Study shows Scenesse (Clinuvel Pharma) offers benefits for EPP

Analyses of a Phase III US study (CUV039) evaluating the administration of Scenesse (afamelanotide), from Clinuvel Pharmaceuticals, to patients diagnosed with Erythropoietic Protoporphyria (EPP) show a clinically meaningful treatment effect. The drug was well tolerated with no safety concerns identified. The study's independent Data Safety Monitoring Board stated that the drug treatment offered had been clinically meaningful and safe for use in patients. Endpoint analysis shows strong trend that treated patients were able to experience more pain-free sun exposure between 10:00 and 18:00; median total direct sunlight exposure was 64.13 hours in the active group compared with 47.5 hours for placebo-recipients.

Photoprovocation, an objective measure of light tolerance, showed that Scenesse significantly increased time to first symptoms following light provocation. In addition, recipients showed significantly improved QoL scores in comparison to placebo recipients on days 60, 120 and 180 of the study. The EMA will include CUV039 data as part of the ongoing marketing authorisation application.