Cybin has confirmed it has received approval for its Phase 1/2a trial evaluating its proprietary deuterated psilocybin analogue for the treatment of Major Depressive Disorder (MDD).
With a focus on progressing “psychedelics to therapeutics”, biopharmaceutical company Cybin has received Institutional Review Board (IRB) approval for the trial.
It will be a first-in-human Phase 1/2a clinical trial evaluating psilocybin analogue CYB003 derived from psilocybin. CYB003 is designed to achieve less variability in plasma levels, faster onset of action, shorter duration of effect and potentially better tolerability for an overall better outcome for patients.
Cybin states that CYB003 has the potential to effectively treat major depressive disorder and Alcohol Use Disorder.
Cybin CEO, Doug Drysdale, stated: “IRB approval of our trial protocol is a significant regulatory milestone for CYB003 as it leads us one step closer to potentially providing this important treatment option to people in need.
“The team has worked tirelessly to move this programme into the clinic, and we look forward to initiating the study in mid-2022 and further supporting our mission to develop psychedelics into therapeutics.”
The trial is a randomised, doubleblind, placebo-controlled study evaluating people with moderate to severe MDD.
Participants in the trial will receive two administrations (placebo/active and active/active) and a response/remission will be assessed in the third week after single dose and in the sixth week after receiving a second dose.
Using the Montgomery-Asberg Depression Rating Scale, it 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 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.
Cybin submitted an Investigational New Drug application to the US Food and Drug Administration (FDA) in May for the trial, and wholly owned subsidiary of Cybin, Cybin IRL Limited, has engaged Clinilabs Drug Development Corporation, a global, full-service contract research organisation with deep expertise in central nervous system drug development, to carry out the Phase 1/2a clinical trial of CYB003.
[activecampaign form=52]
