Cybin Inc. (NYSE American:CYBN) (NEO:CYBN), one of the leading public psychedelic biotech drug developers, released full CYB003 Phase 2 trial results for Major Depressive Disorder (MDD). The deuterated psilocybin derivative achieved strong follow-up results, which reaffirmed interim data released on October 31. With efficacy and safety established in a small patient cohort, Cybin now prepares for a more expansive Phase 3 trial scheduled to commence next year.
Cybin showcased the dataset in front in a R&D investor briefing in New York City this morning. Analysts, investors and the media where present, and the general public were able to participate via webinar.
The final Phase 2 topline efficacy data unveiled rapid and substantial improvements in depression symptoms, emphasizing an average 13.75-point improvement on MADRS at 3 weeks for the 12mg and 16mg cohorts combined. Furthermore, the incremental benefit of a newly-reported second dose was evident, showcasing a 5.8-point improvement on the MADRS total score at 6 weeks.
Widely accepted by regulatory authorities worldwide as a metric for standardized testing, MADRS includes items ranging from mood-related sadness, sleep and appetite changes, concentration difficulties and more. The tally-style scoring system consists of scores ranging from 0 to 6, with a total score outcome ranging from 0 to 60.
Overall, a full 79% of patients exhibited responsiveness and remission after two doses of CYB003 at the 12mg dose.
A single 12mg dose of CYB003 showed a rapid, robust, and highly statistically significant improvement in depression symptoms compared to placebo, with a -14.08 point difference in change from baseline in MADRS (p=0.0005, Cohen’s d=2.151). This translated into a very large effect size. Similar significant and robust effects were also seen with a single 16mg dose, which resulted in an improvement in symptoms of depression as measured using the MADRS total score by about 13 points versus placebo.
Amir Inamdar, MBBS, DNB (Psych), MFPM, Chief Medical Officer of Cybin
Noteworthy is the comparison of CYB003’s effects to conventional antidepressants and other psychedelics. The data revealed an unprecedented effect size, far surpassing standard antidepressants such as SSRIs. In fact, the magnitude of improvement exceeded the average improvement reported in 232 industry studies of current antidepressants.
In terms of safety and tolerability, CYB003 demonstrated an excellent profile in the tested doses, with all reported adverse events being mild to moderate and self-limiting. These results not only mark a substantial advancement in depression treatment but also provide a solid foundation for the progression of CYB003 to a multinational, multisite Phase 3 study scheduled for early next year.
Cybin now prepares for the next regulatory step by submitting the topline data of its Phase 2 CYB003 study to the U.S. Food and Drug Administration (FDA). Simultaneously, the company is planning to request an end-of-Phase-2 meeting with the FDA in the first quarter of 2024.
TDR will have additional coverage on additional 12-week durability data, due in Q1 2024, as it becomes available.
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