Cybin’s Psychedelic Drug CYB003 Demonstrates Sustained Efficacy in Reducing Depression Symptoms Over 12 Months

Efficacy:
CYB003, a proprietary deuterated psilocybin analog developed by Cybin, has shown a 100% response rate and 71% remission rate at 12 months in a Phase 2 trial for major depressive disorder (MDD)12.

Rapid and Sustained Improvement:
The drug demonstrated rapid and significant improvements in depression symptoms, evident on the day after dosing, peaking 10 days after dosing, and maintained thereafter2.

Statistical Significance:
The reduction in MDD symptoms, measured by the Montgomery-Asberg Depression Rating Scale (MADRS), was statistically significant compared to placebo, with a mean -14 point reduction from baseline2.

Breakthrough Therapy Designation:
CYB003 received FDA Breakthrough Therapy Designation, indicating it meets a significant unmet need for patients with MDD and providing expedited review pathways34.

Safety Profile:
The drug exhibited a favorable safety and tolerability profile, with predominantly mild or moderate adverse events and no serious adverse events or suicidal ideation23.

Potential Impact:
CYB003 shows promise as a significant treatment option for MDD, with efficacy data surpassing that of currently FDA-approved antidepressants, and has the potential to address the limitations of standard treatments such as SSRIs34.

Sources:

1. https://endpts.com/cybin-reports-high-remission-rates-for-psilocin-drug-in-phase-2-depression-test/

2. https://www.biospace.com/cybin-announces-unprecedented-positive-phase-2-interim-data-for-cyb003-in-major-depressive-disorder-meeting-primary-efficacy-endpoint-with-rapid-and-significant-improvements-in-depression-symptoms-after-single-dose

3. https://www.pharmacytimes.com/view/fda-breakthrough-therapy-designation-granted-to-novel-psychedelic-molecule-cyb003-for-major-depressive-disorder

4. https://ir.cybin.com/investors/news/news-details/2024/Cybin-Receives-FDA-Breakthrough-Therapy-Designation-for-its-Novel-Psychedelic-Molecule-CYB003-and-Announces-Positive-Four-Month-Durability-Data-in-Major-Depressive-Disorder/default.aspx