A Proof of Concept Study to Evaluate the Safety of Afamelanotide in Patients With Acute Arterial Ischaemic Stroke (AIS)

Inclusion Criteria: * Male or female subjects with a diagnosis of first AIS due to distal \[M2 segment and beyond\] occlusion or perforator occlusion * Perfusion abnormalities observed on Computed Tomography Perfusion (CTP) * Mild to moderate stroke severity * Pre-stroke mRS \<4 * Written informed consent obtained from patient and/or medical treatment decision maker prior to study-start (upon admission). Exclusion Criteria: * Administration of intravenous thrombolytic therapy in distal occlusion as etiology of AIS * Intervention by endovascular thrombectomy (EVT) * Known allergy or anaphylaxis to adrenocorticotropic hormone (ACTH) or melanocortins or any of the excipients listed in the Investigator's Brochure * Any evidence of hepatic (defined as three times standard range) or renal impairment (defined as estimated glomerular filtration rate (eGFR) \<50 mL/min/1.73 m²) * Any other medical condition which may interfere with the study protocol * Female who is pregnant (confirmed by positive serum beta human chorionic gonadotropin (β-HCG) pregnancy test prior to baseline) or lactating * Females of child-bearing potential (pre-menopausal, not surgically sterile) not using adequate contraceptive measures (i.e. oral contraceptives, diaphragm plus spermicide, intrauterine device) or a lifestyle excluding pregnancy * Unable to undergo MRI brain evaluation * Not suitable for trial participation according to judgment of the Principal Investigator (PI) * Patients starting afamelanotide 24 hours or more from ictus.