Cybin Inc.company committed to revolutionizing mental healthcare by developing new and innovative psychedelic-based treatment options, is pleased to announce that its Phase 2 trial evaluating CYB003, an investigational proprietary deuterated analog of psilocybin for the potential treatment of major depressive disorder (“MDD”), has completed dosing in Cohort 5 with no serious adverse events or other adverse events that may preclude continued dosing. The completed Cohorts 4 and 5 evaluated two 12mg doses of CYB003, and recruitment is underway to commence dosing for Cohort 6, the final cohort in the Phase 2 portion of the study.

“The completion of CYB003 dosing in Cohort 5 represents a significant milestone in the progression of our Phase 2 study, taking us one step closer towards establishing a therapeutically efficacious dose and advancing CYB003 towards pivotal studies with the goal of bringing CYB003 as a differentiated and rapid-acting therapeutic option for people with major depressive disorder,” said Doug Drysdale, Chief Executive Officer of Cybin. “We are proud of the speed with which we have advanced our clinical-stage programs and remain on track to deliver topline efficacy data from this Phase 2 study later this year and submit data to the FDA in preparation for a potential pivotal study of CYB003.”

To date, CYB003 has demonstrated a favorable safety and tolerability profile with no serious adverse events reported at the doses evaluated (1mg, 3mg, 8mg, 10mg, and 12 mg). Interim findings from the Phase 1/2a study have also demonstrated positive observations, showing that CYB003 dosing led to a rapid and robust psychedelic response in participants at low doses, while maintaining a safe and well-tolerated therapeutic profile.

Upcoming milestones for the CYB003 program:

Completion of CYB003 dosing in MDD cohorts expected in Q3 2023
Topline efficacy data readout from CYB003 Phase 2 clinical trial expected in Q3/Q4 2023
U.S. Food and Drug Administration (“FDA”) submission of CYB003 Phase 1/2a data for pivotal studies expected following topline efficacy data readout

 

Source:businesswire.com/

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