Clinuvel's Scenesse being trialled in HHD

Clinuvel Pharmaceuticals (ASX:CUV) has announced the launch of a clinical trial evaluating its Scenesse dermal implant in the rare skin disorder Hailey-Hailey Disease (HHD).

A physician-led phase II trial of Scenesse has commenced in Italy. The investigators aim to treat 10 HHD patients with 12 doses of Scenesse over the course of one year. Recruitment is expected to be complete by March.

HHD is a rare genetic disorder whereby epidermal skin cells known as keratinocytes cannot properly adhere. This causes periodic, often permanent, eruption of plaque-like legions, blisters and ulcerations on areas where skin folds, including the neck, armpits or groin.

Scenesse is a dermal implant designed to deliver a 16 mg dose of afamelanotide to the skin. It is under development for skin conditions including erythropoietic protoporphyria (EPP) and vitilgo.

The phase II trial of Scenesse in HHD follows on from the first proof-of-concept pilot trial in 2012.

During this study, two HHD patients with long-lasting lesions and ulcerations were treated with Scenesse. Their lesions disappeared after day 60 and only started to reappear eight months after the completion of treatment.

“We are pleased with the results of the pilot study and look forward to the outcome of this longer-term study,” Clinuvel acting Chief Scientific Officer Dr Dennis Wright said. “We hope that afamelanotide provides a major therapeutic breakthrough for HHD patients who do not have any effective treatment.”

Clinuvel (ASX:CUV) shares were trading unchanged at $1.45 as of around 2 pm on Monday.