Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Afamelanotide · 2 trials · 2 indications
Measured using Vitiligo Area Scoring Index (VASI). A decrease in VASI indicates a reduction of the body surface area affected by vitiligo (possible range 1-100).
Blood samples will be collected for analysis of afamelanotide plasma concentrations and understand what the maximum concentration in plasma is.
Blood samples will be collected for analysis of afamelanotide plasma concentrations.
| Arm | Type | Description |
|---|---|---|
| Afamelanotide and NB-UVB Light | EXPERIMENTAL | - |
| NB-UVB Light | OTHER | - |
| Afamelanotide 16 mg implant | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Afamelanotide and NB-UVB Light | DRUG | Patients will receive combination of NB-UVB twice weekly and afamelanotide every 3 weeks for 20 weeks. |
| NB-UVB Light | PROCEDURE | Patients will receive NB-UVB light twice per week for 20 weeks. Upon study completion, NB-UVB Light Arm participants will have the opportunity to enroll in an open-label extension phase of the study. In this extension phase, participants will undergo the same evaluations and assessments as the ones performed in the main part of the study under Afamelanotide and NB-UVB Light Arm. |
| Afamelanotide 16mg implant | DRUG | afamelanotide 16mg implant will be administered to each patient during the study. |
Inclusion Criteria: * Male and female patients with a confirmed diagnosis of generalized vitiligo with VASI≥3 of the body and VASI on the head and neck ≥0.3 including an F-VASI≥0.1 * Stable or active vitiligo * Aged 12 or more * Fitzpatrick skin types III-VI Exclusion Criteria: * Fitzpatrick skin...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Incyte Corporation | INCY | 5 | PHASE3 | povorcitinib, Ruxolitinib |
| Pfizer Inc. | PFE | 2 | PHASE3 | Ritlecitinib |
| AbbVie, Inc. | ABBV | 2 | PHASE3 | Upadacitinib |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 1 | PHASE2 | Zasocitinib |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE2 | GIA632 |
| Clinuvel, Inc. | CUVL | 1 | PHASE3 | Afamelanotide |
| Arcutis Biotherapeutics Inc | ARQT | 1 | PHASE2 | Roflumilast foam 0.3% |
| Forte Biosciences Inc. | FBRX | 1 | PHASE1 | FB102 |
| Eli Lilly and Company | LLY | 1 | PHASE2 | LY4005130 |
| Teva Pharmaceutical Industries Limited Sponsored ADR | TEVA | 1 | PHASE1 | TEV-53408 |
Afamelanotide is being studied for erythropoietic protoporphyria and vitiligo. In erythropoietic protoporphyria, it is evaluated in a Phase 1 pharmacokinetics study. In vitiligo, it is being tested in combination with narrow-band ultraviolet B light in a Phase 3 trial. It is an investigational therapy and has not been approved for these uses.
Afamelanotide is an agonist of the melanocortin 1 receptor, or MC1R. By activating MC1R, it mimics the action of alpha-melanocyte-stimulating hormone, which stimulates melanin production in skin cells. This mechanism underlies its investigation in conditions related to pigmentation and light sensitivity.
Afamelanotide is being developed by Clinuvel Pharmaceuticals Limited, which trades on the OTC market under the ticker CUVL as American Depositary Shares. The company is responsible for the clinical development of the drug in erythropoietic protoporphyria and vitiligo.
Afamelanotide is in Phase 1 and Phase 3 clinical development, depending on the indication. The Phase 1 trial in erythropoietic protoporphyria has been completed, while the Phase 3 trial in vitiligo is active but not recruiting. It remains an investigational drug and is not approved for these indications.
Afamelanotide has been studied in two clinical trials. NCT06388642 was a completed Phase 1 pharmacokinetic study in erythropoietic protoporphyria with 28 participants in Belgium and the Netherlands. NCT06109649 is an active Phase 3 trial in vitiligo comparing afamelanotide plus narrow-band ultraviolet B light versus light alone, with 200 participants across the United States, France, Kenya, and the United Kingdom.