NEURACTHEL(Clinuvel)

Study in healthy volunteers shows single dose of afamelanotide reduces erythema caused by ultraviolet radiationMELBOURNE, Australia, Feb. 02, 2023 (GLOBE NEWSWIRE) -- Results released today from a clinical study have shown that the drug afamelanotide can reduce critical skin damage caused by ultraviolet (UV) radiation, a leading factor in skin cancer and photoaging. The CUV151 study, conducted by Australian company CLINUVEL, treated nine fair-skinned volunteers with the photoprotective drug afamelanotide and showed that treatment could significantly reduce artificially provoked “sunburn damage” after just six days. “Frequent and intense sunburn is recognised as a primary risk factor for skin cancer, with fair skinned individuals – known as Fitzpatrick phototypes I-III – at high-risk,” CLINUVEL’s Head of Clinical Operations, Dr Pilar Bilbao said. “Showing that we can objectively reduce erythema, sunburn DNA damage, under controlled clinical conditions after a single dose of afamelanotide provides our team with valuable data on how this drug, and other similar molecules, can reduce the burden of UV-induced damage. Further clinical work is ongoing to assess the properties and influence of afamelanotide on other parts of cellular DNA,” Dr Bilbao said. Between five and six million cases of skin cancers are diagnosed in the USA alone every year, with UV exposure and fair skin proven to increase an individual’s lifetime risk.1 An estimated US$8.1 billion is spent annually treating skin cancers in the USA, suggesting more effective preventative measures are required. CLINUVEL is evaluating afamelanotide as a photoprotective and DNA repair treatment for individuals at highest-risk of UV and light damage, focusing first on patients with the DNA repair disorder xeroderma pigmentosum (XP). The CUV151 study followed a parallel protocol to clinical trials for XP patients, assessing biomarkers of UV-induced skin damage in healthy volunteers following provocation of UV damage before and after afamelanotide treatment. The first results showed a statistically significant decrease in UV-erythema dose response, the redness indicative of first DNA damage, which was provoked by incremental doses of UV light (p=0.018). An increase in the minimal erythemal dose – a measure of intensity of UV light to provoke sunburn – was also found. Earlier results in XP patients showed that afamelanotide could reduce UV-induced DNA damage, with analyses of skin samples (biopsies) from CUV151 ongoing to assess DNA damage in the healthy volunteers. “Today’s results build upon the decades of research CLINUVEL has conducted into the use of afamelanotide to protect skin from light, with the first evidence that a single dose of the drug has a photoprotective effect in healthy volunteers. These data add to our regulatory dossier for XP while further developing our specialised healthcare products for wider populations at highest risk of UV-induced damage and skin cancer,” Dr Bilbao said. Final results from the CUV151 study and further results from CLINUVEL’s DNA Repair Program are expected later in 2023. Media enquiries: Monsoon Communications, Mr Rudi Michelson, +61 411 402 737, rudim@monsoon.com.au Note to media: CLINUVEL has released further investor and technical releases on results from the CUV151 study. For more details, go to www.clinuvel.com. 1 Skin & Cancer Foundation – Skin Cancer Facts & Statistics, https://www.skincancer.org/skin-cancer-information/skin-cancer-facts/; American Academy of Dermatology – Skin Cancer https://www.aad.org/media/stats-skin-cancer. About Afamelanotide Afamelanotide belongs to the family of melanocortins, hormones and their analogues, which are recognised to activate human pigmentation, reduce oxidative damage, inflammation and swelling, and optimise the response of skin cells to UV-induced damage. CLINUVEL is already marketing a controlled-release formulation of afamelanotide – known as SCENESSE® – as the world’s first photoprotective drug for the rare disorder erythropoietic protoporphyria (EPP). Further results from the Company’s DNA repair program are expected later in 2023. About CLINUVEL PHARMACEUTICALS LIMITED CLINUVEL (ASX: CUV; ADR LEVEL 1: CLVLY; BÖRSE FRANKFURT-DAX: UR9) is a global specialty pharmaceutical group focused on developing and commercialising treatments for patients with genetic, metabolic, systemic, and life-threatening, acute disorders, as well as healthcare solutions for specialised populations. As pioneers in photomedicine and the family of melanocortin peptides, CLINUVEL’s research and development has led to innovative treatments for patient populations with a clinical need for systemic photoprotection, assisted DNA repair, repigmentation and acute or life-threatening conditions who lack alternatives. CLINUVEL’s lead therapy, SCENESSE® (afamelanotide 16mg), is approved for commercial distribution in Europe, the USA, Israel and Australia as the world’s first systemic photoprotective drug for the prevention of phototoxicity (anaphylactoid reactions and burns) in adult patients with erythropoietic protoporphyria (EPP). Headquartered in Melbourne, Australia, CLINUVEL has operations in Europe, Singapore, and the USA. For more information, please go to https://www.clinuvel.com. SCENESSE®, PRÉNUMBRA®, NEURACTHEL®, and CYACÊLLE® are registered trademarks of CLINUVEL. Head of Investor Relations Mr Malcolm Bull, CLINUVEL PHARMACEUTICALS LTD Investor Enquiries https://www.clinuvel.com/investors/contact-us Forward-Looking Statements This release contains forward-looking statements, which reflect the current beliefs and expectations of CLINUVEL’s management. Please see the full disclaimer on CLINUVEL’s website. www.clinuvel.com Level 11535 Bourke StreetMelbourne - Victoria, Australia, 3000 T +61 3 9660 4900 F +61 3 9660 4909

Melanocortin drug NEURACTHEL® (ACTH) added for neurological, endocrinological and degenerative disorders MELBOURNE, Australia, Nov. 08, 2021 (GLOBE NEWSWIRE) -- CLINUVEL has expanded its pharmaceutical development portfolio with NEURACTHEL®, novel formulations of the melanocortin adrenocorticotropic hormone (ACTH). The Company has secured supply of ACTH with one of its strategic partners to meet existing global demand, 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, the first pharmaceutical product CLINUVEL has successfully commercialised as SCENESSE®.1 Various formulations of ACTH are approved globally for patient use, with 2020 sales of the drug estimated at US$1.29 billion and expected to grow to around US$1.91 billion by 2031.2 “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,” CLINUVEL’s VP of Scientific Affairs, Dr Tim Zhao said. “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,” Dr Zhao said. Melanocortins are hormones which act on cells throughout the body and can play a role in regulating the central nervous system, energy balance, appetite, photoprotection and DNA repair, as well sexual function. 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,” CLINUVEL’s Director of Global Operations, Mr Lachlan Hay said. “Our understanding of the technology and potential of these products allow us to unlock value for patients who lack alternatives.” CLINUVEL’s teams have proven expertise in melanocortin development with an initial focus on SCENESSE®, the world’s first systemic photoprotective drug, formulated as a controlled-release injectable implant in light and UV-provoked diseases. The Company is currently evaluating the potential of afamelanotide and other melanocortin drugs as therapeutic agents for patients with acute and life-threatening genetic, metabolic, neurological, vascular, endocrinological, and degenerative disorders. “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,” Dr Zhao said. 1 SCENESSE® is approved in Europe, the USA and Australia for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP). 2 Adrenocorticotropic hormone (ACTH) market – global industry analysis, size, share, trends, and forecast, 2017-2031 by Transparency Market Research (TMR), 2021. Media Enquiries Monsoon Communications Mr Rudi Michelson, 61 411 402 737, rudim@monsoon.com.au About CLINUVEL PHARMACEUTICALS LIMITED CLINUVEL PHARMACEUTICALS LTD (ASX: CUV; NASDAQ INTERNATIONAL DESIGNATION ADR: CLVLY; XETRA-DAX: UR9) is a global and diversified biopharmaceutical company focused on developing and commercialising treatments for patients with genetic, metabolic, systemic, and life-threatening, acute disorders, as well as healthcare solutions for the general population. As pioneers in photomedicine and understanding the interaction of light and human biology, CLINUVEL’s research and development has led to innovative treatments for patient populations with a clinical need for systemic photoprotection, DNA repair and acute or life-threatening conditions. These patient groups range in size from 5,000 to 45 million worldwide. CLINUVEL’s lead compound, SCENESSE® (afamelanotide 16mg), was approved by the European Commission in 2014, the US Food and Drug Administration in 2019 and the Australian Therapeutic Goods Administration in 2020 as the world’s first systemic photoprotective dug for the prevention of phototoxicity (anaphylactoid reactions and burns) in adult patients with erythropoietic protoporphyria (EPP). More information on EPP can be found at . Headquartered in Melbourne, Australia, CLINUVEL has operations in Europe, Singapore and the USA. For more information, please go to . SCENESSE® , PRÉNUMBRA® , and NEURACTHEL® are registered trademarks of CLINUVEL PHARMACEUTICALS LTD. Head of Investor Relations Mr Malcolm Bull, CLINUVEL PHARMACEUTICALS LTD Investor Enquiries Forward-Looking Statements This release contains forward-looking statements. Please see for further details Level 11, 535 Bourke Street, Melbourne - Victoria, Australia, 3000 T +61 3 9660 4900 F +61 3 9660 4909