Cybin Receives Australian Approval for Phase 3 EMBRACE Study of CYB003 in Major Depressive Disorder

Cybin Inc. (NYSE American: CYBN) (Cboe CA: CYBN), a clinical-stage neuropsychiatry company, has received approval in Australia to conduct the EMBRACE study, the second pivotal trial in its Phase 3 multinational program evaluating CYB003, a proprietary deuterated psilocin analog. The approval was granted through the Clinical Trial Notification scheme, with clearance from multiple Ethics Committees of the Australian Therapeutics Goods Administration and Research Governance Offices, allowing initiation of the study.

The EMBRACE study represents a critical component of Cybin's PARADIGM Phase 3 program, which focuses on developing next-generation treatment options for mental health conditions. CYB003 is being evaluated for the adjunctive treatment of major depressive disorder, targeting the large unmet need for effective mental healthcare solutions. The company's approach involves developing intermittent treatments that provide long-lasting results, potentially revolutionizing the mental health treatment landscape.

This regulatory milestone enables Cybin to expand its clinical trial operations into Australia, joining its existing operational presence in Canada, the United States, the United Kingdom, the Netherlands, and Ireland. The approval through Australia's Clinical Trial Notification scheme demonstrates the country's supportive regulatory environment for innovative psychiatric research and development.

Cybin's broader development pipeline includes CYB004, a proprietary deuterated N, N-dimethyltryptamine molecule currently in Phase 2 study for generalized anxiety disorder, along with a research pipeline of investigational, 5-HT-receptor focused compounds. The company's work in deuterated psychedelic compounds represents a novel approach to mental health treatment that could address limitations of current therapeutic options.

The advancement of CYB003 into Phase 3 trials in Australia follows promising proof-of-concept data, supporting the potential of deuterated psilocin analogs as transformative treatments for mental health disorders. This development matters because it accelerates the timeline for potentially bringing new, effective treatments to patients suffering from major depressive disorder, a condition affecting millions worldwide with limited treatment options. More information about Cybin's developments is available at https://ibn.fm/CYBN.