Cybin Reports 79% Remission in MDD with CYB003, Prepares for Phase 3 Trials

LOS ANGELES- Cybin Inc., has announced promising results from its Phase 2 study of CYB003, a proprietary deuterated psilocybin analog developed for the treatment of major depressive disorder (MDD). The study demonstrated that 79% of patients achieved remission from depression symptoms six weeks after receiving two 12mg doses of CYB003.

The trial also reported rapid and significant improvements in depression symptoms following a single dose of CYB003. Patients experienced an average reduction of 13.75 points on the Montgomery–Åsberg Depression Rating Scale (MADRS) at the three-week mark, a statistically significant difference from the placebo group. The administration of a second dose at six weeks resulted in an additional 5.8-point improvement on the MADRS total score.

These findings suggest that CYB003 may offer a more effective treatment option for MDD compared to traditional antidepressants, which typically show an average improvement of 1.82 points on the MADRS total score versus placebo.

Cybin plans to submit these topline data to the U.S. Food and Drug Administration (FDA) and request an end-of-Phase 2 meeting in early 2024. The company anticipates initiating a multinational, multisite Phase 3 study of CYB003 in early 2024, with recruitment expected to begin by the end of the first quarter.

Regarding the mention of “Gaetz’s Appointment,” there is no publicly available information linking Representative Matt Gaetz to Cybin Inc. or its clinical trials. It is possible that this refers to an internal appointment within the company or a misinterpretation of available data.