Cybin Inc. (NYSE American:CYBN / NEO:CYBN), a clinical-stage biopharmaceutical company committed to revolutionizing mental healthcare by developing new and innovative psychedelic-based treatment options, today announced that it has initiated dosing in Cohort 6, the final cohort of its Phase 2 study evaluating CYB003, an investigational deuterated analog of psilocybin for the potential treatment of major depressive disorder (“MDD”).

The first five cohorts, which dosed 1mg, 3mg, 8mg, 10mg, and 12mg of CYB003, have completed dosing with no serious adverse events and no subject discontinuations due to adverse events. All adverse events reported in the cohorts completed to date were mild to moderate and resolved without the need for any clinical intervention. To date, no unexpected treatment emergent adverse events have been observed.

“As we begin the final dose escalation cohort in our Phase 2 study, we are moving closer than ever towards our goal of determining an optimal dose for CYB003 and assessing CYB003’s potential as a safe and effective therapeutic for people in need of improved treatment options for major depressive disorder. We are very pleased with the excellent safety data for CYB003 in participants to date and look forward to reporting Phase 2 efficacy topline data later this year and preparing for data submission to the FDA for pivotal studies.”

Doug Drysdale, Chief Executive Officer of Cybin

Upcoming milestones for the CYB003 program:

  • Completion of CYB003 dosing in MDD cohorts expected in Q3 2023
  • Topline efficacy data readout from CYB003 Phase 2 clinical trial expected in Q3/Q4 2023
  • U.S. Food and Drug Administration (“FDA”) submission of CYB003 Phase 1/2a data for pivotal studies expected following topline efficacy data readout

About the Phase 1/2a CYB003 Trial

The Phase 1/2a trial is a randomized, double-blind, placebo-controlled study evaluating CYB003 in participants with moderate to severe MDD and in healthy volunteers. Per a protocol amendment that was announced on February 28, 2023, the study introduced healthy volunteers for the lower (sub-therapeutic) dose cohorts and added a bioequivalence cohort to facilitate the transition to pivotal studies. Healthy volunteers receive two administrations (placebo/active and active/active) one week apart, and measures of psychedelic effect are assessed after each dose. Participants with MDD receive two administrations (placebo/active and active/active) three weeks apart and response/remission are assessed three weeks after each dose. MDD participants in the trial that are currently being treated with antidepressants will be allowed to remain on their antidepressant medication.

The study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics, and psychedelic effect of ascending oral doses of CYB003. In participants with MDD, the trial will also assess rapid onset of antidepressant effect on the day of dosing, using the Montgomery-Asberg Depression Rating Scale (“MADRS”) and evaluate the incremental benefit of a second dose of CYB003 when administered at Week 3. An optional period of assessment will help determine the durability of treatment effect out to 12 weeks. The study is listed on ClinicalTrials.gov under Identifier: NCT05385783.

About Cybin

Cybin is a clinical-stage biopharmaceutical company on a mission to create safe and effective psychedelic-based therapeutics to address the large unmet need for new and innovative treatment options for people who suffer from mental health conditions.

Cybin’s goal of revolutionizing mental healthcare is supported by a network of world-class partners and internationally recognized scientists aimed at progressing proprietary drug discovery platforms, innovative drug delivery systems, and novel formulation approaches and treatment regimens. The Company is currently developing CYB003, a proprietary deuterated psilocybin analog for the treatment of major depressive disorder and CYB004, a proprietary deuterated DMT molecule for generalized anxiety disorder and has a research pipeline of investigational psychedelic-based compounds.