HomeMarket NewsMicro Cap StocksCybin Successfully Completes Dosing in Phase 2 Study of CYB003 for Major...

Cybin Successfully Completes Dosing in Phase 2 Study of CYB003 for Major Depressive Disorder Treatment

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Cybin Inc. (NYSE: CYBN), a clinical-stage biotech company specializing in the development of innovative psychedelic-based mental health treatments, has reached a significant milestone by completing the dosing phase of its Phase 2 study on CYB003, a deuterated psilocybin analog being evaluated for the treatment of Major Depressive Disorder (MDD).

This crucial phase of the CYB003 program, which is protected by a composition of matter patent until 2041, is expected to provide top-line efficacy data before the end of the year.

Doug Drysdale, the CEO of Cybin, expressed excitement over the rapid progression of the entire trial, from dosing initiation to completion across all participant cohorts. With the dosing phase complete, Cybin will shift its focus to submitting the data to the FDA in preparation for a potential scaling to a Phase 3 pivotal study in early 2024, which represents a significant value inflection point for the company.

In preparation for the Phase 3 trial, Cybin plans to begin dosing with a novel, stable, and dose-flexible capsule formulation produced under Good Manufacturing Practice (GMP), develop a scalable version of the facilitator training program EMBARK, and partner with Worldwide Clinical Trials.

Trial Details

The Phase 1/2 study examines the safety, tolerability, pharmacokinetics and pharmacodynamics, and psychedelic effect of CYB003 in ascending oral doses in both individuals with moderate-to-severe MDD and healthy volunteers.

Healthy volunteers received two administrations, one week apart, consisting of placebo/active and active/active doses, with measures of psychedelic effect assessed after each dose.

Participants with MDD received two administrations, three weeks apart, consisting of placebo/active and active/active doses. The study assessed response and remission three weeks after each dose, as well as the rapid onset of the antidepressant effect on the dosing day and the incremental benefit of a second dose administered at week 3.

An optional assessment period will measure the durability of the treatment’s effect for up to 12 weeks.

Throughout the six cohorts, CYB003 doses ranging from 1mg to 16mg have been shown to be safe and well-tolerated, with no serious adverse events or discontinuations due to adverse events observed in the final (and highest) dose cohort.

Photo: Benzinga edit with photo by Olia Danilevich on Pexels.

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