Cybin (CYBN) announced that it has received approval in Australia to conduct the EMBRACE study. Embrace is the second pivotal study in Paradigm, the company’s Phase 3 multinational program evaluating CYB003, a proprietary deuterated psilocin analog. The company has received approval through the Clinical Trial Notification scheme, obtained clearance from multiple Ethics Committees of the Australian Therapeutics Goods Administration, and the study site Research Governance Offices, thus allowing the commencement of the EMBRACE study. This approval follows two other recent regulatory decisions: The Irish Medicines Board, acting as the reference member state, granted approval to initiate the EMBRACE study in Ireland, Poland, and Greece; and The United Kingdom Medical and Healthcare Products Regulatory Agency approved the commencement of the EMBRACE study in the United Kingdom.
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