| Melbourne, Australia, 30 March 2022 | ASX: XETRA-DAX: Level 1 ADR: |
CUV UR9 CLVLY |
Executive Summary:
- Expansion of DNA Repair Program to second group of xeroderma pigmentosum patients: XP-V
- Afamelanotide evaluated as photoprotective and DNA repair therapy
- First XP-V patient dosed
CLINUVEL today announced that the first xeroderma pigmentosum variant (XP-V) patient has received afamelanotide treatment in the third active study in the Company’s DNA Repair Program (CUV152). The CUV152 study seeks to confirm the ability of afamelanotide to protect DNA following ultraviolet- (UV) and light-induced damage.
Up to six adult patients with either the XP-C complementation group or XP-V– treated at European XP expert centres – will receive up to six doses of afamelanotide during the pilot CUV152 study.
“Deficient DNA repair mechanisms place over two billion individuals globally at increased risk of skin cancer, and XP patients are at extreme risk of solar damage and skin cancer due to their genetic defects,” CLINUVEL’s Head of Clinical Operations, Dr Pilar Bilbao said. “Our innovative DNA Repair Program is evaluating whether afamelanotide can be safely administered to these patients to both reduce and repair DNA damage, with the ultimate goal of prolonging and improving their lives.”
First systemic photoprotective treatment evaluated for XP patients
XP is a rare life-threatening inherited disorder characterised by defects in the body’s own system to repair damage due to UV light. XP-V patients’ genetic defect (POLH gene) means that as patients’ DNA is damaged following exposure to UV and light (HEV), their cells replicate with an increased number of errors, leading to an increase in mutations and overall high rate of skin cancer.
“CLINUVEL’s drug afamelanotide is the first ever systemic therapy to be evaluated in XP patients, with clinical trials CUV152 and CUV156 now focused on XP-V and XP-C, respectively,” Dr Bilbao said. “In parallel the mechanistic CUV151 study – in disease-free subjects – is providing further insights into afamelanotide’s ability to safely protect skin from light and restore DNA, which has incurred damage from light exposure.
“Depending on the centres’ ability to process the patients within the agreed timeframe, we expect to have first results from all three of these studies later in 2022. The results will help us to progress the next steps in the DNA repair program and allow discussion of late-stage development of an already marketed product with global regulatory bodies.”
Melanocortins and DNA Repair
Afamelanotide belongs to a family of bioactive peptides and their analogues – known as melanocortins – which can reduce photoproducts (pyrimidine dimers and other damage markers) caused by UV radiation and visible light. Afamelanotide protects skin from UV damage through the induction of eumelanin, the dark pigment, in skin. Eumelanin also provides antioxidative defence and has a neutralising effect on skin damage. Further research has shown the ability of melanocortins such as alpha-melanocyte stimulating hormone to assist skin cells in DNA repair mechanisms (NER and BER).¹
Having successfully commercialised afamelanotide as SCENESSE®, the world’s first photoprotective drug, CLINUVEL is developing a range of melanocortin products for use in patient populations and broader audiences.
¹ Nucleotide excision repair (NER) and Base Excision Repair (BER) are processes by which cells repair DNA damage. For further details, please see CLINUVEL’s DNA Repair Communique series.
