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Child Psychiatrist /Adult Psychiatrist

Psilocybin Analog Gets Breakthrough Tx Status for Major Depressive Disorder

Keypoint: Treatment with 2 doses of CYB003 led to robust and sustained improvements in depression symptoms at 4 months.


Depressive Disorder

The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to CYB003, a proprietary deuterated psilocybin analog for the adjunctive treatment of major depressive disorder (MDD).


The designation was based on data from a phase 2 trial (ClinicalTrials.gov Identifier: NCT05385783) that evaluated the psychedelic-based therapeutic in patients with moderate to severe MDD. Findings showed treatment with 2 doses of CYB003 (12 mg or 16 mg) led to robust and sustained improvements in depression symptoms at 4 months.


In both dosing cohorts, the mean reduction from baseline in the Montgomery–Asberg Depression Rating Scale (MADRS) score was approximately 22 points from baseline. In the 16 mg group, roughly 75% of patients were considered responders, defined as at least a 50% improvement in MADRS score, after 2 doses. Remission rates (defined as MADRS score ≤ 10) were reported to be 60% and 75% in the 12 mg and 16 mg cohorts, respectively, following 2 doses.


“The sustained reduction in depression symptoms at the four-month mark after just 2 doses of CYB003 is a critical milestone that demonstrates the durability of the response, following the rapid improvement in symptoms,” said Amir Inamdar, MBBS, DNB (Psych), MFPM, Chief Medical Officer of Cybin. “Unlike currently approved adjunctive treatments which require chronic, daily dosing, CYB003 allows for intermittent dosing without the challenges of withdrawing patients from their existing medications.”


With regard to safety, no drug-related serious adverse events were reported in the study. Suicidal ideation or behavior were not observed during the trial period.


“Considering these positive findings, we are eager to progress the program and bring relief and treatment alternatives to the millions of people who can benefit,” added Inamdar.


The Company stated that a phase 3 trial is expected to begin in mid-2024.


This article originally appeared on MPR

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