Clinuvel Pharma claimed that it had to develop new study methodology along with EPP experts to be able to evaluate Scenesse, in this 12 month European and Australian study, as a protective treatment.
Clinuvel’s study results showed that treatment with Scenesse has reduced the average daily pain severity scores experienced by EPP patients compared to placebo and also allowed patients to expose their skin to sunlight and spend more time outdoors.
Biolcati, head of the Italian Porphyria Centre at San Gallicano Dermatology Institute, IFO, in Rome, said: “Since commencing treatment with Scenesse, we have seen improvements in EPP patients’ abilities to lead normal lives, without fearing pain during exposure to the sun.”
Hank Agersborg, chief scientific officer of Clinuvel, said: “Scenesse has potential to help those patients with a genuine medical need for protection from UV and light.”
Philippe Wolgen, CEO of Clinuvel, said: “We are confident of being able to present an adequate dossier for regulatory review.”