Cybin Inc. (CYBN), a biopharmaceutical company focused on progressing “Psychedelics to Therapeutics," has submitted an Investigational New Drug (or “IND”) application to the FDA. The aim is to begin the first phase (1/2a) of what would be the first human clinical trials to evaluate the effects of the company’s new compound called CYB003, a proprietary deuterated psilocybin analog on major depressive disorder (MDD).
CYB003 received FDA approval just last month and is now waiting to test efficacy and safety on the first group of people within the study.
Cybin CEO Doug Drysdale stated, “Based on preclinical studies, our proprietary psilocybin analog has the potential to offer numerous advantages over classic psilocybin with the potential to ultimately provide better outcomes for people suffering with MDD.”
The trial phase 1/2a is expected to be achieved by mid-2022. Carried out by Clinilabs Drug Development Corporation, a global, full-service contract research organization with expertise in central nervous system drug development, it will be 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 a single dose) and at Week 6 (after receiving a second dose).
Using the Montgomery-Asberg Depression Rating Scale, the trial will assess the 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 and safety data.
The trial design will allow for people to continue their treatment with selective serotonin reuptake inhibitors (or antidepressants). An optional open-label follow-up study (up to 12 weeks) will allow an assessment of the durability of treatment effects.
Photo Courtesy of Joshua Earle on Unsplash.
