Clinuvel Pharmaceuticals Limited announced that the first arterial ischaemic stroke (AIS) patient received treatment with PRÉNUMBRA® Instant as part of the CUV803 study, the Company's second study of afamelanotide in AIS. This Technical Note provides further detail on the current standards of care in stroke, the potential of melanocortins to treat stroke patients, and the aims of CLINUVEL's stroke program. The CUV803 study: The phase II CUV803 study aims to investigate the dose response and safety of PRÉNUMBRA® Instant (afamelanotide) in acute AIS.

The study design and protocol take key learnings from the clinical data generated in the first stroke study, CUV801, which showed that afamelanotide (16mg implant) was well tolerated by patients in a uniform dose, with the majority of patients showing a functional recovery post-treatment. The CUV803 study will provide further information on the safety and clinical benefits of afamelanotide at a higher, and more frequent, dosing regimen using a fast-acting liquid formulation. In line with the aims of CLINUVEL's stroke program, CUV803 will assess the impact of PRÉNUMBRA® Instant treatment on the ischaemic core and penumbra and will also investigate the effect on cerebral fluid based on afamelanotide's anti-oncotic and anti-oxidative properties.

Clinical evaluations: In evaluating PRÉNUMBRA® Instant in AIS patients, various clinical assessments will be made throughout the CUV803 study: Safety - Monitoring and recording treatment-emergent adverse events and concomitant medications throughout the course of the study. National Institutes of Health Stroke Scale - The validated NIHSS records the level of impairment caused by a stroke in 11 items, giving an overall assessment score between 0 (no impact) and 42 (death). Activities of Daily Living - The ADL indicates the degree of disability or dependence in the daily activities of patients who have suffered a stroke or other causes of neurological disability.

Cognition (Mini Mental State Examination, MMSE) - A 30-point cognitive assessment commonly used to assess the level of cognitive impairment following a stroke. Imaging - Patients will be evaluated through computed tomography perfusion (CTP) of the cerebrum, which will be compared to Magnetic Resonance Imaging (MRI), Diffusion Weighted Imaging (DWI) and Fluid Attenuated Inversion Recovery (FLAIR). For patients with acute arterial occlusion, computed tomography perfusion relative cerebral blood flow (CT-rCBF) maps provide a fast and accurate estimate of tissue that is likely to be irreversibly injured in acute stroke patients.