Clinuvel commences US Phase III trial of SCENESSE in rare light and UV disorder
US registration study in erythropoietic protoporphyria (EPP) underway
Clinuvel Pharmaceuticals Limited announced that it has commenced its confirmatory Phase III US study of the novel drug SCENESSE® (afamelanotide) in patients diagnosed with the rare light intolerance disorder erythropoietic protoporphyria (EPP). The six-month, randomised, multicentre, double-blind, placebo-controlled study (CUV039) will recruit up to 100 adult EPP patients in seven specialist centres (Alabama, California, Michigan, New York, North Carolina, Texas and Utah).
The US Food and Drug Administration (FDA) allowed the trial to proceed earlier this month. It is expected that the treatment of all patients will be completed before the end of 2012.
“This Phase III trial protocol has been designed in close consultation with the FDA,” Clinuvel’s Chief Scientific Officer, Dr Hank Agersborg said. “We anticipate that the results will confirm the safety and efficacy profiles seen in previous trials and enable us to file a New Drug Application (NDA) for the drug in the US.
“Clinuvel is working with all study sites to facilitate recruitment of patients during early summer. This period of the year is a particular burden to EPP patients who are prone to incur severe skin reactions when exposed to sunlight,” Dr Agersborg said.
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