CLINUVEL's drug afamelanotide was well tolerated by the first three arterial ischaemic stroke (AIS) patients enrolled in a world first clinical trial (CUV801). The patients experienced acute strokes due to a clot formed in the higher regions of the brain and were treated with frequent afamelanotide doses at a specialist neurological hospital in Australia. None of the patients experienced drug-related adverse events. All patients have been discharged from critical care. In total, six adult AIS patients are to be evaluated in the CUV801 study. The study focuses on the safety and therapeutic potential of afamelanotide in patients who are ineligible for standard stroke therapy. AIS accounts for approximately 85% of the 15 million strokes suffered worldwide each year, while more than 80% of these patients are ineligible for standard of care treatment. In following CUV801 study protocol, all three patients underwent close clinical monitoring during hospital stay. During this period, the neurology specialist team responsible for patient care assessed the safety of intervention with multiple doses of afamelanotide, as well as changes in neurological function and the extent of disability. Afamelanotide treatment was well tolerated by the patients, with no reports of drug-related adverse events. All patients received intermittent treatment with afamelanotide according to the CUV801 protocol. Patients' neurological functions were clinically assessed using the Modified Rankin Scale and National Institutes of Health Stroke Scale (NIHSS), while imaging of brain tissue is used to evaluate the extent of changes within the brain (CT perfusion and MRI). Two patients showed improvement in neurological deficit (NIHSS), while one patient showed no improvement. During the assessment of MRI imaging, special focus is on the blood flow (perfusion) to the affected regions of the brain (core and penumbra) following afamelanotide treatment.