Cybin Inc. Receives MHRA Approval for Second Phase 3 Trial of CYB003 in Depression Treatment

Cybin Inc. (NYSE American: CYBN) (NEO: CYBN) has announced the UK Medicines and Healthcare products Regulatory Agency (MHRA) approval to initiate the EMBRACE trial, the second pivotal study in its Phase 3 PARADIGM program. This trial will evaluate CYB003, a proprietary deuterated psilocin analog, as a potential treatment for Major Depressive Disorder (MDD). The EMBRACE trial aims to enroll 330 patients with moderate to severe MDD across 60 global sites, administering either 16 mg, 8 mg of CYB003, or a placebo, with the primary endpoint being the change in Montgomery-Asberg Depression Rating Scale (MADRS) score at six weeks.

This development follows the U.S. Food and Drug Administration (FDA) granting CYB003 Breakthrough Therapy Designation, underscoring the potential of CYB003 to address a significant unmet need in mental health treatment. Cybin's CEO, Doug Drysdale, highlighted the growing clinical and regulatory support for psychedelic-based treatments, referencing the annual run rate of $1.7 billion for esketamine as indicative of the sector's momentum. The approval of the EMBRACE trial represents a critical milestone in Cybin's mission to revolutionize mental healthcare through innovative psychedelic-based therapeutics.