CLINUVEL says trial results show afamelanotide reduces DNA damage

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CLINUVEL says the results from a clinical trial in a genetic DNA repair disorder show that its afamelanotide – may be able to reduce the development of skin cancers.

The company said the trial results are the first showing the potential of afamelanotide to protect and treat patients with xeroderma pigmentosum (XP). XP is a rare disorder that causes extreme rates of skin cancers and forces patients to live in the dark.

“XP patients are known as ‘children of the moon’ due to their need to avoid any light and sun exposure or risk severe, aggressive skin cancers from an early age,” said CLINUVEL genomic scientist, Dr Jessica Nucci.

“Our first clinical trial results demonstrate that afamelanotide in adult XP patients can reduce key markers of light and ultraviolet DNA damage, suggesting we may be able to reduce the risk and frequency of skin cancers in these patients.”

XP affects a patient’s ability to repair DNA skin damage following exposure to light, particularly ultraviolet (UV) radiation. The disorder, which affects an estimated one in one million people, leads to a 1,000-fold increase in the risk of skin cancer and, tragically, a life expectancy of around 30 years.

CLINUVEL started clinical trials of afamelanotide in XP patients in 2020.

It said results from the first three XP patients treated showed a reduction in CPDs, particularly at deeper levels of the skin, and a decrease in sunburn under controlled laboratory conditions. Key markers such as p53 and γH2AX also showed response to the drug.

“These results are exciting as the findings may be translated to wider populations who are at higher risk of skin cancer due to DNA damage, such as those who are immunosuppressed or with fair skin, blue eyes and fair hair,” said Dr Nucci.

“In the immediate term, we have multiple studies of afamelanotide ongoing which may provide greater evidence of the potential of the drug to assist DNA regeneration in both XP patients and disease-free subjects.”