Clinuvel set to accelerate phase III study of Scenesse

Clinuvel (ASX:CUV) CEO Dr Philippe Wolgen has detailed to shareholders some of the recent strides taken in the US on the road to developing photoreceptive drug Scenesse.

In an investor bulletin, Wolgen said the company last month reached an in-principle agreement with the FDA to accelerate the final phase III study of Scenesse in patients with erythropoietic protoporphyria (EPP).

The company now expects to commence the trial in May. The randomised, double blind, placebo-controlled study will involve some 75 patients in up to seven centres. Patients will receive three Scenesse or placebo implants over a the six-month trial period.

“The FDA discussion was conducted in a most professional and pleasant fashion,” Wolgren wrote in the bulletin.

“I was surprised on the day by the level of acceptance of Scenesse, the support from the agency to finalise the development in US EPP patients as well as the appraisal expressed to have developed a remedy for these patients.”

He said that gaining such regulatory acceptance is a testament to the company's emphasis on product safety.

Scenesse is a subdermal injectable designed to mimic the body's natural ability to create skin treatment melanin. It is being developed to treat EPP as well as vitiligo. Its INN designation is afamelanotide.

EPP is a rare genetic disease characterized by severe phototoxicity of the skin. Symptoms include intolerable pain, swelling and scarring - typically in exposed areas.

Wolgen informed shareholders that the FCC has recently made public a series of videos from a discussion involving FCC members, two EPP sufferers and Dr Robert Desnick about the condition.

The two patients, Mike Kenworthy Ph D and Matt Johnson, were involved in a recent phase II study of Scenesse to treat EPP, and Desnick was the principal investigator in the trial.

Kentworthy and Johnson detailed living with the condition, associated complications and the ineffectiveness of alternate treatments including beta carotene or sunscreen.

Wolgen also revealed that the company expects to provide further results from the treatment stage of a separate trial of Scenesse in conjunction with narrow band UVB light therapy in patients with the skin pigmentation disorder vitiligo.

The trial has already yielded some positive clinical results, Wolgen said.

Clinuvel (ASX:CUV) shares stayed flat at $1.76.