Cybin Completes Phase 2 Dosing Study For Major Depressive Disorder

Cybin Inc. positive news cycle keeps churning out positive developments. Today, the company announced the successful completion of dosing for the final cohort within the Phase 2 investigation of CYB003, its proprietary deuterated psilocybin analog for the treatment of major depressive disorder (MDD). With readout data anticipated in the fourth quarter of this year, Cybin is preparing to advance the trial to the Phase 3 stage.

Cybin’s Phase 1/2 trial is a randomized, double-blind, placebo-controlled study is assessing CYB003 in participants with moderate to severe MDD and healthy volunteers. Healthy volunteers received two administrations (placebo/active and active/active) one week apart, with assessments of psychedelic effects after each dose. Participants with MDD received two administrations (placebo/active and active/active) three weeks apart, and response/remission were assessed three weeks after each dose. Participants currently receiving antidepressant medication for MDD treatment are allowed to continue.

The six cohorts were administered different doses, ranging from 1mg to 16mg, and thus far, CYB003 has exhibited safety and tolerability across all dose levels, with no reports of serious adverse events or discontinuations due to adverse events in the final cohort.

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The trial aims to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and psychedelic effects of ascending oral CYB003 doses. For MDD participants, the study will also assess the rapid onset of antidepressant effects on the dosing day using the Montgomery-Asberg Depression Rating Scale (MADRS) and evaluate the added benefit of a second CYB003 dose when administered at Week 3. An optional assessment period will determine the treatment’s durability up to 12 weeks.

MADRS is a clinical assessment tool used by healthcare professionals to measure the severity of depressive symptoms in individuals who have been diagnosed with depression. It consists of a structured interview in which the clinician asks the patient a series of questions to evaluate their mood and emotional state.

The questions cover a range of symptoms commonly associated with depression, such as sadness, tension, sleep disturbances, appetite changes, concentration difficulties, and suicidal thoughts. Each symptom is rated on a scale from 0 to 6 or 0 to 7, with higher scores indicating more severe symptoms. The total score is calculated by summing the individual item scores, and it provides an overall measure of the severity of depression.

Doug Drysdale Expresses Enthusiasm For Trial Trajectory

In a statement, Cybin CEO Doug Drysdale expressed his enthusiasm for the remarkable strides made in their journey. He highlighted the swift transition, starting from the inception of the study to the successful dosing completion across all Phase 2 CYB003 Major Depressive Disorder (MDD) cohorts. With eager anticipation, the company now looks forward to the imminent release of the top-line efficacy data later in the year.

Mr, Drysdale emphasized that their foremost focus is on the forthcoming submission of this crucial data to the U.S. Food and Drug Administration , as well as the preparations for a potential Phase 3 pivotal study scheduled for early 2024.

TDR will have additional coverage on Cybin’s CYB003 trial winds down and the anticipated clinical readout is reported in this quarter.


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