Cybin completes enrolment in phase 2 study on CYB004

Executive Summary

• Cybin Inc. has completed enrollment in its Phase 2 study (CYB004-002) evaluating CYB004, a proprietary deuterated dimethyltryptamine (DMT) program, for the treatment of generalized anxiety disorder (GAD).
• The company reaffirms its guidance for top-line data from this study to be released in the first quarter of 2026.
• CYB004 is being evaluated for its potential to offer convenient intramuscular dosing for patients with GAD, a condition affecting millions globally with significant unmet treatment needs.

Key Details

• Study Completion: Enrollment for the CYB004-002 Phase 2 study is complete.
• Data Guidance: Top-line data is expected in Q1 2026.
• Study Design: Randomized, double-blind study evaluating safety and efficacy of CYB004 in participants with moderate to severe GAD (GAD-7 score ≥ 10) who are currently taking concomitant antidepressant or anxiolytic treatments.
• Population: Participants with co-morbid depression are allowed.
• Enrollment: 36 participants enrolled, randomized 2:1 into two groups.
• Dosing Regimen:
  • Group 1 (Therapeutic): Two intramuscular administrations of 20-milligram CYB004, three weeks apart.
  • Group 2 (Subtherapeutic): Two intramuscular administrations of 2-milligram CYB004, three weeks apart.
• Primary Endpoint: Change in HAM-A (Hamilton Anxiety Rating Scale) score from baseline at six weeks following the first administration.
• Secondary Endpoints: Change in HAM-A through the double-blind period (Week 12).
• Other Endpoints: HAM-D (Hamilton Depression Rating Scale), safety assessments, MEQ30 (psychedelic experience assessment), and EQ-5D-5L (quality of life assessment).
• Follow-up: Optional follow-up to assess efficacy at 12 months; study remains double-blinded through Week 12.
• Company Pipeline Context: Cybin is also developing CYB003 (deuterated psilocin analogue) in Phase 3 for major depressive disorder (MDD), which has received FDA Breakthrough Therapy designation.

Notable Quotes

• "Completing enrolment in our phase 2 study of CYB004 marks a significant milestone on our path to bringing forth an effective treatment for GAD," said Eric So, interim chief executive officer of Cybin.
• "We are excited about CYB004, and its potential to offer convenient intramuscular dosing for patients in need. We are proud of this work to date, as well as the robust patent protection in support of our CYB004 program and we look forward to sharing top-line data in the first quarter of 2026."