According to the company, Scenesse is the first photoprotective drug developed as a prophylactic treatment for phototoxicity experienced by patients with EPP, a rare light intolerance disease.
CUV029, a randomised placebo-controlled nine month period trial consisted of two parallel treatment arms which recruited a total of 74 EPP patients.
Patients were evenly distributed between the two treatment groups, receiving either afamelanotide or placebo treatment every 60 days.
The study met both the primary and secondary endpoints.
The primary objective of evaluating afamelanotide in EPP patients was to determine whether the prophylactic effect has meaningful clinical benefit.
The secondary objective was to assess the effect of treatment on their Quality of Life (QoL).
Scenesse has been granted orphan drug status both in Europe and the US.
Clinuvel is currently finalising a Marketing Authorisation Application (MAA) for SCENESSE for submission to the European Medicines Agency (EMA).