Clinuvel Pharmaceuticals (ASX:CUV) said the first clinical observations of its CUV105 study of the Scenesse treatment candidate in vitiligo showed repigmentation of vitiliginous lesions on the face, back, arms, or legs following treatment, according to a Wednesday Australian Securities Exchange filing.
Scenesse is a systemic treatment candidate to restore pigmentation in vitiligo. The trial aims to achieve a minimum of 50% repigmentation across a patient's total body surface area. Secondary endpoints include facial measures along with a number of patient-reported outcomes.
All case study patients reported satisfaction with the treatment results and high tolerance to Scenesse with adjunct NB-UVB, per the filing.
The trial, involving 37 clinical sites across the US, Europe, and Africa, concluded recruitment, with 5% more patients enrolled than planned.
The firm expanded its US commercial team and reinforced its supply chain for Scenesse, including the relocation of select manufacturing and distribution operations.
The firm plans to grow its network of 104 trained and accredited specialty centers across North America to 120 centers by the end of the year. It expects the network to be able to facilitate treatment of up to 6,000 vitiligo patients annually within the first two years of commercial rollout.
It completed pricing surveys in North America as part of its commercial planning for vitiligo.
Clinuvel Pharmaceuticals' shares jumped nearly 8% in recent trading on Wednesday.
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