Scenesse afamelanotide: Phase IIa data
Top-line data from the open-label, U.S. Phase IIa CUV102 trial in 41 evaluable patients with generalized vitiligo showed that 4 doses of monthly 16 mg subcutaneous Scenesse plus thrice-weekly narrow-band ultraviolet B (NB-UVB) light met the co-primary endpoints of improving VASI and VETF scores from baseline to 6 months vs. NB-UVB alone (p=0.025 and p=0.023, respectively). Scenesse plus NB-UVB non-significantly improved median time to first repigmentation, a secondary endpoint, vs. NB-UVB alone (43 vs. 68 days, p=0.086). In a subgroup of patients with darker skin types (Fitzpatrick skin types IV-VI, n=24), Scenesse plus NB-UVB light also significantly improved VASI scores vs. NB-UVB alone (p=0.037). Scenesse was well tolerated with no treatment-related serious adverse events reported. Clinuvel expects to report 6-month follow-up data from CUV102 in mid-2013. The company said the earliest a Phase IIb trial of Scenesse in vitiligo would start is in mid-2013. ...