Pharma Focus Europe

Cybin Commences Dosing of Last Cohort in Phase 2 Trial of CYB003 for Major Depressive Disorder

Thursday, August 03, 2023

Cybin Inc. (NYSE American: CYBN) (NEO: CYBN) is making significant strides in its commitment to revolutionize mental healthcare through the development of innovative psychedelic-based treatment options. The company recently announced the initiation of dosing in Cohort 6, which marks the final stage of its Phase 2 study evaluating CYB003, an investigational deuterated analog of psilocybin intended for the treatment of major depressive disorder (MDD).

Encouragingly, the first five cohorts, receiving doses ranging from 1mg to 12mg of CYB003, completed dosing with no serious adverse events or subject discontinuations due to adverse effects. All adverse events reported were mild to moderate and resolved without the need for clinical intervention, and there were no unexpected treatment emergent adverse events observed throughout the study.

Doug Drysdale, the Chief Executive Officer of Cybin, expressed enthusiasm as the Phase 2 study approaches its conclusion. He expressed satisfaction with the excellent safety data for CYB003 and looks forward to reporting efficacy topline data later this year. Cybin aims to submit the Phase 1/2a data to the U.S. Food and Drug Administration (FDA) for pivotal studies following the topline efficacy data readout.

The upcoming milestones for the CYB003 program include the completion of dosing in MDD cohorts expected in the third quarter of 2023 and the release of topline efficacy data in the third or fourth quarter of the same year.

The Phase 1/2a CYB003 trial is a randomized, double-blind, placebo-controlled study involving participants with moderate to severe MDD and healthy volunteers. A protocol amendment introduced healthy volunteers for lower (sub-therapeutic) dose cohorts and added a bioequivalence cohort to facilitate the transition to pivotal studies. The trial aims to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and psychedelic effect of ascending oral doses of CYB003.

For participants with MDD, the trial will assess the rapid onset of antidepressant effects on the day of dosing, measure the response and remission three weeks after each dose, and evaluate the potential benefits of a second dose administered at Week 3. The study will also include an optional period of assessment to determine the durability of the treatment effect up to 12 weeks.

The study is listed on ClinicalTrials.gov under Identifier: NCT05385783. Cybin's progress in advancing CYB003 brings hope for improved treatment options for individuals suffering from major depressive disorder.

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