Cybin Secures UK MHRA Approval for Phase 3 EMBRACE Trial of CYB003 in Major Depressive Disorder

Cybin, a clinical-stage neuropsychiatry company, has received approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) to commence the EMBRACE trial, the second pivotal study in its Phase 3 PARADIGM program. This trial will evaluate the efficacy and safety of CYB003, a proprietary deuterated psilocin analog, in patients with moderate to severe Major Depressive Disorder (MDD). The announcement underscores the increasing recognition of psychedelic-based therapies as viable treatment options for mental health conditions.

The EMBRACE trial is set to enroll 330 participants across 60 global sites, who will be administered either 16 mg or 8 mg of CYB003 or a placebo. The primary endpoint will measure the change in the Montgomery-Asberg Depression Rating Scale (MADRS) score at six weeks. This development follows the U.S. Food and Drug Administration's (FDA) granting of Breakthrough Therapy Designation to CYB003, a testament to the compound's potential to address the unmet needs in MDD treatment.

Doug Drysdale, CEO of Cybin, highlighted the significance of this milestone, pointing to the broader acceptance and regulatory support for psychedelic-based treatments. He also referenced the commercial success of esketamine, which has achieved a $1.7 billion annual run rate, as indicative of the sector's momentum. The approval of the EMBRACE trial not only advances Cybin's mission to revolutionize mental healthcare but also contributes to the growing body of evidence supporting the therapeutic potential of psychedelics.

For further details on Cybin's groundbreaking work and the EMBRACE trial, interested parties can view the full press release here.