Melbourne, Australia-based Clinuvel Pharmaceuticals has achieved positive interim results with its photoprotective drug, afamelanotide, in a Swiss Phase III trial in the orphan disease erythropoietic protoporphyria (EPP), a severe genetic disorder causing absolute ultraviolet radiation and light intolerance in the skin.
The results showed that the maximum severity of phototoxic reactions for patients on the drug was significantly reduced compared to those on placebo (p<0.001). The total severity of phototoxic reactions was lowered 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 result showed a statistically-significant reduction in the severity of phototoxic reactions in EPP patients and increased melanin density in the skin.
Patients requested compassionate use of drug
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