Cybin Inc. (NYSE:CYBN) (NEO:CYBN) (“Cybin” or the “Company“), a clinical-stage biopharmaceutical company committed to revolutionizing mental healthcare by developing new and innovative psychedelic-based treatment options, is pleased to announce that it has completed enrollment in its Phase 2 study of CYB003, a proprietary deuterated psilocybin analog program being developed for the potential treatment of major depressive disorder (“MDD”). All participants in the final cohort have received at least one dose (placebo or 16mg of CYB003) with several second doses already administered, and no serious adverse events observed in participants. To date, CYB003 has demonstrated a favorable safety and tolerability profile at all doses evaluated in the five completed cohorts (1mg, 3mg, 8mg, 10mg, and 12mg). The Company expects to complete dosing the final cohort in early Q4 2023.
The Company has initiated plans to scale the CYB003 program to a potential Phase 3 study in early 2024, including a streamlined EMBARKCT facilitator training program, partnering with a global contract research organization, and preparing for Good Manufacturing Practice (“GMP”) production of CYB003 capsules. The CYB003 program is supported by a recently granted U.S. patent covering composition of matter claims until 2041. Further, the Company anticipates potential Breakthrough Therapy designation, subject to FDA approval, in Q4 2023
