Scenesse: Follow-up to first Phase II Study Very Promising
Repigmentation achieved from an experimental combination treatment using narrowband UVB (NB-UVB) with afamelanotide, a linear peptide that can activate production of melanin in the skin, is reported to be more stable and extensive than that achieved by NB-UVB alone. Results from a five-month follow-up study of this new combination therapy were recently reported by Clinuvel Pharmaceuticals, an Australian company testing the ability of its drug Scenesse (known generically as afamelanotide) to accelerate NB-UVB’s ability to repigment vitiligo.
According to the company, the 41 patients who completed the combination treatment as part of a 6-month Phase II study had more repigmentation at the end of five months following the end of treatment than the group who had been treated with NB-UVB alone. In addition, the repigmentation in the combination group had remained stable since the start of therapy 11 months earlier (6 months of treatment plus five-month follow up period); pigment stability after treatment is often an issue. No significant adverse effects were reported in the combination group by either patients or physicians. At the follow-up, patients said that the treatment was well-tolerated.
The combination therapy group was treated 3 times weekly with NB-UVB for 6 months total; starting in the second month, they received a series of 4 monthly implants containing afamelanotide, followed by a final month of NB-UVB monotherapy. The monotherapy group of patients was treated with NB-UVB alone over the 6-month study period. Repigmentation occurred earlier in those on the combination therapy (median 43 days versus 68 days) and those with the darkest skin complexion achieved a deeper and more complete repigmentation compared to those only being treated with NB-UVB.
The combination therapy potentially offers a way to achieve faster and greater repigmentation and one that can be maintained without continuing treatment. NB-UVB is the most effective treatment currently available for widespread vitiligo. Its combined use with afamelanotide could be the first choice in treatment in the future. According to Clinuvel’s acting Chief Scientific Officer, Dr. Dennis Wright, “These results, together with the earlier efficacy analyses, show that Scenesse has the potential to become the main pharmaceutical agent used in the treatment of vitiligo.”
Clinuvel has announced that it expects to conduct a Phase IIb study of Scenesse in vitiligo in Europe and Asia before the end of 2013, if approved by regulatory authorities.