Cybin Inc. announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for its Phase 1/2a first-in-human clinical trial evaluating CYB003, a proprietary deuterated psilocybin analog, for the treatment of major depressive disorder (MDD). About the CYB003 Phase 1/2a Trial: The Phase 1/2a trial is a randomized, double blind, placebo-controlled study evaluating people with moderate to severe MDD. Subjects will receive two administrations (placebo/active and active/active) and a response/remission will be assessed at Week 3 (after single dose) and at Week 6 (after receiving a second dose).

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 benefit of more than one administration and will provide pharmacokinetic (PK) and safety data. The trial design will allow for people to continue their treatment with selective serotonin reuptake inhibitors (SSRIs).

An optional open-label follow-up study (up to 12 weeks) will allow an assessment of durability of treatment effects. The Company has engaged Clinilabs Drug Development Corporation to carry out the Phase 1/2a clinical trial of CYB003.