Cybin Inc. announced that it has received approval in Australia to conduct the EMBRACE study, the second pivotal study in its Phase 3 PARADIGM multinational program. This program is evaluating CYB003 for the adjunctive treatment of Major Depressive Disorder (MDD).
The approval was granted through the Clinical Trial Notification scheme and cleared by multiple Ethics Committees of the Australian Therapeutics Goods Administration. This allows for the commencement of the EMBRACE study in Australia, following previous approvals in Ireland, Poland, Greece, and the United Kingdom.
The EMBRACE study is expected to enroll 330 participants at approximately 60 clinical sites across the U.S., Europe, and Australia. This international expansion builds on the extraordinary 12-month Phase 2 results for CYB003, which showed robust improvements in depression symptoms after two 16 mg doses.
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