CLINUVEL's drug afamelanotide has been administered to a first patient diagnosed with an acute arterial ischaemic stroke (AIS) enrolled in a world's first clinical trial (CUV801). Due to a clot formed in the higher region of the left
middle cerebral artery (M2 or above), the patient suffered an acute stroke and was admitted to a specialist neurological hospital in Australia to receive treatment. In total, six adult AIS patients will be evaluated in the Phase II CUV801 study. The study focuses on the safety and therapeutic potential of afamelanotide in patients who are ineligible for standard stroke therapy. Scientific progress has demonstrated melanocortins, including afamelanotide, provide a positive effect on the central nervous system (CNS). Afamelanotide is known to offer neuroprotection and act as a potent anti- oxidative hormone. The drug possesses further therapeutic benefits, activating vessels, reducing fluid formation, protecting critical nerve and brain tissue, and restoring the blood brain barrier (BBB: a critical defence mechanism protecting the brain). The drug therapy is expected to affect the blood flow and oxygen to deprived brain tissue. The CUV801 study is evaluating the use of afamelanotide in six patients who suffered an acute stroke, with a main focus on safety monitoring following drug administration as they are admitted to hospital. Following multiple dosing, patients enrolled in the study are clinically assessed to detect changes or improvement in neurological functions and activities of daily living. Validated clinical tools, the Modified Rankin Scale and National Institutes of Health Stroke Scale, are used to evaluate the extent of patients' disability. Through a number of periodic magnetic resonance imaging (MRI) brain scans, the blood volume and flow to the affected regions of the brain are assessed, with a special attention to the core of the stroke (infarct) and penumbra.