CLINUVEL has announced it will start treatment of vitiligo patients with its drug afamelanotide under a new study protocol (CUV104).
The company said it has received a positive review from the Institutional Review Board (IRB) to commence the CUV104 study. The study will be conducted at a North-American vitiligo expert centre.
Up to six adult vitiligo patients with darker skin complexions (Fitzpatrick Skin Types IV-VI) will be enrolled in the CUV104 study, evaluating patients’ response to afamelanotide as a monotherapy over six months.
“We are thrilled to start this study, as we have seen the efficacy of afamelanotide in vitiligo in earlier studies and now we are all anxious to learn the effect of the drug as a monotherapy,” said CLINUVEL's director of North American Operations, Dr Linda Teng.
“Visible and beneficial effects from the drug as a single therapy would be a leap forward for these patients, as our hormonal solution would be the most biological answer to a stigmatising disorder.”
Vitiligo is a depigmentation disorder characterised by the chronic and progressive loss of functional epidermal melanocytes, which often leads to disfiguration and psychosocial distress. The precise cause of vitiligo remains unknown.