Phase II interim data for psilocybin analog CYB003 in major depressive disorder (MDD) showed rapid, robust, and clinically significant reduction of depression symptoms.
Of the trial participants, 53.3% responded and 20% are in remission (i.e. no longer meeting the clinical definition of depression) after a single 12mg dose.
At the three-week primary efficacy endpoint, the reduction in MDD symptoms, defined as change from baseline in MADRS total score, was superior in participants assigned to CYB003 compared to the participants who received placebo by 14.08 points.
The MADRS is a 10-item, clinician-administered scale designed to measure overall severity of depressive symptoms in subjects with MDD. It includes items ranging from sadness of mood, reduction in sleep and appetite, to difficulties in concentration, anhedonia, and negative and suicidal thoughts that are scored from 0 to 6 giving a total score ranging from 0 to 60.
Typical score ranges for severity are: 0-6 normal; 7-19 mild; 20-34 moderate; and >34 severe depression. In the CYB003 study, mean baseline total scores on the MADRS were 32.6 and 33.3 in the active and placebo groups, respectively.
“The overwhelmingly positive interim results for the 12mg dose of CYB003 are extremely encouraging for patients and providers. The efficacy demonstrated at that dosage showed an unprecedented reduction in depressive symptoms compared to currently available treatments,” said Doug Drysdale, Chief Executive Officer of Cybin.
“This is an exciting time – not only for Cybin, but for the entire psychedelics sector – as we now have interim results showing a significant improvement in depressive symptoms with a single dose, moving us ever closer to delivering on our mission to improve the treatment landscape across the spectrum of mental health disorders,” concluded Drysdale.