CLINICAL TRIALS PROFILE FOR AFAMELANOTIDE

All Clinical Trials for Afamelanotide

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00472901 ↗	Phase III Trial of CUV1647 in Polymorphic Light Eruption (PLE)	Completed	Clinuvel Pharmaceuticals Limited		2007-05-01	The purpose of this study is to determine whether the afamelanotide (CUV1647) formulation is effective in preventing PLE episodes or reducing the severity of PLE symptoms in patients with a well documented history of the disease. The study also aims to determine whether treatment with afamelanotide (CUV1647) can reduce the use of rescue medication in this group.
NCT00829192 ↗	Phase II AK Study in Organ Transplant Patients	Unknown status	Clinuvel Pharmaceuticals Limited	Phase 2	2007-11-01	The purpose of this study is to determine whether afamelanotide (CUV1647) is effective in reducing the number of actinic keratoses and squamous cell carcinomas developing in immune compromised organ transplant recipients, who are at particularly high risk, over a 24 month test period. The number of lesions formed on the head, hands and forarms will be monitored over this 24 month test period.
NCT00859534 ↗	Phase II Solar Urticaria (SU) Pilot Study	Completed	Clinuvel Pharmaceuticals Limited	Phase 2	2008-12-01	Urticaria is one of the most common dermatological conditions with diverse clinical presentations and causes. Solar urticaria (SU) is a rare subset of physical urticaria, where symptoms are induced by direct exposure of the skin to sunlight. As little as 5 minutes of sun exposure can cause flares and whealing on exposed skin sites, accompanied by severe itching. The wavelengths of radiation causing the eruption (i.e. the action spectrum) are in the ultraviolet or visible light range. Initially described by Merklen in 1904, SU may have a very sudden and dramatic onset, and then rapidly disappear once the exposure ceases. A delayed form of SU has also been reported, although this is extremely rare. Information on the pathophysiology of SU is limited and symptoms are confined to areas of the body exposed to direct sunlight. The condition can be very distressing and severely impair the individual's ability to go outdoors and to tolerate indoor lighting. The standard therapy, i.e. oral antihistamines, is only partially effective and may provide little worthwhile relief of symptoms. This pilot study is proposed to evaluate implants containing 16mg CUV1647 as a prophylactic treatment for patients with SU. The effectiveness of CUV1647 will be assessed by determining the minimum urticarial dose before and after treatment.
NCT00979745 ↗	Phase III Confirmatory Study in Erythropoietic Protoporphyria (EPP)	Completed	Clinuvel Pharmaceuticals Limited	Phase 3	2009-09-01	Afamelanotide is a man-made drug being studied for use as a preventative medication for EPP sufferers. It is a synthetically produced analogue of human alpha melanocyte stimulating hormone (alpha-MSH) and is not yet available on the market. The purpose of this study is to look at whether afamelanotide can reduce the number and severity of EPP symptoms when patients are exposed to light. This study will also look at how the drug is tolerated when taken by people with EPP. The study will involve the use of an implant, which comes in the form of a small rod (approximately 2 cm x 0.15 cm) to be administered under the skin. The implant may contain the study drug afamelanotide or a placebo (inactive medication). Over 450 subjects have been treated with afamelanotide to date with no serious safety concerns identified. For this study, afamelanotide has been formulated as a controlled release depot injection (implant). This means that the afamelanotide will be released slowly into the body over a few days. Once inserted, the implant will remain in the body after afamelanotide has been released and will slowly dissolve. This study will help to provide more information about afamelanotide. This information will be used to determine the safety and efficacy (the ability of the drug to produce an effect) of this drug in EPP sufferers. Up to 70 people will participate in this study from study sites across Europe.

Clinical Trial Conditions for Afamelanotide

Condition Name

Condition Name for Afamelanotide
Intervention	Trials
Vitiligo	5
Erythropoietic Protoporphyria	5
Xeroderma Pigmentosum	2
Healthy	1

Condition MeSH

Condition MeSH for Afamelanotide
Intervention	Trials
Vitiligo	5
Protoporphyria, Erythropoietic	5
Xeroderma Pigmentosum	2
Exanthema	2

Clinical Trial Locations for Afamelanotide

Trials by Country

Trials by Country for Afamelanotide
Location	Trials
United States	17
Australia	5
United Kingdom	5
Germany	3
Netherlands	2

Trials by US State

Trials by US State for Afamelanotide
Location	Trials
New York	3
California	3
Michigan	2
Utah	2
Texas	2

Clinical Trial Progress for Afamelanotide

Clinical Trial Phase

Clinical Trial Phase for Afamelanotide
Clinical Trial Phase	Trials
Phase 3	6
Phase 2	12
Phase 1	3

Clinical Trial Status

Clinical Trial Status for Afamelanotide
Clinical Trial Phase	Trials
Completed	14
Recruiting	6
Unknown status	1

Clinical Trial Sponsors for Afamelanotide

Sponsor Name

Sponsor Name for Afamelanotide
Sponsor	Trials
Clinuvel Pharmaceuticals Limited	16
Clinuvel Europe Limited	2
Clinuvel, Inc.	2

Sponsor Type

Sponsor Type for Afamelanotide
Sponsor	Trials
Industry	22

Afamelanotide: Clinical Trials, Market Analysis, and Projections

Introduction to Afamelanotide

Afamelanotide, marketed as SCENESSE, is a synthetic analog of alpha-melanocyte-stimulating hormone (α-MSH) that functions as a melanocortin-1 receptor (MC1R) agonist. This drug has been approved for use in erythropoietic protoporphyria (EPP) in the United States since 2019 and is now being explored for its potential in treating vitiligo.

Clinical Trials Update

CUV 105 Phase 3 Clinical Trial

One of the most significant ongoing clinical trials involving afamelanotide is the CUV 105 trial. This phase 3, multicentric, randomized, controlled study aims to evaluate the efficacy and safety of afamelanotide in combination with narrowband ultraviolet B (NB-UVB) phototherapy for treating vitiligo[1][4].

• Study Design: The trial is designed to compare the combination therapy of afamelanotide and NB-UVB phototherapy against NB-UVB monotherapy. It targets patients with Fitzpatrick skin types IV to VI, as previous research has shown more significant repigmentation in these skin types.
• Dosage and Observation: The trial features an increased dosage of afamelanotide, with 16 mg administered compared to previous trials. An additional 6-month follow-up period post-treatment is included to assess the durability of repigmentation and monitor for any potential relapse or adverse effects.
• Inclusion and Exclusion Criteria: Patients must have extensive vitiligo affecting both the face and body. Exclusion criteria include recent phototherapy, history of skin cancer, and severe liver disease.
• Adverse Effects: Common adverse effects reported include erythema, diffuse hyperpigmentation (a universal effect due to melanocyte stimulation), nausea, and pruritus[1].

Market Analysis

Global Market Size and Forecast

The global market for afamelanotide is anticipated to grow significantly over the next few years. Here are some key market projections:

• Current Market Size: The global afamelanotide market was valued at several million USD in 2023[2][3].
• Forecasted Growth: The market is expected to reach a significantly higher value by 2030, with a compound annual growth rate (CAGR) during the forecast period of 2024-2030[2][3].
• Regional Markets: The North American, European, and Asia-Pacific markets are expected to contribute substantially to this growth. For instance, the North American market is projected to increase from its 2023 value to a higher value by 2030, while the Asia-Pacific market is also expected to see significant growth during the same period[2][3].

Key Players

The global afamelanotide market is dominated by several key players:

• Clinuvel Pharmaceuticals: As the primary developer of afamelanotide, Clinuvel Pharmaceuticals plays a crucial role in the market.
• Aspen API, Jin Dun Medical, and Winhealth Pharma: These companies are also significant players in the global afamelanotide market[2][3].

Market Segmentation

By Region

The market is segmented by region, including North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. Each region has its own growth trajectory and market size projections[2][3].

By Type and Application

The market is also segmented by type (e.g., SFM implantation cannula and other implantation devices) and application. Understanding these segments helps in developing targeted business strategies and assessing the competitive situation[2][3].

Vitiligo Market Impact

The initiation of the CUV 105 trial and the potential approval of afamelanotide for vitiligo treatment are expected to significantly impact the vitiligo market.

• Vitiligo Market Size: The vitiligo market is projected to reach USD 439.1 million by 2034, up from USD 307.1 million in 2023. Innovations in phototherapy and systemic treatments like afamelanotide are driving this growth[4].

Safety and Efficacy Data

Previous Clinical Trials

Afamelanotide's safety and efficacy have been evaluated in several clinical trials, particularly for EPP:

• Clinical Trials for EPP: Three randomized, multicenter, prospective, vehicle-controlled clinical trials (Study CUV029, Study CUV030, and Study CUV039) involving 244 adult subjects with EPP have demonstrated the safety and efficacy of afamelanotide. Subjects received subcutaneous SCENESSE implants containing 16mg of afamelanotide every 2 months[5].

Challenges and Future Directions

Patient Recruitment

Identifying patients with the requisite severity of vitiligo and meeting the strict inclusion and exclusion criteria poses a significant challenge for the CUV 105 trial[1].

Market Competition

The global afamelanotide market is competitive, with several key players. Companies need to develop robust business strategies to maintain their market share and position themselves for future growth[2][3].

Key Takeaways

• Clinical Trials: The CUV 105 trial is a significant step towards evaluating afamelanotide's efficacy and safety in treating vitiligo.
• Market Growth: The global afamelanotide market is expected to grow substantially by 2030, driven by increasing demand and new applications.
• Safety and Efficacy: Afamelanotide has a robust safety profile and has shown efficacy in promoting skin repigmentation.
• Market Segmentation: Understanding regional and application-based market segments is crucial for developing effective business strategies.
• Vitiligo Market Impact: The potential approval of afamelanotide for vitiligo treatment is expected to significantly impact the vitiligo market.

FAQs

What is afamelanotide and how does it work?

Afamelanotide is a synthetic analog of alpha-melanocyte-stimulating hormone (α-MSH) that functions as a melanocortin-1 receptor (MC1R) agonist, promoting the production of eumelanin, the pigment responsible for skin coloration.

What is the current status of the CUV 105 clinical trial?

The CUV 105 trial is an ongoing phase 3 clinical trial evaluating the efficacy and safety of afamelanotide in combination with NB-UVB phototherapy for treating vitiligo. It is actively recruiting participants at multiple sites across the US.

What are the common adverse effects of afamelanotide?

Common adverse effects include erythema, diffuse hyperpigmentation, nausea, and pruritus.

Who are the key players in the global afamelanotide market?

The key players include Clinuvel Pharmaceuticals, Aspen API, Jin Dun Medical, and Winhealth Pharma.

How is the global afamelanotide market expected to grow by 2030?

The global afamelanotide market is expected to grow significantly by 2030, with a projected increase in value and a notable CAGR during the forecast period of 2024-2030.

Sources

1. Exploring Afamelanotide for Vitiligo: Insights into the CUV 105 Phase 3 Clinical Trial. Dermatology Times.
2. Afamelanotide - Global Market Share and Ranking, Overall Sales and Demand Forecast 2024-2030. QYResearch.
3. Global Afamelanotide Market Research Report 2024. QYResearch.
4. Vitiligo Market Size to Reach USD 439.1 Million by 2034, Impelled by Innovations in Phototherapy. BioSpace.
5. Safety and Efficacy Data - SCENESSE® (Afamelanotide). Scenesse.com.