Clinuvel Pharmaceuticals Ltd. announced the completion of manufacture of the first cGMP batch of PRÉNUMBRA® Instant, an immediate-release liquid injectable presentation of afamelanotide. The product will first be evaluated in patients who have suffered arterial ischaemic stroke (AIS). Pathway to market: The next stage is for manufacturing processes to be scaled up, followed by manufacturing validation work generating data for the regulatory dossiers to be submitted in the United States and European Union.

Since data from preclinical studies and long-term clinical use of the SCENESSE® (afamelanotide 16mg) implant are available, a full development of PRÉNUMBRA® Instant is not required. Rapid validation of the specifications and batch release testing of PRÉNUMBRA® Instant is possible due to the extensive existing SCENESSE® dossier. The American and European pathway to marketing approval for PRÉNUMBRA Instant.

PRÉNUMBRA® Instant, new dosage form CLINUVEL has completed the manufacture of clinical trial supplies of PRÉNUMBRA® Instant under Good Manufacturing Practice (cGMP) via an exclusive arrangement with a contract manufacturing organization. The use of the fast-releasing formulation of afamelanotide provides flexibility in acute care, allowing physicians to adapt the patient's dose according to individual needs. Specialized neurology centres have been selected and engaged as clinical trial sites for CLINUVEL's second study of afamelanotide in stroke patients (CUV803), which will be the first to prescribe the PRÉNUMBRA® Instant formulation.

CUV803 will commence following regulatory and ethics consent. CLINUVEL's melanocortin portfolio: Having commercialised the first afamelanotide formulation - the 16mg SCENESSE® controlled-release implant - CLINUVEL has retained extensive expertise on the therapeutic potential of the drug, plus the broader melanocortin family. The development of melanocortins and their various formulations is part of the Company's strong focus, risk management, and diversification.

Thereby, the red line running through R&D is to lead clinical development based on populations in highest need of treatment or care.