Cybin Inc. and its partner Clinilabs Drug Development Corporation have been granted a Schedule I license to support the first-in-human Phase 1/2a clinical trial of CYB003 by the US Drug Enforcement Agency (DEA).
CYB003 is a proprietary deuterated psilocybin analog that is being developed for the treatment of major depressive disorder (MDD). The DEA license is a federal requirement for any investigators who intend to study, produce, analyse, or otherwise work with Schedule I controlled substances.
The Phase 1/2a trial is a randomised, double-blind, placebo-controlled study evaluating people with moderate to severe MDD.
Participants will receive two administrations (placebo/active and active/active) and a response/remission will be assessed at week three (after first dose) and at week six (after second dose). Importantly, participants in the trial that are currently being treated with antidepressants will be allowed to remain on their antidepressant medication.
Cybin CEO, Doug Drysdale, commented: “Obtaining a DEA license for our Phase 1/2a trial is the final step clearing the way to begin dosing participants in our first-in-human study of CYB003. Our rigorous recruitment and enrollment process is well under way, and we are excited to commence dosing of our first cohort of participants.”
Using the Montgomery-Asberg Depression Rating Scale, the trial will assess rapid onset of antidepressant effect on the day of dosing. The study will also evaluate the incremental benefit of a second dose of CYB003 when administered at week three and will provide important PK and safety data to determine a clinical path forward.
An optional period of assessment will help determine the durability of treatment effect out to 12 weeks.
This research study is recruiting individuals between the ages of 21 and 55 who have been diagnosed with MDD and who are currently taking an antidepressant medication that is not working to their satisfaction.
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