Clinuvel Pharmaceuticals (ASX:CUV) has announced it has fulfilled the FDA requirement to demonstrate safety in a pre-clinical model prior to progressing further with the clinical development of the combination therapy of its drug SCENESSE (afamelanotide 16mg) and narrowband UVB (NB-UVB) light in the pigmentation disorder vitiligo.
Clinuvel said it has completed one US Phase 2 clinical trial of SCENESSE in vitiligo patients (CUV102), with a second study (CUV103) underway in Singapore. In both studies the drug has been used in combination with NB-UVB light to evaluate its safety profile and ability to repigment skin in vitiligo patients.
The company said results of CUV102 and preliminary results in CUV103 show that SCENESSE in combination with NB-UVB light administered twice or three times weekly had a good safety profile, and the optimal effectiveness of the combination was identified in patients of darker skin complexion (Fitzpatrick skin types IV, V and VI).
The FDA communicated to Clinuvel that – prior to pursuing later stage clinical trials and seeking marketing authorisation for SCENESSE in vitiligo in the US – the company would need to demonstrate the safety of the drug in combination with NB-UVB light, simulating the proposed human dose regimen in a pre-clinical model.
Now that the requirement has been completed, Clinuvel said it will request a guidance meeting (Type C) with the FDA to discuss the next clinical trial in vitiligo patients in North America.