A Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Xeroderma Pigmentosum C and V

A Proof of Concept, Phase IIa, Open Label Study to Evaluate the Safety and Efficacy of Subcutaneous Implants of Afamelanotide in Patients With Xeroderma Pigmentosum C and V (XPC and XPV)

The CUV152 study will evaluate the safety of afamelanotide in XP-C and XP-V patients, as well as the drug's ability to assist reparative processes following ultraviolet (UV) provoked DNA damage of the skin. It will assess whether SCENESSE® increases the amount of UV light needed to cause DNA damage of skin cells, as well as the extent of skin repair before and after treatment.

Inclusion Criteria:

• Male or female patient with a molecular-genetically confirmed diagnosis of XP-C or XP-V;
• Aged 18-75 years.

Exclusion Criteria:

• Known allergy to afamelanotide or the polymer contained in the implant;
• Presence of severe hepatic disease or hepatic impairment;
• Renal impairment;
• Any other medical condition which may interfere with the study protocol;
• Existing melanoma;
• Female who is pregnant or lactating;
• Females of child-bearing potential (pre-menopausal, not surgically sterile) not using adequate contraceptive measures;
• Sexually active man with a partner of child-bearing potential who is not using adequate contraceptive measures;
• Use of any other prior and concomitant therapy which may interfere with the objective of the study;
• Participation in a clinical trial for an investigational agent.