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Clinuvel reported results from a phase II trial of afamelanotide for the treatment of Erythropoietic Protoporphyria (EPP). The randomized, double-blind, placebo-controlled study (CUV030) enrolled 77 subjects, 68 of whom completed the trial. The subjects were administered either the afamelanotide implant or placebo at the start of study, after 60 days and 120 days, and were followed up to 180 days. The primary endpoint was to determine whether afamelanotide implants can reduce the severity of phototoxic reactions associated with EPP. Based on analysis of time spent outside, afamelanotide was shown to increase subjects ability to expose their skin to direct sunlight compared to placebo. The subjects who received afamelanotide spent significantly more time in direct sunlight between the most intense hours of 10 AM and 3 PM (p≡0.036) and between 10 AM and 8 PM (p≡0.025). Data from an EPP-specific quality of life assessment also demonstrated an improvement from baseline for subjects receiving afamelanotide compared to placebo at 60 days (p≡0.001), 120 days (p≡0.003) and 180 days (p<0.001). The afamelanotide implant was safe and well-tolerated.
Clinuvel issued positive interim results from a phase III trial of afamelanotide for the treatment of erythropoietic protoporphyria (EPP). To date, this randomized, placebo-controlled trial had enrolled 14 subjects who received 16 mg implants of the drug. The primary endpoints are reduction in the number and severity of phototoxic skin reactions. The results showed that the maximum severity of phototoxic reactions for subjects on the drug was significantly reduced compared to those on the placebo (p<0.001). In addition, the total severity of phototoxic reactions was reduced during spring and summer by afamelanotide, compared with placebo (p≡0.028). No drug related serious adverse events were observed. Based on the data, Clinuvel plans to continue with the study as planned; full results are expected by the end of 2009.