Clinuvel to Commence US Patient Trials

An Australian drug to protect patients who are intolerant of light and sunlight will begin trials in the US. The US Food and Drug Administration (FDA) has given clearance to Melbourne’s Clinuvel Pharmaceuticals to commence a Phase II study (CUV030) of its drug, afamelanotide, in up to 60 patients who are diagnosed with the light intolerance erythropoietic protoporphyria (EPP).

The six month study, to be conducted in medical centres in Alabama, California, New York, North Carolina, Texas and Utah, is the first therapeutic trial of afamelanotide in the US.

Clinuvel has spent over A$70 million (US$65 million) developing afamelanotide as a photoprotective drug, which works to activate a barrier of pigmentation (melanin) between light and a person’s skin. The implantable drug, the size of a rice grain, is able to stimulate and increase skin pigmentation in fair- skin patients who are less protected from UV damage.

Afamelanotide has been administered to over 500 patients to date in clinical trials in Europe and Australia, with preliminary Phase III results showing good safety and first signs that EPP symptoms can be prevented.