Next-generation psychedelics biotech Cybin Inc. (NYSE: CYBN) released the full Phase 2 trial results of its deuterated psilocybin derivative CYB003 for Major Depressive Disorder (MDD.) Although a relatively small trial, outcomes for the novel psychedelic are so far showing strong treatment efficacy after a single dose and “a clear incremental benefit” following a second one.
The new topline, follow-up data reaffirms interim results published in October:
At three weeks: One 12mg dose of CYB003 showed a rapid, robust and clinically significant reduction of depression symptoms (primary efficacy endpoint achieved.) Specifically, 12mg and 16mg CYB003 cohorts combined showed a mean 13.75 score on MADRS* vs. placebo (24 participants on CYB003 and 10 on placebo.)
At six weeks: Two 12mg doses of CYB003 showed incremental reductions in 79% of patients in remission from depression. Specifically, it propelled an additional 5.8 point improvement on MADRS total score (22 participants on CYB003 and 10 on placebo.)
Favorable safety and tolerability profile, all reported adverse events at all doses tested being mild to moderate and self-limiting.
*The Montgomery–Åsberg Depression Rating Scale (MADRS) is a ten-item questionnaire used by psychiatrists to measure the severity of depressive episodes widely accepted by regulatory authorities as a standardized testing metric. The system involves scores 0-6, with a total score outcome from 0 to 60.
CYB003 Vs. Antidepressants
When compared to conventional ...