Clinuvel starts final trial of Scenesse in EPP

Clinuvel Pharmaceuticals (ASX:CUV) has commenced a final US phase III trial of its Scenesse drug in patients with rare light intolerance disorder erythropoietic protoporphyria (EPP).

The six month trial will recruit up to 100 sufferers of EPP across seven specialist centres across the US. It will be randomised, double-blind and placebo-controlled.

The US FDA cleared Clinuvel to conduct the study earlier this month, after reaching an in-principal agreement to allow the company to accelerate the trial process in April.

EPP is a rare genetic disease characterised by extreme intolerance to light and UV exposure. Symptoms can include intolerable pain, swelling and scarring – often in exposed areas.

It is also associated with complications including liver diseases, due to a build-up of protoporphyrin in the body.

Scenesse, or afemelanotide, is designed to increase the levels of melanin in the skin in order to shield against UV radiation and sunlight. It achieves this via naturally occurring peptide hormone Alpha-Melanocyte Stimulating Hormone. Scenesse is delivered via a subdermal implant.

Clinuvel has already conducted two Phase III trials of Scenesse in EPP patients, with subjects reporting reduced frequency and severity of pain caused by exposure to light.

The latest confirmatory trial forms part of Clinuvel's preparations for a new drug application with the FDA for Scenesse.

Clinuvel was granted orphan drug status for Scenesse as an EPP treatment by both the FDA and the European Medicines Agency (EMA) in 2008. And in February, the company filed for marketing approval for Scenesse with the EMA.

The company is also trialling the drug as a treatment for more skin conditions including Vitiligo.

Clinuvel (ASX:CUV) shares were trading 5.59% higher at $1.700 as of 2:30pm on Wednesday.