Clinuvel reports that afamelanotide (Scenesse) continues to be promising in a small 2nd trial conducted in Singapore
Posted On: Monday, January 04, 2016
John E. Harris
Vitiligo, Vitiligo Research, Vitiligo Treatment
I previously blogged about a trial conducted in the US to test the ability of afamelanotide (Scenesse) to improve the response of vitiligo patients to narrow band UVB (nbUVB). You can read that post here. Briefly, the drug is made by Clinuvel and stimulates melanocytes, the pigment-making cells of the skin, to regrow and help the pigment to return. Scenesse is approved in Europe for the treatment of porphyria, a disease in which patients are very sensitive to sunlight, and it works by making the skin darker through a process similar to tanning, but without exposure to the sun. In the US trial, vitiligo patients treated with afamelanotide plus nbUVB had faster and better repigmentation of their skin compared to those who received placebo plus nbUVB, and this seemed to occur more frequently in those with darker skin types. Side effects included nausea and tanning of the skin, which is often a concern for vitiligo patients because it makes the white spots more obvious before they get better.
More recently, Clinuvel conducted a smaller clinical trial at the National Skin Center in Singapore, and a preliminary report states that the 4 subjects who received 6 monthly doses of Scenesse plus nbUVB had a better response than 3 subjects who received nbUVB alone, although the difference did not yet reach statistical significance due to the small number of subjects (p = 0.052). More subjects are still receiving the treatment, and full results are expected in early 2016. They have not yet released photos of enrolled subjects, the full report is available here. This trial enrolled only subjects with darker skin types, based on the more promising results in this population observed in their US trial, and also the fact that patients in Singapore frequently have darker skin. They did not test the drug on its own without nbUVB, and most believe that it will probably not be effective on its own. But nbUVB treatment for vitiligo is time-consuming, requiring 12-18 months to be effective, and so a drug like Scenesse that speeds and improves the response could be a real improvement to conventional approaches.
Dr. Emilie Rodenburger, Director of Clinical Affairs at Clinuvel, was optimistic about these results: “From the encouraging results in two Phase II studies in the US and Singapore, and our ongoing safety program, we are confident that we have sufficient data to optimize the further development of SCENESSE® in vitiligo in specific populations.” Based on the two studies, the company states that “advanced vitiligo trials are planned in North America”, although when and where the studies will be conducted, and exactly what types of vitiligo patients they will be looking for, is not known at this time. They are currently working with the FDA to fulfill all of the requirements necessary to get approval for the use of Scenesse in vitiligo patients. Keep an eye on our site and subscribe to updates if you’re interested in getting news as it becomes available and for hearing about the latest in clinical trials.