Key Highlights
- Focus on three clinical programs: vitiligo, adrenocorticotropic hormone (ACTH), and porphyrias (EPP and VP), selected for their highest potential for clinical and commercial success.
- Temporary suspension of programs in stroke, Parkinson’s disease, and xeroderma pigmentosum to optimise resource allocation.
- Continued development of PhotoCosmetic products, with launches of three product lines underway.
Strategic Realignment
CLINUVEL has redefined its priorities, focusing on clinical programs with the most promising outcomes and market opportunities. The decision, unanimously supported by the Board of Directors, aims to accelerate milestones and streamline operations by allocating resources toward:
- Vitiligo: Addressing unmet needs in extensive depigmentation with systemic treatments.
- Adrenocorticotropic Hormone (ACTH): Development of NEURACTHEL®, targeting conditions like infantile spasms, epilepsy, and multiple sclerosis.
- Porphyrias (EPP and VP): Expanding SCENESSE®’s use to improve patient quality of life.
This strategic consolidation will enhance efficiency, ensuring public markets can more easily track progress and value creation.
Melanocortin Development and Market Opportunities
CLINUVEL is a leader in developing and commercialising melanocortins—peptides critical to human physiology.
- SCENESSE® (afamelanotide): Established as the standard of care for erythropoietic protoporphyria (EPP) and progressing in late-stage trials for vitiligo and variegate porphyria (VP).
- NEURACTHEL®: A novel ACTH formulation targeting high-need neurological disorders.
- PhotoCosmetic Products: Introducing new consumer-focused lines to complement the pharmaceutical portfolio.
This strategic focus positions CLINUVEL as a “house of melanocortins,” addressing diverse and critical medical needs.
Board and Management Commentary
Dr. Jeffrey Rosenfeld, CLINUVEL’s Chair, emphasised that prioritisation allows the company to “accelerate development and generate meaningful milestone news for public investors.” The new direction reflects extensive deliberation and analysis of market and clinical trends.
Dr. Emilie Rodenburger, Director of Global Clinical Affairs, noted:
“This shift ensures our resources are focused on the programs with the highest probability of success, reinforcing our portfolio with SCENESSE®, PRÉNUMBRA®, and NEURACTHEL®.”
Next Steps and Outlook
CLINUVEL remains committed to photomedicine and broader initiatives supporting UV and light-sensitive communities while driving its pharmaceutical and consumer product developments forward.
The strategic realignment is expected to deliver:
- Accelerated progress in core programs.
- Streamlined operations for improved efficiency.
- Continued innovation and leadership in melanocortin-based therapies.
This focused approach ensures that CLINUVEL leverages its resources effectively to achieve regulatory and commercial milestones.
