Unprecedented 12-Month Efficacy of CYB003 for Major Depressive Disorder

Unprecedented 12-Month Efficacy of CYB003 for Major Depressive Disorder

November 18, 2024 Catherine Williams - Chief Editor Health

Cybin Inc. Announces Positive Results for CYB003 Treatment of Major Depressive Disorder

Key Highlights:

  • 100% of participants responded to treatment with CYB003.
  • 71% were in remission 12 months after receiving two 16 mg doses.
  • Average score reduction of ~23 points on the MADRS compared to baseline after 12 months.

Treatment Details:

  • CYB003 received Breakthrough Therapy Designation from the FDA.
  • The treatment involves two doses of 16 mg, spaced three weeks apart.
  • Findings support the long-term durability of CYB003’s effects.

Safety Profile:

  • CYB003 shows excellent tolerance and safety.

Upcoming Phase 3 Trials:

  • Cybin has initiated the Phase 3 PARADIGM program to evaluate CYB003’s efficacy and safety further.

Expert Insights:
Amir Inamdar, Cybin’s Chief Medical Officer, said, “The response and remission rates are impressive. The treatment offers sustained relief for MDD patients.” He highlighted the potential to address a significant unmet need in mental health care.

Doug Drysdale, CEO of Cybin, noted the importance of transitioning to intermittent treatments over traditional daily medications, which often only provide symptom relief.

Efficacy Data Summary:

  • 16 mg Dose:

    • Mean MADRS change: ~23 points (n=7).
    • 100% response rate.
    • 71% remission rate.
  • 12 mg Dose:
    • Mean MADRS change: ~18 points (n=10).
    • 60% response rate.
    • 50% remission rate.

Future Plans:
Cybin plans to report results for CYB004, their deuterated DMT program for anxiety disorders, in early 2025.

Conference Call:

  • Date: November 18, 2024
  • Time: 8:00 a.m. ET
  • Dial-in: 800-579-2543 (U.S. Toll-Free) or 785-424-1789 (International)
  • Conference ID: CYBN1118

For more details, visit Cybin’s investor relations page.

About Cybin:
Cybin aims to transform mental health treatment with innovative options targeting major depressive disorder and anxiety disorders. With research in various compound treatments, Cybin is set to change how mental health conditions are managed.

Contact Information:
Investor & Media Contact:
Gabriel Fahel
Chief Legal Officer
Cybin Inc.
1-866-292-4601
irteam@cybin.com
media@cybin.com

For further information, visit www.cybin.com.