Cybin Inc. announced that its Clinical Trial Application (CTA) has been approved by the Irish Medicines Board, acting as the reference Member State, to initiate the EMBRACE study in Ireland, Poland, and Greece. This approval follows the recent clearance from the UK Medical and Healthcare products Regulatory Agency (MHRA) to commence EMBRACE in the United Kingdom.
EMBRACE is the second pivotal study in PARADIGM, Cybin’s Phase 3 multinational program evaluating CYB003, a proprietary deuterated psilocin analog, for the adjunctive treatment of Major Depressive Disorder (MDD). The study aims to enroll 330 participants who live with moderate to severe MDD and whose symptoms are inadequately controlled with antidepressant treatments.
Securing European approval validates the quality of Cybin's Phase 3 clinical development program and reaffirms the strength of its results to date. This expansion enables Cybin to leverage Europe’s established clinical trial infrastructure and broaden the research base for this critical program.
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