2021 Announcements Clinical Corporate News

Media Release – CLINUVEL Expands DNA Repair Program

SCENESSE® (afamelanotide 16mg) to be evaluated in xeroderma pigmentosum variant (XP-V)

CLINUVEL has expanded its clinical program to evaluate the DNA reparative potential of afamelanotide in skin cells which have been damaged by ultraviolet (UV) and sun exposure. The program now includes patients with the rare disorders XP-V and XP-C. Having reached agreement with clinical and academic experts, CLINUVEL will generate clinical data on the safety and efficacy of SCENESSE® (afamelanotide 16mg).

“XP patients are at extreme risk of skin cancer – up to 10,000 times that of the general population – due to their inability to repair damage caused by UV and sunlight, known as photodamage,” CLINUVEL’s Chief Scientific Officer, Dr Dennis Wright said. “Afamelanotide has been shown to protect skin from UV and light, and repair photodamage. We are now working to confirm this concept in clinical trials with both XP patients and healthy volunteers.”

UV radiation penetrates into the nucleus of skin cells and causes defects of the DNA helix known as photoproducts. If left unrepaired, these chemical changes to DNA may replicate as mutations, leading to irreversible damage (photoaging) and may further progress to skin cancer, including melanoma. Human biology contains complex mechanisms to protect itself from UV damage and restore cellular DNA to its original state. Due to genetic defects, XP patients have impaired DNA repair processes, leading to an extreme risk of skin cancer from an early age and a life expectancy of around 30 years. Afamelanotide, the active ingredient in SCENESsE•, improves the function of skin cells which have incurred photodamage and assists these cells to repair DNA through several mechanisms, including nucleotide excision repair (NER). CLINUVEL is conducting clinical trials in XP-C and XP-V patients, as well as healthy volunteers, to evaluate the safety and efficacy of afamelanotide as a DNA regenerative therapy.

“Up to two billion individuals of fair-skinned complexion are known to have defects in UV protective and DNA repair processes, including NER, increasing their long-term risk of skin cancer,” Dr Wright said. “XP patients are at the most extreme risk and serve as a model for what happens if UV-induced damage is left unrepaired.

“I am pleased that we have been able to reach agreement with global XP experts to expand the ONA Repair Program and evaluate SCENESSE®  in XP-V patients and look forward to first results – pending the COVIO- 19 pandemic – in 2021,” Dr Wright said.

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