| Melbourne, Australia, 17 March 2022 | ASX: XETRA-DAX: Level 1 ADR: |
CUV UR9 CLVLY |
Executive Summary
- NEURACTHEL® (ACTH) – part of CLINUVEL’s expanded melanocortin portfolio
- Drug substance being manufactured under current Good Manufacturing Practices
- Development and validation work in progress
- CLINUVEL translates its expertise in melanocortins and formulations
CLINUVEL is progressing scaled manufacturing of adrenocorticotropic hormone (ACTH) under current Good Manufacturing Practice (cGMP), as it strives to finalise the development and validation work necessary for a complete regulatory dossier. As part of a differentiated business strategy to develop and commercialise a broad suite of melanocortins, the Company has engaged a commercial manufacturing partner and strengthened its intellectual property portfolio.
Melanocortin Family
ACTH is a human hormone, derived from the precursor peptide proopiomelanocortin (POMC), and synthesised by the pituitary gland. ACTH regulates a variety of processes, such as energy homeostasis and metabolism, cortisol production, and nerve regeneration. An injectable gel formulation of ACTH is approved by the US Food and Drug Administration (FDA) for the treatment of 19 different medical conditions, including infantile spasms, acute exacerbations of multiple sclerosis, and rheumatic disorders.
CLINUVEL has identified broader clinical potential for ACTH, a hormone to treat neurological, endocrinological, and degenerative disorders, and announced in November 2021 that it was adding ACTH to its existing melanocortin portfolio.
Global Opportunity for NEURACTHEL®
CLINUVEL will launch its ACTH product range under the trade names NEURACTHEL® Instant and NEURACTHEL® Modified-release for patients with neurological, endocrinological, and degenerative disorders.
Worldwide, the ACTH market has been growing annually since 2014, with a projected CAGR of 3.9% from 2021 to 2031. The global use of ACTH was valued at US$1.29 billion in 2020, and projected to reach US$1.91 billion by 2031.¹ The driving factors for the expansion of the global ACTH market include the rise in the number of diseases and patients to be diagnosed and treated by the bioactive hormone.
Commentary
“We are differentiating CLINUVEL from any other pharmaceutical group by manufacturing and developing the further use of NEURACTHEL®,” CLINUVEL’s Vice President of Scientific Affairs, Dr Tim Zhao said. “Not only are we focusing our knowledge on this family of bioactive peptides, but also widening the scope of use for ACTH, a potent hormone.
”We have a clear vision of what we are building towards and how to reach many patients in need. The huge advantage of our program is already the cumulative clinical exposure and experiences of this hormone in different regions and patient groups, such that there is available indicative safety and efficacy information from which we can build and derive novelty,” Dr Zhao said.
