Clinuvel Pharmaceuticals Ltd (ASX:CUV) has fulfilled an important FDA requirement by demonstrating the safety of its drug SCENESSE in combination with ultraviolet light for the pigmentation disorder vitiligo.
The company will now engage with the FDA regarding the upcoming vitiligo trials and progress clinical development of the combination therapy.
Clinuvel had completed one Phase II clinical trial of SCENESSE in vitiligo patients in the U.S., with a second study underway in Singapore.
In both studies, the drug has been used in combination with narrowband ultraviolet B light to evaluate its safety profile and ability to repigment skin in vitiligo patients.
The results of the studies show that the combination had a good safety profile and delivered optimal outcomes in patients with darker skin complexion.
Now that the requirement has been completed, Clinuvel will request a guidance meeting with the FDA to discuss the next clinical trial in vitiligo patients in North America.
The progress for Clinuvel in the U.S. follows the commercial launch of SCENESSE in Europe in June.
SCENESSE was accepted as a specialty hospital product in Netherlands for treating erythropoietic protoporphyria, a disease which causes severe skin burns from exposure to light.
The company had $13.8 million in cash as at 30 June 2016.
Clinuvel’s share price has increased by about 75% during the last 6 months.
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