Clinical TrialJul 28, 2026, 06:11 AM
Clinuvel Updates on SCENESSE® Vitiligo Trial Timelines
AI Summary
Clinuvel Pharmaceuticals provided an update on its SCENESSE® (afamelanotide) clinical program for vitiligo patients with darker skin. Topline results for the CUV105 study, which evaluates SCENESSE® with adjuvant narrowband ultraviolet B (NB-UVB), are expected in December 2026. The European Medicines Agency (EMA) reviewed the protocol for the pivotal Phase III CUV107 study, which is anticipated to begin recruitment in November 2026. The company aims to submit robust data for marketing authorization, building on existing approvals for SCENESSE® in erythropoietic protoporphyria.
Key Highlights
- CUV105 vitiligo study topline results expected in December 2026.
- CUV105 evaluates SCENESSE® with NB-UVB vs. NB-UVB monotherapy.
- Primary endpoint: T-VASI50 (≥50% total body repigmentation).
- Secondary endpoint: F-VASI75 (≥75% facial repigmentation).
- EMA reviewed CUV107 protocol, advising on design for 300 patients.
- Pivotal Phase III CUV107 study to start November 2026.
- CUV107 study will have a 12-month recruitment period.
- SCENESSE® is currently approved for erythropoietic protoporphyria.
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