–Topline efficacy data expected in Q4 2023 –
– Preparations are underway to scale the CYB003 program to a potential Phase 3 study in early 2024 –
Cybin Inc. (NYSE American:CYBN) (NEO:CYBN) (“Cybin” or the “Company”), a clinical-stage biopharmaceutical company committed to revolutionizing mental healthcare by developing new and innovative psychedelic-based treatment options, today announced the completion of dosing of the final cohort in its Phase 2 study of CYB003, a proprietary deuterated psilocybin analog program in development for the potential treatment of major depressive disorder (“MDD”). The CYB003 program is supported by a composition of matter patent with protection through 2041. The Company expects to release topline efficacy data in the fourth quarter of this year.
“We are extremely pleased with the rapid progression we have made from initiation to completion of dosing across all cohorts in our Phase 2 CYB003 MDD study. With topline efficacy data expected later this year, we are focusing on the upcoming data submission to the U.S. Food and Drug Administration (“FDA”) and readying ourselves to scale for a potential Phase 3 pivotal study early in 2024. We believe this a value inflection point for Cybin, as we continue to pursue our goal of improving the treatment landscape across mental health disorders.”
-Doug Drysdale, Chief Executive Officer of Cybin
The following doses were evaluated in the six cohorts: 1mg, 3mg, 8mg, 10mg, 12mg, and 16mg. To date, CYB003 has been shown to be safe and tolerable at all doses evaluated with no serious adverse events or discontinuations due to adverse events having been observed in the final dose cohort.
Cybin’s preparation for the next stage of development include:
- Commencement of dosing with capsule formulation in the bio equivalence cohort to enable more convenient dosing in Phase 3;
- End of Phase 2 meeting expected in Q1 2024, to review the Phase 3 study design;
- Developing EMBARK for Clinical Trials (“EMBARKCT”) as a scalable model of psychedelic facilitation training to support future pivotal studies;
- Partnering with Worldwide Clinical Trials, a global, full-service contract research organization with a successful track record managing clinical trials for mental health conditions, including MDD; and
- Initiating preparations for good manufacturing practices (“GMP”) production of a capsule formulation of CYB003 – a robust solid dosage capsule form designed to be stable, dose flexible, patient-friendly, and commercially scalable, to be evaluated in a potential Phase 3 trial.
About the Phase 1/2 CYB003 Trial
The Phase 1/2 trial is a randomized, double-blind, placebo-controlled study evaluating CYB003 in participants with moderate to severe MDD and in healthy volunteers. Healthy volunteers received two administrations (placebo/active and active/active) one week apart, and measures of psychedelic effect are assessed after each dose. Participants with MDD received 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 are allowed to remain on their antidepressant medication.
The study is evaluating 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.
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.