CLINUVEL (ASX:CUV) has announced final results from its Phase 2 pilot study evaluating SCENESSE (afamelanotide) as a monotherapy in patients with the depigmentation disorder vitiligo.
The company stated that the single-arm, open-label study failed to demonstrate repigmentation in the skin of three adult vitiligo patients treated with SCENESSE as monotherapy for up to three months. It said SCENESSE was well tolerated at a high dose of six implants administered at 14-day intervals.
The lack of repigmentation observed in patients with CUV104 illustrates the utility of adjunctive narrowband ultraviolet B (NB-UVB) phototherapy for treating vitiligo patients with afamelanotide, according to CLINUVEL.
“We now have clinical evidence supporting our scientific hypothesis that afamelanotide requires concomitant activation of pigment-producing cells by NB-UVB to effectively repigment vitiligo patients,” said CLINUVEL’s Director of Global Clinical Affairs, Dr Emilie Rodenburger.
“These data confirm the Company’s decision to pursue afamelanotide and adjunct NB-UVB as part of its pivotal study designs, while at the same time addressing regulatory questions as to the effects of afamelanotide as monotherapy.”
CLINUVEL said no further studies are planned to evaluate afamelanotide as monotherapy for vitiligo patients. Its ongoing CUV105 Phase 3 study and planned CUV107 pivotal Phase 3 study are evaluating SCENESSE as a systemic repigmentation therapy with adjunct NB-UVB.
“The CUV104 results have once and for all confirmed our thinking and expertise that vitiligo cannot be treated with a single modality. We are making clinically meaningful steps towards offering vitiligo patients with darker skin complexions a treatment derived from our natural pigmentation hormone,” said Dr Rodenburger.