01 October 2018
CLINUVEL PHARMACEUTICALS LTD today announced that it has reached agreement with two European porphyria expert centres on a clinical trial protocol to conduct a Phase IIa proof of concept study evaluating the safety and effectiveness of SCENESSE® (afamelanotide 16mg) in variegate porphyria (VP). The study (CUV040) will start patient treatment in the northern hemisphere spring of 2019.
Currently, SCENESSE® is being prescribed by porphyria experts centres in Europe for the treatment of erythropoietic protoporphyria (EPP), a genetic disorder which causes absolute light intolerance due to a deficiency of ferrochelatase, an enzyme critical in the synthesis of haem. SCENESSE® was granted European marketing authorisation in October 2014.