Clinuvel's afamelanotide to commence US patient trials for absolute light intolerance
An Australian drug to protect patients who are intolerant of light and sunlight will begin trials in the US next month. 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 diagnosed with the rare 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.
As a result, EPP patients spend most of their lives indoors and lead a secluded life. Sunscreens are of no use in this disease as they don’t block out visible light (in the blue spectrum), which is the cause of toxic reactions in EPP.
Clinuvel has spent over A$70 million the past 10 years developing afamelanotide as the world’s first 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.
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