Clinuvel: Interim Phase III Results for Skin Protection Drug
- Posted on 26 January 2009
Melbourne-based Clinuvel Pharmaceuticals has announced interim results of its photoprotective drug, afamelanotide, in a Phase III trial conducted in Switzerland.
The trial investigated the medical benefits of afamelanotide in the orphan disease erythropoietic protoporphyria (EPP), a genetic disorder causing absolute ultraviolet radiation (UV) and light intolerance in the skin.
The interim results are based on the trial’s first 14 Swiss patients, within a 12-month study period. A further 87 patients will complete the trial in Europe and Australia. The European and Australian Phase III EPP trial is expected to be completed in the second half of 2009.
The results showed that the maximum severity of phototoxic reactions for patients on the drug was reduced compared to patients on the placebo (p<0.001). The total severity of phototoxic reactions was reduced during spring and summer by afamelanotide, compared with placebo (p=0.028).
The patients were tested at higher altitude where ultraviolet radiation is more intense. The results showed a statistically significant reduction in the severity of phototoxic reactions in EPP patients and increased melanin density in the skin.
Clinuvel hopes to file for the drug’s approval in Europe in the next 18 months.
