Clinuvel Pharmaceuticals expands pharmaceutical portfolio

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Clinuvel Pharmaceuticals (ASX:CUV) has expanded its pharmaceutical development portfolio with novel formulations of the melanocortin adrenocorticotropic hormone, Neuracthel.

The company said it has secured a supply of the melanocortin adrenocorticotropic hormone (ACTH) and will be evaluating the potential of Neuracthel for patients with neurological, endocrinological and degenerative disorders, who lack alternative therapy.

ACTH is from the same family of bioactive hormones – melanocortins – as afamelanotide. This is the first pharmaceutical product Clinuvel has successfully commercialised as Scenesse.

“ACTH is a well recognised, licensed treatment for a number of neurological and endocrinological diseases, yet global supply and availability of the product have recently been disrupted and its full clinical potential remains unrealised,” said Clinuvel's vice president of scientific affairs, Dr Tim Zhao.

“Our research and commercial expertise in melanocortin drugs and peptide drug delivery platforms means we are well placed to ensure the successful, safe and efficient development and commercialisation of ACTH formulations as Neuracthel. We also know there are many more underserved patient groups who would benefit from Neuracthel treatment, and we will be addressing these unmet medical needs. The company now has multiple products in development for patients and other populations,” said Dr Zhao.

Melanocortins are hormones that act on cells throughout the body and can play a role in regulating the central nervous system, energy balance, appetite, photoprotection and DNA repair. The naturally occurring human hormone ACTH is essential for the production of cortisol, enabling the combat of stress and regulation of immune responses, maintenance of blood pressure, moderation of blood sugar, and regulation of metabolism.

“Over the last two decades Clinuvel has established itself as the world experts in melanocortin drug development and commercialisation,” said the company's director of global operations, Lachlan Hay.

“Our understanding of the technology and potential of these products allow us to unlock value for patients who lack alternatives.”

"We can now methodically pursue our Neuracthel programs, having secured supply of ACTH to a current Good Manufacturing Practices, or cGMP, standard – the standard demanded by global regulatory authorities. Clinuvel’s formulation teams at the Vallaurix Research, Development and Innovation Centre in Singapore have advanced a number of innovative instant- and controlled-release formulations which are being used as platforms for melanocortin therapies, including ACTH,” added Dr Zhao.