Scenesse misses in Phase III trial for genetic skin disorder

Clinuvel Pharmaceuticals Ltd. (ASX:CUV; Xetra:UR9) said three doses of subcutaneous Scenesse afamelanotide ( CUV1647) given every two months missed the primary endpoint in the 93-patient Phase III CUV039 trial to treat erythropoietic protoporphyria (EPP), a severe genetic disorder causing absolute ultraviolet radiation and light intolerance in the skin. Scenesse did not increase the median total duration of pain-free direct sunlight exposure between 10:00 and 18:00 hours as recorded by patient diary from baseline to six months vs. placebo (64.1 vs. 47.5 hours, p=0.107), though Clinuvel said there was a "strong statistical trend in pain-free exposure." Scenesse also did meet the secondary endpoints of improving quality of life scores at days 60 (p=0.002), 120 (p=0.002) and 180 (p=0.004) vs. placebo. ...