Cybin Inc. Unveils Promising Phase 2 Results for Psychedelic Depression Treatment CYB003

Cybin Inc. a psychedelic biotech drug development, has recently announced the comprehensive results from its Phase 2 trial of CYB003, a groundbreaking treatment for Major Depressive Disorder (MDD). These findings, presented at a high-profile R&D investor briefing in New York City, have garnered significant attention from analysts, investors, the media, and the public, who could also participate via webinar.

The trial’s final Phase 2 results revealed striking improvements in depression symptoms among patients, with an average 13.75-point enhancement on the Montgomery-Åsberg Depression Rating Scale (MADRS) at 3 weeks for the combined 12mg and 16mg dosage cohorts. This scale, widely recognized by regulatory authorities globally, assesses various aspects of depression, including mood, sleep, appetite, and concentration, with a scoring system ranging from 0 to 60.

A key highlight of the trial was the incremental benefit observed from a second dose of CYB003, demonstrating a 5.8-point improvement at 6 weeks. Notably, 79% of patients showed significant responsiveness and remission following two doses at the 12mg level.

In comparison to traditional antidepressants and other psychedelics, CYB003 has shown a remarkable effect size, surpassing standard antidepressants like SSRIs and outperforming the average improvements recorded in 232 industry studies of existing antidepressants. This positions CYB003 as a potential game-changer in the treatment of depression.

The safety and tolerability profile of CYB003 was also noteworthy, with all adverse events reported being mild to moderate and self-limiting. This promising safety profile sets a strong foundation for the drug’s advancement to a more extensive, multinational Phase 3 trial scheduled for early next year.

Cybin is now gearing up for the next critical regulatory phase, planning to submit the topline data of the Phase 2 CYB003 study to the U.S. Food and Drug Administration (FDA) and request an end-of-Phase-2 meeting in the first quarter of 2024. This step is crucial for obtaining the necessary approvals and moving forward with the development of this innovative treatment.

Further insights are expected with the release of additional 12-week durability data, due in the first quarter of 2024. This upcoming data will be closely monitored and reported by TDR as it becomes available, providing a deeper understanding of CYB003’s long-term efficacy and impact on depression treatment.