Five month study follow up shows SCENESSE combination treatment provided stable repigmentation in vitiligo patients
Clinuvel Pharmaceuticals Limited announced follow up results from its study of the drug SCENESSE® (afamelanotide 16mg) as a combination therapy with narrowband ultraviolet B (NB-UVB) in the pigmentary disorder Vitiligo. Analysis from the study (CUV102) showed that repigmentation achieved in vitiligo patients who had received combination therapy with SCENESSE® and NB-UVB had proven stable for 11 months since the start of the treatment. Final efficacy results were published on December 19 2012.
In total, 41 patients (75.9%) of the 54 recruited for this trial had completed the treatment at Day 168 and 35 patients (64.8%) had presented for follow up at Day 336. Total body pigmentation at the completion of the treatment period (Day 168) was compared to Day 336 using the VASI scale (a standard clinical measurement for vitiligo).
Repigmentation of vitiliginous lesions in patients who had received the combination treatment of SCENESSE® together with NB-UVB was higher at each time interval (Days 224-280-336) than the NB-UVB group alone (respectively p=0.025; 0.037; 0.032, CI 95%).
Of clinical significance were the results found in patients with darker skin complexion (Fitzpatrick skin types IV-VI). Although vitiligo affects patients of all skin types, those with darker skin complexion are often the most stigmatised due to the visible contrast between vitiligineous lesions and dark skin. Analyses of VASI scores at days 224, 280 and 336 in patients with skin types IV to VI showed that the combination therapy was more effective than NB-UVB alone (respectively p= 0.049; 0.049; 0.047, CI 95%).
At the final follow up visit at Day 336, the safety of the combination therapy was assessed and no significant treatment-related adverse events were reported by either patients or physicians. All patients who received SCENESSE® reported at follow up visit that it had been well tolerated.
Clinuvel expects an Asian Phase IIb study of SCENESSE® in vitiligo will to commence before the end of 2013, subject to regulatory approval.
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