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news.Clinuvel Pharmaceuticals has commissioned an immediate start to Phase II trials to test its drug CUV1647 as a preventative for sun damage and actinic keratosis, which forms a precursor to skin cancer.
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The trial will evaluate the drug’s ability to reduce the incidence of actinic keratosis (AK) and irreversible skin damage in immune-compromised organ transplant patients.
The primary endpoint is to determine the effect of CUV1647 on the number of AKs on the head, back of hand and forearms during a 24-month test period. The secondary endpoint is to determine the effect of CUV1647 on the number of squamous cell carcinomas on the head, back of hand and forearms during a 24-month test period.
CUV1647 stimulates the natural production of melanin, the natural pigmentation of the skin that protects skin from ultraviolet (UV) damage.
Philippe Wolgen, managing director of Clinuvel, said: “Our drug could serve larger patient populations if we are able to prove that melanin protects fair-skinned organ transplant patients against UV and sun damage. In the meantime, we focus on advancing the development of CUV1647 as a photo-protective drug in Phase III trials for the absolute sun intolerance disease EPP and the seasonal sun poisoning skin disease PLE.”