“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
“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,”
Between five and six million cases of skin cancers are diagnosed in the
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,”
Final results from the CUV151 study and further results from CLINUVEL’s DNA Repair Program are expected later in 2023.
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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.
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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 (ASX: CUV;
CLINUVEL’s lead therapy, SCENESSE® (afamelanotide 16mg), is approved for commercial distribution in
SCENESSE®, PRÉNUMBRA®, NEURACTHEL®, and CYACÊLLE® are registered trademarks of CLINUVEL.
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