A Proof of Concept, Phase IIa, Open Label Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients with Early Parkinson's Disease

Prior treatment

• Participation in any clinical intervention study during the six weeks before the study screening period.
• Any medical condition or illness in the four weeks before the study screening which may interfere with the study protocol or not suitable for study participation in the opinion of the Investigator.

Other illness

• History of drug abuse, licit or illicit.
• Any personal or immediate family history of melanoma or personal history of dysplastic nevus syndrome
• Known allergy or anaphylaxis to adrenocorticotropic hormone (ACTH) or melanocortins
• Any evidence of hepatic insufficiency or renal impairment.

Other

• Heavy alcohol consumption.
• Current cigarette smokers.
• Female who is pregnant or lactating.
• Females of child-bearing potential not using highly effective contraceptive measures, for up to three months after the last injection administration.
• Sexually active men with a partner of child-bearing potential who is not using highly effective contraceptive measures.

• Patient diagnosed with PD less than three years prior to first screening visit and not yet requiring dopaminergic medication nor expected to within three months of enrolment.
• 40-85 years old