Clinuvel data show SCENESSE accelerates repigmentation

By Dylan Bushell-Embling
Tuesday, 16 October, 2012

The first published data from Clinuvel's (ASX:CUV) trial of SCENESSE in patients with skin condition vitiligo indicate that the treatment can help accelerate repigmentation of the skin.

Case studies of four of the 56 patients enrolled in the phase IIa open label trial have been published in the international journal Archives of Dermatology.

During the trial patients with vitiligo were treated with narrowband UVB light therapy for six months in addition to four doses SCENESSE, to help determine whether the combination of treatments can safety accelerate repigmentation.

The four patients featured in the case studies showed 50% to 90% overall repigmentation within the six-month treatment period.

At three-month follow up, the three patients with darker skin types showed now relapse of their repigmentation, while the lighter-skinned patient saw a 10% relapse. Reported adverse events were limited to fatigue, nausea, headache and dizziness.

All 56 patients from the trial will attend a six-month follow up consultation to assess the stability of their repigmentation, and these data will be included in the final results.

SCENESSE, or afemalenotide, is a photoreceptive drug designed to increase the levels of melanin in the skin and shield against sunlight and UVR.

It is also being developed for more targets, including the rare skin condition erythropoietic protoporphyria (EPP). Clinuvel in May commenced a phase III trial in EPP to accompany its New Drug Application with the US FDA. Clinuvel has also filed for marketing approval for the drug in Europe.

Clinuvel (ASX:CUV) shares were trading 0.62% higher at $1.620 as of 3:45pm on Tuesday.

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