Cybin has completed dosing the final cohort in a Phase II study of CYB003 to treat moderate to severe major depressive disorder (MDD).
The Phase II portion is part of the placebo-controlled, double-blind, randomised Phase I/II study that is evaluating the tolerability, safety, pharmacodynamics, pharmacokinetics and psychedelic effect of ascending oral doses of the proprietary deuterated psilocybin analog CYB003 in both healthy volunteers and in MDD patients.
In the Phase I/II study, healthy volunteers received two administrations (placebo/active and active/active) one week apart, and the measures of psychedelic impact were evaluated following each dose.
Participants suffering with MDD received two administrations (placebo/active and active/active) three weeks apart and their response/remission were evaluated three weeks following each dose.
MDD participants in the study who are presently receiving antidepressants are allowed to continue their medication.
In these patients, the trial will also evaluate the rapid onset of antidepressant effects on the day of dosing, leveraging the Montgomery-Asberg Depression Rating Scale (MADRS), as well as assess the incremental benefit of a second dose of CYB003 administered at week three.
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An optional period of assessment will also help establish the durability of treatment effect up to 12 weeks.
Safety and tolerability of CYB003 were demonstrated in six cohorts who received 1mg, 3mg, 8mg, 10mg, 12mg and 16mg of this formulation.
No serious adverse events or discontinuations due to adverse events were observed in the final dose cohort.
Cybin CEO Doug Drysdale said: “With top-line efficacy data expected later this year, we are focusing on the upcoming data submission to the US Food and Drug Administration and readying ourselves to scale for a potential Phase III pivotal study early in 2024.
“We believe this a value inflection point for Cybin, as we continue to pursue our goal of improving the treatment landscape across mental health disorders.”
Cybin stated that its CYB003 programme is supported by a composition of matter patent, with protection through to 2041.