Cybin Outlines Upcoming Priorities and Milestones for its Clinical Development Programs

Cybin, a biopharmaceutical company focused on progressing Psychedelics to Therapeutics outlined its upcoming priorities and near-term milestones that support the development of its CYB003 and CYB004 clinical programs aimed at addressing multiple mental health conditions.

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“Cybin enters 2023 with the potential to reach a number of value-driving milestones, including important advancements across our development pipeline,” said Doug Drysdale, Chief Executive Officer of Cybin. “These priorities will provide important information to help strengthen our business as we continue to focus on the progression of our innovative investigational therapies aimed at addressing the significant unmet need for people struggling with mental health conditions.”

CYB003 for the Treatment of Major Depressive Disorder (“MDD”)

Cybin is currently conducting a Phase 1/2a clinical trial evaluating CYB003, a deuterated psilocybin analog, in people suffering from MDD. The Company today announced that it plans to provide an interim readout from the Phase 1/2a trial by the end of February 2023. The interim readout is intended to provide an initial understanding of the safety and pharmacokinetic (“PK”) profile of CYB003 in humans, including preliminary observations related to the psychedelic effect and duration of psychedelic effect of CYB003. These findings will help provide the necessary dose ranging information for the ongoing Phase 1/2a trial in addition to future clinical studies evaluating CYB003.

CYB003 is designed to potentially address the challenges and limitations of oral psilocybin. Based on preclinical data, CYB003 achieved less variability in plasma levels, faster onset of action, and shorter duration of effect. CYB003’s therapeutic profile as a differentiated treatment for MDD is expected to provide more consistent and predictable dosing, and reduced intra- and inter- individual variability, ultimately resulting in reduced time and resource burden on the healthcare system.

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CYB003 is the first ever deuterated psilocybin analog to enter clinical development.

CYB004 for the Treatment of Anxiety Disorders

Cybin is currently conducting a Phase 1 exploratory trial (“CYB004-E trial”) evaluating IV N,N-dimethyltryptamine (“DMT”) to yield essential safety and dosing optimization data for the future clinical development of CYB004 (deuterated DMT) for the treatment of anxiety disorders. To date, the CYB004-E trial has not demonstrated any clinically significant safety or tolerability issues. Cybin expects to translate key learnings from the initial study, including dose optimization and dosing dynamics, to support the remaining planned cohorts. These learnings are also expected to accelerate Cybin’s plans to commence dosing of CYB004 in humans. The Company plans to provide an update on its CYB004 program by the end of February 2023.

In its natural form DMT is rapidly metabolized in the body and is not orally bioavailable. Based on preclinical studies, CYB004, a new chemical entity, has the potential to overcome the limitations of DMT. Specifically, these data showed that CYB004 had increased oral and pulmonary bioavailability, faster onset with lower doses, lower inter-subject variability, and better dose titration for fewer side effects compared with oral and IV DMT.

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