Cybin Inc. has announced the completion of enrollment into its Phase 2 study investigating CYB003 – a proprietary deuterated psilocybin analogue – for the treatment of Major Depressive Disorder (MDD).
Cybin has confirmed that all participants in the final cohort have now received at least one dose of a placebo or 16mg of CYB003, with several second doses already administered.
No serious adverse events observed in participants so far.
To date, CYB003 has demonstrated a favourable safety and tolerability profile at all doses evaluated in the five completed cohorts of the study, at 1mg, 3mg, 8mg, 10mg, and 12mg.
Doug Drysdale, Chief Executive Officer of Cybin, stated: “The completion of enrollment in our Phase 2 CYB003 study is a significant milestone for Cybin that brings us closer than ever to understanding the potential antidepressant effects and clinical advantages of CYB003. We look forward to reporting topline efficacy results later this year, which will inform our plans for upcoming pivotal studies.
“Additionally, we have made substantial progress in preparing to scale to a multinational Phase 3 trial of CYB003 early next year and were recently granted a composition of matter patent further securing intellectual property protection for this important programme.”
Cybin has now initiated plans to scale the CYB003 programme to a potential Phase 3 study in early 2024, including a streamlined EMBARKCT facilitator training programme, partnering with a global contract research organisation, and preparing for Good Manufacturing Practice production of CYB003 capsules.
Cybin’s CYB003 programme 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.
“Looking ahead, we expect to close our acquisition of Small Pharma Inc. in Q4 2023, forming the most robust intellectual property portfolio in the sector and enhancing the combined company’s capabilities to bring these novel therapeutics through clinical development and to people in need,” concluded Drysdale.
