Clinilabs Drug Development Corporation has begun enrolment in a Phase 1/2a clinical trial of Cybin’s CYB003 for the treatment of major depressive disorder (MDD).
CYB003 is being developed by Cybin Inc.. It is a deuterated analogue of psilocybin designed to potentially address the challenges and limitations of oral psilocybin.
To date, based on preclinical data, CYB003 has achieved less variability in plasma levels, faster onset of action, and shorter duration of effect, and Cybin believes the compound has the potential to reduce time and resource burden on patients, providers, and payers, and possibly improve scalability and accessibility of treatment.
In June, Cybin announced that it received Investigational New Drug (IND) clearance from the US Food and Drug Administration for the Phase 1/2a trial.
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 of the study drug and a response/remission will be assessed at week three after the first dose and at week six after second dose.
Participants in the trial that are currently being treated with selective serotonin reuptake inhibitors (SSRIs) will be allowed to remain on their antidepressant medication.
In April, Cybin partnered with Clinilabs Drug Development Corporation, which is a global, full-service contract research organisation with expertise in central nervous system drug development, to carry out the trial.
Vice president of strategy and corporate development at Clinilabs, Jeanine Falinski, commented: “Clinilabs is honored to be working with Cybin, an innovator in the development of novel psychedelic therapeutics, to conduct its first-in-human clinical trial of CYB003.
“We are excited by the potential of these therapeutics and hope that the future is life-changing for individuals suffering from mental illness. We are encouraged by the interest from potential research participants who have already come forward prior to today.”
CEOof Cybin, Doug Drysdale, commented: “Successful patient recruitment and a proper clinical environment are integral components of this trial.
“As a global leader in drug development services, Clinilabs is a perfect partner and we are thankful for their support and guidance.”
The trial will use the Montgomery-Asberg Depression Rating Scale to assess rapid onset of antidepressant effect on the day of dosing, and will evaluate the incremental benefit of a second dose of CYB003 when administered at week three.
It will provide important pharmacokinetic and safety data to determine a clinical path and an optional period of assessment will help determine the durability of treatment effect out to 12 weeks.
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