Clinuvel identifies potential new target for Scenesse

Melbourne biotech Clinuvel announced today that it plans to conduct clinical trials of its UV protection drug Scenesse as a treatment for the skin pigmentation disorder vitiligo.

To date the drug has been safely administered to around 550 patients suffering from various light sensitivity related conditions, including heightened UV sensitivity arising from the use of immunosuppresant drugs following organ transplantation.

About two percent of people are affected by Vitiligo, a disorder in which the pigment producing cells of the skin (melanocytes) are absent or inadequate. This results in patches of skin appearing lighter in those parts of the body where melanin is lacking.

"For a long time we were unsure of the potential of the drug in vitiligo," said Clinuvel Chief Scientific Officer, Dr Hank Agersborg. "But, since the scientific reports came through on the effects of phototherapy in vitiligo, we understood Scenese's ability to assist with repigmenting skin lesions."

The active ingredient in Scenesse is afamelanotide, which is a naturally occurring melanocortin peptide hormone. The drug works by mimicking the body's own response to ultraviolet light, activating melanin in the skin to protect against damage. The drug is administered as an injectable implant, similar in size to a grain of rice, which activates melanin for up to 60 days.

Nonsegmental vitiligo (NSV), the most common subtype of vitiligo, affects over 45 million people globally. If approved by European and US regulators Clinuvel said that it expected to commence trials of the drug in sufferers of the disease in October.

The company said that Scenesse will be tested in a pilot NSV study on its own as well as in combination with narrowband ultraviolet B (NB-UVB), an existing therapy which uses UV light to activate pigment and restore melanin producing melanocytes. The company said that it expects Scenese to bolster this therapy while activating melanin independently by stimulating specific melanocytes which exist in hair follicles within the skin.

Scenesse is currently in late stage confirmatory trials in the US and Europe to treat the rare light intolerance disorder erythropoietic protoporphyria (EPP). Italy's health regulator recently approved reimbursement for the drug's use against EPP, becoming the first country in Europe to approve a drug still in clinical phase.

Clinuvel’s shares gained two cents today to close at $0.22.