Cybin Inc. Receives EU Approval for EMBRACE Phase 3 MDD Study

Cybin Inc. (NYSE American: CYBN) (Cboe CA: CYBN), a clinical-stage neuropsychiatry company, has announced the European approval to initiate its EMBRACE(TM) Phase 3 study in Ireland, Poland, and Greece. This study is a critical component of the Company’s PARADIGM(R) program, which focuses on evaluating CYB003, a proprietary deuterated psilocin analog that has been granted Breakthrough Therapy Designation by the FDA for Major Depressive Disorder (MDD). The EMBRACE study aims to enroll 330 participants with inadequately controlled MDD symptoms across multiple international sites, assessing two CYB003 dose levels against placebo.

The approval marks a pivotal moment in the development of new treatment options for MDD, a condition that affects millions worldwide and for which current treatments often fall short. CYB003 represents a novel approach in the treatment of mental health conditions, offering the potential for intermittent treatments with long-lasting results. The study’s outcomes could significantly impact the mental health treatment landscape, providing hope for those who have not found relief with existing therapies.

Cybin’s commitment to revolutionizing mental healthcare is further evidenced by its pipeline of investigational, 5-HT-receptor focused compounds, including CYB004, a proprietary deuterated N, N-dimethyltryptamine molecule currently in a Phase 2 study for generalized anxiety disorder. The Company’s innovative approach to mental health treatment underscores the importance of the EMBRACE study and its potential to address the large unmet need in mental healthcare.

For more information on Cybin Inc. and its groundbreaking work in neuropsychiatry, visit https://www.cybin.com. To view the full press release regarding the EMBRACE Phase 3 study, visit https://ibn.fm/TnWsD.