Trial success sees Clinuvel near European filing for Scenesse

Melbourne biotech Clinuvel has reach another milestone in its drive to have its photoprotective drug Scenesse brought to market with the reporting of a phase III study showing it provides significant benefit for individuals with erythropoietic protoporphyria (EPP).

In light of the results, Clinuvel intends to file for European Marketing Authorisation for EPP.

Read more about Clinuvel and Scenesse.

EPP is a rare genetic disease found mainly in people with fair skin. It is characterised by severe phototoxicity (or intolerance to light) of the skin resulting in intolerable pain, swelling and scarring, usually of the exposed areas such as the face, hands and feet.

The pain experienced and expressed by EPP patients when their skin is exposed to light is reported as intolerable. EPP patients are often forced to remain indoors, severely affecting their quality of life.

Scenesse is delivered via a dissolvable implant that is inserted under the skin and releases afamelanotide, a linear peptide which activates eumelanin of the skin, the dark pigment which is known to provide photoprotective properties.

Individuals who receive Scenesse experience a darkening of the skin similar to tanning. Increased pigmentation of the skin may appear after two days and the therapeutic effect lasts up to two months.

The randomised placebo-controlled trial, which was conducted in eight different countries across Europe, found Scenesse had a significant impact on the quality of life of EPP patients.

Patients receiving the drug reported significantly less pain associated with phototoxicity, had half as many phototoxic reactions and could tolerate direct sunlight for up to seven times longer than those on placebo.

The study also found no serious adverse effects, with the most common being associated with implant administration, transient nausea, headache and the common cold.

“To obtain these results in a relatively small orphan drug population is excellent and supports our imminent submission to European regulators,” said Clinuvel’s Chief Scientific Officer, Dr Hank Agersborg.

“We knew over the years that European patients had tolerated the drug well, and from many patient and physician anecdotes during the study we learned of the clinical benefit of the drug.

“Overall, results from our four EPP studies show that we have made the right decision in our development strategy and it is encouraging to see strong demand for compassionate use by patients who have completed these studies.”

Nomura research has issued a note recommending a target price for Clinuvel of $3.56, adding: “These are excellent clinical trial results, and should be seen positively by regulatory authorities.”

Clinuvel (ASX:CUV) was up 1% to $1.52 in morning trading.