Cybin wins Australian approval for phase 3 MDD study

Executive Summary

• Cybin Inc. has received regulatory approval in Australia to commence the "Embrace" pivotal Phase 3 study for CYB003, a proprietary deuterated psilocin analogue, for the adjunctive treatment of Major Depressive Disorder (MDD).
• This approval follows recent regulatory clearances in Ireland, Poland, Greece, and the United Kingdom, allowing the company to initiate the study across three continents.
• The Embrace study is a three-arm, randomized, double-blind, placebo-controlled trial expected to enroll 330 participants with moderate to severe MDD who are inadequately controlled on current antidepressants.

Key Details

• Regulatory Approvals:
  • Australia: Approved via the clinical trial notification scheme, with clearance from multiple ethics committees of the Therapeutics Goods Administration and site research governance offices.
  • Ireland, Poland, Greece: Approved by the Irish Medicines Board acting as the reference member state.
  • United Kingdom: Approved by the UK Medical and Healthcare Products Regulatory Agency.
• Study Design (Embrace):
  • Population: 330 patients with moderate to severe MDD (MADRS ≥ 24) on stable antidepressant doses with inadequate response.
  • Arms: Randomized 1:1:1 to receive CYB003 16 mg, CYB003 8 mg, or inactive placebo.
  • Dosing: Each arm evaluates 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.
• Program Context (Paradigm):
  • Total Enrollment: The Phase 3 Paradigm program aims to enroll 550 participants across three studies: Approach, Embrace, and Extend.
  • Approach Study: Currently dosing at ~45 sites in the U.S.
  • Extend Study: Long-term extension study for participants from Approach and Embrace after completing the 12-week treatment periods.
• Prior Data:
  • CYB003 received Breakthrough Therapy Designation from the US FDA for adjunctive treatment of MDD.
  • Phase 2 results showed robust 12-month improvements in depression symptoms after two 16 mg doses of CYB003.

Notable Quotes

• "Having been granted approval in Australia to commence the Embrace component of Paradigm, we are now cleared to study CYB003 on three continents... Validation from these international regulatory bodies is highly encouraging as we pursue our mission of revolutionizing mental health care by developing safe and effective treatments for a variety of mental health conditions." — Doug Drysdale, Chief Executive Officer