CLINUVEL's new clinical program in Parkinson's Disease

CLINUVEL Pharmaceuticals Limited (ASX: $CUV) has announced the initiation of a novel clinical program to evaluate afamelanotide as a treatment in early-stage Parkinson's Disease (PD) in fair-skinned patients. The Phase lla CUV901 study has received ethics and regulatory approval for a 2024 start and aims to determine whether afamelanotide, through melanocortin-1 receptor (MC1R) activation, can lower a-synuclein in blood levels in PD patients and positively affect neurons of the midbrain.

CLINUVEL's Chief Scientific Officer on the clinical program

We are immensely pleased to initiate a highly innovative study for afamelanotide. It marks a real breakthrough to conduct this study in Parkinson's after lengthy regulatory discussions and preparation. At the heart of the problem in Parkinson's lies the loss of dopamine producing neurons in the brain due to toxicity caused by a-synuclein. There is now evidence that afamelanotide - by binding to MC1R - could maintain stability and integrity of the affected neurons and slow down progression of the disorder. By analysing blood and brain scans of the substantia nigra, we will learn of afamelanotide's potential effect in Parkinson's. The ability to do something for this group of patients results from decades of clinical research and a focus on translating inhouse knowledge.

CLINUVEL's clinical program and outlook

CLINUVEL's new clinical program aims to evaluate the potential of afamelanotide as a treatment in early-stage Parkinson's Disease in fair-skinned patients. The Phase lla CUV901 study, which has received ethics and regulatory approval, will focus on determining whether afamelanotide can lower a-synuclein in blood levels and positively affect neurons of the midbrain. The company aims to enrol the first patients before the end of 2024. The program is based on evidence from preclinical models showing the benefit of MC1R therapy with afamelanotide in Parkinson's Disease. If successful, this program could provide a new therapeutic option for PD patients and contribute to slowing down the progression of the disorder. CLINUVEL's focus on translating inhouse knowledge and conducting innovative studies reflects its commitment to addressing unmet medical needs and advancing treatment options for specialized patient populations.