Clinuvel’s Vitiligo Therapy Maintains Pigment 6 Months After Treatment Ends
Clinuvel showcases vitiligo and EPP progress at North America’s largest dermatology conference
Clinuvel Pharmaceuticals presented vitiligo results and erythropoietic protoporphyria (EPP) data across multiple sessions at the 2026 American Academy of Dermatology (AAD) Annual Meeting in Denver. The company’s afamelanotide therapy featured in presentations delivered to an estimated 20,000 attendees, including dermatologists, researchers, students, patients and industry professionals. Clinuvel (ASX: CUV) operated a bespoke “Pavilion of Photomedicine” exhibition space amongst 350 exhibiting peers, signalling strategic intent to build U.S. market presence ahead of a planned Nasdaq listing.
The company supported three expert satellite symposia during the event, including the Photodermatology Society 35th Annual Meeting, the Global Vitiligo Foundation Annual Symposium, and the Skin of Color Society Scientific Symposium. The three-day Pavilion showcased Clinuvel’s vitiligo programme, the planned CUV107 study, and the newly revealed Vitiligo Visual Algorithm (VVA).
Lachlan Hay, Chief Operating Officer
“CLINUVEL’s presence at AAD 2026 – among 20,000 healthcare professionals – fits perfectly well as we advance the vitiligo program. It is therefore essential that U.S. dermatologists not only recognise CLINUVEL for its focus on pigmentary disorders and photomedicine but actually see the effects of the drug developed in vitiligo. Additionally, it is logical that we have a large presence year-on-year to achieve name recognition as we prepare for entry to the Nasdaq stock exchange.”
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What the CUV105 vitiligo case studies reveal
Prof A. Bertolotti presented patient case studies from the ongoing CUV105 study at the AAD meeting. The cases demonstrated repigmentation following 20 weeks of therapy with afamelanotide combined with narrowband ultraviolet B (NB-UVB) phototherapy. The data showed maintenance of pigmentation in patients with darker skin types (Fitzpatrick IV-VI) after withdrawal of therapy for up to six months.
Commentary during the Q&A session noted that many of the patients presented had active disease and still responded to treatment, a characteristic described as not commonly seen with other therapies. Prof J. Seneschal and Dr B. Ehst discussed the use of afamelanotide as future treatment in separate vitiligo sessions. Afamelanotide is not currently approved for vitiligo.
The three key takeaways from CUV105 case studies are:
- Repigmentation occurred after 20 weeks of afamelanotide therapy combined with NB-UVB phototherapy
- Pigmentation maintenance persisted for up to six months after treatment withdrawal in darker skin types (Fitzpatrick IV-VI)
- Patients with active disease responded to treatment, an observation noted as uncommon with competing therapies
How afamelanotide compares to JAK inhibitors for vitiligo
A longer-term follow-up study with topical ruxolitinib, presented by Dr G. Wong, demonstrated that patients who respond to therapy but withdraw from treatment after 52 weeks experience high rates of relapse. Dr A. Alexis highlighted that prolonged treatment with ruxolitinib (52 weeks or more) can result in satisfactory results, even if patients do not respond after 26 weeks. Commentary from multiple presenters suggested that long-term maintenance therapy was required with topical ruxolitinib.
Results from two Phase III studies of the oral JAK-1 inhibitor upadacitinib, presented by Prof T. Passeron, showed that 19.4% and 21.5% of patients in the two studies experienced a T-VASI change ≥50% on active drug compared to 5.9% for placebo. Similar changes in F-VASI75 were reported. Safety data were consistent with previously reported oral JAK inhibitor profiles.
Presenters noted that JAK inhibitors require frequent and long-term dosing before repigmentary effects in vitiligo can be expected, often requiring more than one year of treatment. This positions afamelanotide’s emerging profile as potentially differentiated, particularly regarding treatment duration and maintenance of response after withdrawal.
| Therapy | Mechanism | Treatment Duration | Relapse Risk | Approval Status |
|---|---|---|---|---|
| Afamelanotide (CUV105) | Melanocortin-based melanocyte stimulation | 20 weeks (study data) | Pigmentation maintained up to 6 months post-withdrawal | Not approved for vitiligo |
| Ruxolitinib (topical) | JAK inhibitor (immune modulation) | 52+ weeks for satisfactory results | High relapse rates after 52-week withdrawal | Approved (market dependent) |
| Upadacitinib (oral) | JAK-1 inhibitor (immune modulation) | Often >1 year before visible effect | Ongoing dosing required | Phase III trials completed |
Understanding vitiligo treatment approaches
Vitiligo is a skin condition characterised by loss of pigment due to the destruction or dysfunction of melanocytes (the cells responsible for producing skin colour). Treatment approaches aim to stimulate repigmentation by either activating remaining melanocytes or modulating the immune response that attacks these cells.
Melanocortin-based therapies like afamelanotide work by directly stimulating melanocyte activity and pigment production. JAK inhibitors operate through immune modulation, targeting the inflammatory pathways that contribute to melanocyte destruction. The Vitiligo Area Scoring Index (VASI) is a tool developed to evaluate the extent of depigmentation in clinical settings, applicable to total body surface area (T-VASI) or specific regions such as the face (F-VASI). The traditional VASI has a reported error rate of 50%, contextualising Clinuvel’s development of AI-driven alternatives.
Key differences between treatment mechanisms:
- Melanocortin-based (afamelanotide): Directly stimulates melanocyte activity and pigment production
- JAK inhibitors (ruxolitinib, upadacitinib): Modulate immune response to reduce melanocyte destruction
- Treatment duration: Afamelanotide study data shows results at 20 weeks; JAK inhibitors typically require 52+ weeks
- Post-treatment maintenance: Afamelanotide data suggests maintained pigmentation up to 6 months after withdrawal; JAK inhibitors show high relapse rates upon cessation
AI-driven tools and the psychodermatology opportunity
Clinuvel revealed its first AI-driven Vitiligo Visual Algorithm (VVA) to assist in the interpretation of vitiligo photography. The tool will be refined with the assistance of physicians, patients and researchers. Prof Passeron presented related work focused on quantifying depigmentation of the face in vitiligo patients using an AI tool, noting the current error rate of the traditional VASI is 50%.
The field of psychodermatology emerged as a focus area at AAD 2026. Data presented by Dr I. Hamzavi reported nearly 48% of U.S. vitiligo patients have one or more mental health comorbidity. This positions mental health impact as a material consideration in vitiligo treatment development and patient care approaches.
The VVA represents Clinuvel’s entry into AI-driven diagnostics for vitiligo, an area where the existing VASI scoring system demonstrates significant measurement limitations. The connection between dermatological conditions and mental health outcomes may create optionality for integrated treatment approaches addressing both physical and psychological dimensions of vitiligo.
Dr Emilie Rodenburger, Director, Global Clinical Affairs
“The key takeaway this year is that systemic and oral JAK inhibitors take a long time to produce a positive visible effect and withdrawal of the JAK inhibitor results in relapse in vitiligo.”
EPP safety profile reinforced, competitor data raises questions
Dr R. Gadow presented long-term effects of afamelanotide on epidermal pigmentation in EPP patients, focusing on solar spots (lentigines and naevi). Analyses of 5 years of treatment in 104 patients confirmed that afamelanotide had no reported effect on malignant transformation or naevi. No drug-related malignancies have been reported after more than 21,000 doses administered.
Clinuvel’s SCENESSE (afamelanotide 16mg) is the only FDA- and EMA-approved treatment for EPP. Prof S. Ibbotson noted that afamelanotide has been rather an outstanding change for Scottish EPP patients.
Top-line results from a Phase III study of dersimelagon, an oral formulation being evaluated in EPP, were presented by Dr A. Yeung. While adverse events were shown, Dr Yeung discussed one serious adverse event in a patient receiving active drug which was omitted from the tabulations presented to the audience and led to the patient withdrawing from the study.
Key EPP safety data points:
- 5 years of treatment data across 104 patients with no reported malignant transformation or effects on naevi
- 21,000+ doses administered with no drug-related malignancies reported
- SCENESSE remains the only FDA- and EMA-approved EPP treatment, creating a high regulatory barrier to entry for competitors
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Strategic outlook and next steps
Clinuvel’s stated strategic priorities centre on advancing the CUV107 study, refining the VVA with input from physicians and researchers, and preparing for Nasdaq listing. The Pavilion of Photomedicine serves as a vehicle for brand-building and physician engagement within the U.S. dermatology community, positioning the company for expanded market presence.
The AAD 2026 presentations position afamelanotide’s vitiligo profile as potentially differentiated from JAK inhibitor therapies regarding treatment duration and maintenance of response after withdrawal. The EPP safety dataset reinforces the established regulatory and commercial foundation for SCENESSE.
Upcoming milestones include:
- Progression of the CUV107 vitiligo study
- Refinement of the Vitiligo Visual Algorithm (VVA) with physician, patient and researcher input
- Continued preparation for Nasdaq stock exchange listing
- Ongoing development of the Pavilion of Photomedicine as a U.S. market engagement platform
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