CLINUVEL (ASX:CUV) Completes Phase III Vitiligo Trial Recruitment
Study Details
CLINUVEL has met its recruitment target of 200 patients for its Phase III vitiligo trial, CUV105, evaluating SCENESSE® (afamelanotide 16mg). The randomised trial includes a 20-week treatment protocol followed by a six-month follow-up and is conducted across 37 sites in North America, Africa, and Europe. First results are anticipated in the second half of 2026.
Clinical Observations
Initial clinical observations from CUV105 have been positive, with four case studies demonstrating repigmentation of vitiligo lesions after four weeks of SCENESSE® treatment. A fifth case study showcased a 46-year-old male with a 20-year history of vitiligo exhibiting repigmentation on his arms and legs. All patients reported satisfaction and tolerance of the treatment.
Executive Comments
CLINUVEL’s Director, Global Clinical Affairs, Dr Emilie Rodenburger, said, “We are thrilled with this enrolment milestone since we are essentially establishing a North American distribution network among dermatologists, anticipating the necessary infrastructure ahead of market entry of our breakthrough product. The first clinical observations of the systemic (total body) solution are encouraging, and now we will continue a regulatory discussion in Europe, Africa and North America, all in anticipation of CUV107, a second large trial evaluating the treatment effects of SCENESSE® in vitiligo.”
Motley Fool contributor Abbie Stokes has no position in any of the stocks mentioned. The Motley Fool Australia's parent company Motley Fool Holdings Inc. has no position in any of the stocks mentioned. The Motley Fool Australia has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.
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