Psychedelics company Cybin Inc. (NYSE: CYBN) shared its Phase 2 study interim results for its psilocybin analog CYB003 on Major Depressive Disorder (MDD) paired with the company’s EMBARK psychotherapy.
The new data met the trial’s primary efficacy endpoint: A rapid, robust and statistically significant reduction in depression symptoms three weeks after a single 12mg dose of the company’s deuterated compound (n=15,) as compared to placebo (n=6.) The difference between the two groups is reportedly unprecedented -14.08 points on the MADRS scale.
These results take considerable relevance vis-a-vis a 2022 study showing data from 232 industry studies of current standard-of-care antidepressants (SSRIs) submitted to the FDA, where the average improvement was 1.82 points vs. placebo to which the benefits of CYB003’s intermittent dosing (vs. daily) would be added.
Results
Of total 21 participants, 53.3% showed a robust response; 20% were in remission three weeks after the single 12mg dose, vs. 0% in the placebo group.
Symptoms improvement reached a peak at 10 days post-dosing and maintained for ...