmaceutical therapy which is safe and clinically relevant to EPP patients is Clinuvel's most important objective, since we will be expected to demonstrate a positive risk-benefit ratio as part of our European regulatory submission later this year."