Clinuvel Pharmaceuticals Ltd., an Australian drug company, said clinical trials showed a drug provided relief for sufferers of a rare disease that makes them sensitive to light.
A 12-month study in eight countries showed Scenesse “significantly” reduced the pain experienced by participants, all of whom suffered from erythropoietic protoporphyria, or EPP, the Melbourne-based company said in a statement today. There were 91 patients in the study, Clinuvel said.
EPP sufferers experience itching, swelling and burning of the skin when exposed to light, according to the American Porphyria Foundation website. EPP also causes abnormally elevated levels of protoporphyrin, a compound which accumulates in the liver and may cause gallstones or other, more severe complications. There’s “no comparable therapy” for the disease, Clinuvel said.
The results “will assist us in making a case to regulatory agencies on the grounds of drug safety, efficacy and need for treatment,” Chief Executive Officer Philippe Wolgen said in the statement.
Scenesse would be the pharmaceutical company’s first marketed product, should it get regulatory approval. There are about 10,000 people who suffer from the disease around the world, Clinuvel said.
The company will present the full results of the phase III trials at the 19th Congress of the European Association for Dermatology and Venereology in Gothenburg, Sweden, in October. Phase III trials are the third and final stage of patient studies usually required for U.S. regulatory review.
Clinuvel shares closed unchanged at 24.5 Australian cents at the end of Sydney’s trading day.