SCENESSE® DNA REPAIR STUDY IN HEALTHY VOLUNTEERS APPROVED

Melbourne, Australia, 30 November 2020

CLINUVEL PHARMACEUTICALS LTD today announced that it has obtained approval to commence a new study assessing the effect of its drug SCENESSE® (afamelanotide 16mg) on DNA repair capacity in healthy volunteers, part of the Company’s DNA Repair Development Program.1 SCENESSE® is understood to protect and repair DNA, a concept that is now being confirmed in the clinic.

DNA Damage and Repair

Ultraviolet (UV) and high energy visible (HEV) light2 penetrate human skin, leading to cellular oxidative stress and damage to DNA within the nucleus of skin cells. This damage consists of changes to the DNA structure which, if left unrepaired, can replicate and increase the risk of skin cancers, such as melanoma.

Under normal conditions, human biology is capable of repairing DNA damage through nucleotide excision repair and/or base excision repair (NER and BER, respectively), in which defective strands of DNA are “snipped” and removed, and replaced by the correct DNA sequences. Deficiencies in these repair processes – commonly seen in fair-skinned individuals of Anglo-Saxon origin – lead to a markedly higher risk of developing skin cancers.

Pre-clinical studies have demonstrated that melanocortin drugs – including afamelanotide, the active ingredient in SCENESSE®  – can increase an individual’s capacity to rejuvenate cells through the repair of damaged DNA. In 2020, CLINUVEL commenced a clinical program to confirm these findings in patients with xeroderma pigmentosum (XP) and healthy volunteers.

CUV151 study

The CUV151 study, conducted in a single expert university centre, will evaluate the effect of a single dose of SCENESSE® in ten healthy adult volunteers with Fitzpatrick skin types I-III. The volunteers will be exposed to a series of controlled light exposures throughout the study and biological samples taken to evaluate the extent of DNA damage and repair before and after SCENESSE® treatment. Volunteer enrolment will commence once restrictions due to the corona virus pandemic are lifted.

Commentary

“We are pioneering in clinically evaluating the extent of DNA damage and regeneration by using a melanocortin in healthy volunteers,” CLINUVEL’s Clinical Operations Manager, Dr Pilar Bilbao said. “Given the extensive data we have on the use of afamelanotide, our team has a level of comfort in exposing volunteers to UV damage in a controlled manner to understand if previous work can be replicated in man. We look forward to the first result in 2021.”

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