Cybin Inc. Successfully Completes Phase 2 Dosing of Promising Psilocybin Analog for Depression Treatment

NEW YORK — Cybin Inc., a psychedelic-based medical treatments, announced today the successful completion of its Phase 2 clinical trial for CYB003, a proprietary deuterated psilocybin analog. The compound is being evaluated as a potential breakthrough treatment for Major Depressive Disorder (MDD). With the trial’s conclusive data expected in the latter part of this year, Cybin is gearing up to progress to the Phase 3 stage of clinical evaluation.

The ongoing Phase 1/2 trial of CYB003 is a meticulously designed, randomized, double-blind, placebo-controlled study. It evaluates the analog in subjects with moderate to severe MDD and a control group of healthy participants. Notably, those suffering from MDD were permitted to continue their existing antidepressant treatments while participating in the study.

Throughout the trial, six distinct cohorts received varying doses of the compound, ranging between 1mg and 16mg. Encouragingly, CYB003 demonstrated commendable safety and tolerability across all dosage levels. Furthermore, there have been no reports of significant adverse events or dropouts due to side effects in the concluding cohort.

One of the pivotal assessment tools utilized in the trial is the Montgomery-Asberg Depression Rating Scale (MADRS). Widely recognized by healthcare professionals, MADRS offers an in-depth evaluation of depressive symptoms’ severity. The structured interview process probes into diverse symptoms, from sadness and tension to appetite changes and suicidal ideations. Each symptom’s severity is quantified, providing a cumulative score reflecting the patient’s overall depressive state.

Doug Drysdale, Cybin’s CEO, expressed his buoyant outlook on the promising trajectory of the CYB003 trial. “From the study’s onset to the successful completion of dosing across all Phase 2 cohorts, our team’s dedication and rigorous scientific approach have been nothing short of outstanding,” Drysdale commented. He underscored the company’s eagerness for the upcoming release of top-line efficacy data.

He further emphasized, “Our immediate priority now pivots to submitting this critical data to the U.S. Food and Drug Administration (FDA) and readying for a potential Phase 3 pivotal study, set to kick off in early 2024.”

As the Phase 2 clinical trial of CYB003 nears its conclusion, all eyes will be on the forthcoming clinical readout expected this quarter. TDR will continue to provide in-depth coverage and updates on Cybin’s endeavors and results.