Cybin Inc, a biopharmaceutical company focused on progressing effective therapeutics for patients, is submitting an Investigational New Drug application to the U.S. Food and Drug Administration 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).
The Phase 1/2a trial is a randomized, double blind, placebo-controlled study that assesses people with moderate to severe MDD. Subjects receive two administrations (placebo/active and active/active) and a response/remission assessed at Week 3 (after single dose) and at Week 6 (after receiving a second dose). The Montgomery-Asberg Depression Rating Scale is used in the trial to assess rapid onset of antidepressant effect on the day of dosing. The study also evaluates the benefit of more than one administration and provides pharmacokinetic and safety data. The trial design allows people to continue their treatment with selective serotonin reuptake inhibitors. An optional open-label follow-up study (up to 12 weeks) grants an assessment of durability of treatment effects.
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