CYB003
CYB003: Deuterated Psilocin Program with FDA Breakthrough Therapy Designation
CYB003 is a proprietary deuterated psilocin molecule. Psilocin is part of a family of molecules called indoleamines that are structurally similar to neurotransmitters such as serotonin, and acts as a 5-HT2A receptor agonist.
CYB003 is a new chemical entity (NCE) and has been granted FDA Breakthrough Therapy Designation for the adjunctive treatment of Major Depressive Disorder (MDD).
Development Status: Initiated APPROACH, the first pivotal study in Cybin’s Phase 3 PARADIGM program in participants with moderate to severe MDD
Upcoming Milestones in 2024: Initiate second pivotal study, EMBRACE around mid-2025
PARADIGM: CYB003 Phase 3 Pivotal Program in MDD
The pivotal program will consist of 2 studies plus an extension study:
• APPROACH: Two-arm study of two doses of CYB003 vs. placebo
• EMBRACE: Three-arm study with a high dose, mid-dose, and placebo arm
• EXTEND: Long-term extension study that allows for open-label dosing or re-dosing for participants who did not respond in the first two studies or relapsed during the extension study
Expanded Access Policy
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Discover Cybin’s complete Research and Development Progress.
CYB003 received the first known Breakthrough Therapy Designation for an adjunctive tryptamine-based therapy for MDD
This designation acknowledges the significant unmet medical need for more effective treatment of MDD. It also provides validation that Phase 2 data for CYB003 shows preliminary evidence for significant clinical improvements over existing therapies.
Breakthrough Therapy Designation expedites the development pathway for CYB003 with the following benefits:
Breakthrough Therapy Designation benefits:
- All Fast Track Designation features, including Rolling Review for NDA
- More intensive FDA guidance and discussion, including planned clinical trials and plans for expediting manufacturing development strategy
- CYB003 is eligible for Priority Review and Accelerated Approval
CYB003 is in development as an acute, adjunctive therapy, with the potential to offer the following benefits:
- Allows for immediate treatment without waiting to withdraw from background medications
- Prevents withdrawal symptoms, which could be severe for some patients after years of antidepressant use
- Eliminates logistical hurdles associated with titrating off existing medications
- Background medications could provide some benefit even if inadequate alone
Clinical Validation for CYB003 in MDD:
Robust and Sustained Remission Rates up to 12 Months
12 month Data Highlights, after 2 doses of CYB003 (16 mg):
Mean ~23-point reduction in MADRS scores from baseline
Average baseline MADRS score was ~32
100% of patients were responders
71% of patients were in remission
All reported AEs mild to moderate; no AEs of suicidality
No AEs/SAEs reported in the 12 month follow up
Large Improvement in Depression Symptoms After a Single Dose of CYB003
Response and Remission at 12 Months: 12 mg & 16 mg
