Cybin receives European OK for Embrace depression trial

Executive Summary

• Cybin Inc. received Clinical Trial Application (CTA) approval from the Irish Medicines Board to initiate the "Embrace" Phase 3 multinational study for CYB003 in Ireland, Poland, and Greece.
• This follows recent approval from the UK MHRA to commence the same study in the United Kingdom, expanding the geographic scope of the pivotal Paradigm program.
• The Embrace study is designed to enroll 330 participants with moderate to severe Major Depressive Disorder (MDD) who have inadequate response to current antidepressant treatments.

Key Details

• Regulatory Approvals:
  • Approved by the Irish Medicines Board (acting as reference member state) for Ireland, Poland, and Greece.
  • Previously approved by the UK MHRA for the United Kingdom.
• Study Design (Embrace):
  • Objective: Evaluate CYB003 as an adjunctive treatment for MDD.
  • Population: 330 patients with moderate to severe MDD, on stable antidepressant doses but responding inadequately.
  • Randomization: 1:1:1 ratio to receive CYB003 16 mg, CYB003 8 mg, or inactive placebo.
  • Dosing: Two doses administered three weeks apart.
  • Primary Endpoint: Change in depressive symptoms measured by MADRS from baseline at six weeks after the first dose.
  • Sites: Approximately 60 clinical sites across the U.S., Europe, and Australia.
• Paradigm Program Overview:
  • Total expected enrollment: 550 participants across three studies.
  • Approach: Phase 3 trial currently dosing at ~45 sites in the U.S.; patient rollover into the extension study is ongoing.
  • Embrace: Phase 3 trial (described above).
  • Extend: Long-term extension study for participants from Approach and Embrace after completing the 12-week double-blind, placebo-controlled treatment periods.
• Drug Status:
  • CYB003 is a proprietary deuterated psilocin analog.
  • Received Breakthrough Therapy Designation from the U.S. FDA for adjunctive treatment of MDD.
  • CYB004 (deuterated N,N-dimethyltryptamine) is in Phase 2 for generalized anxiety disorder.

Notable Quotes

• "Securing European approval to commence the Embrace component of Paradigm -- especially on the heels of the recent U.K. MHRA approval -- validates the quality of our phase 3 clinical development program and reaffirms the strength of our results to date," said Doug Drysdale, chief executive officer of Cybin.
• "With this additional approval, which enables us to enroll participants in Ireland, Poland and Greece, we are pleased to expand the reach for this critical research. The rise in mental health disorders knows no borders, and we are committed to an international research base to develop new and more effective treatments for MDD patients everywhere."