Scenesse afamelanotide: Phase III data

Twelve-month data from the double-blind, crossover, Australian and European Phase III CUV017 trial in 91 patients showed that Scenesse significantly reduced the total number of days in which patients experienced pain associated with phototoxicity and significantly reduced average overall daily pain severity scores vs. placebo (p=0.0023 and p=0.0017, respectively). In patients willing to undergo continuous exposure to sunlight, Scenesse non-significantly reduced average pain scores vs. placebo (p=0.1654). Pain scores were measured using an 11-point Likert Pain Scale and physician assessments of phototoxicity and skin lesions through case report forms. Scenesse was well tolerated with no serious adverse events reported. Patients received alternating 16 mg Scenesse or placebo implants every 2 months for 12 months. Data will be presented at the European Association for Dermatology and Venereology meeting in Gothenburg in October. ...