Confirmatory clinical trial program – Europe
Clinuvel recently announced results from a confirmatory Phase III trial of SCENESSE® (afamelanotide) in patients diagnosed with erythropoietic protoporphyria (EPP) which was conducted in Europe (study CUV029). In this study SCENESSE® was shown to significantly reduce pain associated with phototoxicity and the number of phototoxic reactions. It further enabled patients to experience more direct sunlight exposure without pain and improve their quality of life. Sixty eight (91.9%) of the 74 EPP patients enrolled completed the nine month study which raised no significant safety concerns and demonstrated that SCENESSE® was well tolerated. Patients across the eight study sites were randomly assigned afamelanotide or a placebo every 60 days. You can read the CUV029 study results here.
In February 2012, Clinuvel submitted a marketing authorisation application (MAA) for SCENESSE® (afamelanotide) to the European Medicines Agency (EMA) for the prophylactic treatment of EPP. For more information, see the company's announcement.
