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

Published

- Interim readout shows rapid, robust, and clinically significant reduction of depression symptoms three weeks after a single 12mg dose, with an unprecedented mean -14 point Montgomery-Asberg Depression Rating Scale (“MADRS”) score reduction from baseline between CYB003 (12mg) vs. placebo (p= 0.0005) -

- For reference, pooled data from 232 industry studies of current standard of care antidepressants, selective serotonin reuptake inhibitors (SSRIs), submitted to U.S. Food and Drug Administration (“FDA”) (Stone et al, 2022) show an average improvement of 1.82 points vs. placebo -

- Robust response and remission three weeks after single dose, with 53.3% of patients responding and 20% of patients in remission (no longer meeting the clinical definition of depression) vs. 0% for placebo -

- Favorable safety and tolerability profile with no treatment-related serious adverse events at 12 mg dose -

- Full topline data on track for Q4 2023 -

- Company to host conference call to discuss CYB003 interim results on Wednesday, November 1, 2023 at 11:00 a.m. ET

This news release constitutes a “designated news release” for the purposes of Cybin’s prospectus supplements each dated August 23, 2023, to its short form base shelf prospectus dated August 17, 2023.

TORONTO--(BUSINESS WIRE)-- Cybin Inc. (NYSE American:CYBN) (NEO:CYBN) (“Cybin” or the “Company”), a clinical-stage biopharmaceutical company committed to revolutionizing mental healthcare by developing new and innovative next-generation psychedelic treatment options, today announced Phase 2 interim results for CYB003, its proprietary deuterated psilocybin analog, demonstrating a rapid, robust and statistically significant reduction in symptoms of depression three weeks following a single 12mg dose compared to placebo. At the 3-week primary efficacy endpoint, the reduction in major depressive disorder (“MDD”) symptoms, defined as change from baseline in MADRS total score, was superior in participants assigned to CYB003 compared to the participants who received placebo by 14.08 points (p=0.0005, Cohen’s d=2.15). A p-value indicates statistical significance. Generally, values

In This Story

CYBN