–Phase 2 topline efficacy data for CYB003 on track for Q4 2023, followed by U.S. Food and Drug Administration (“FDA”) submission of CYB003 Phase 1/2 data for pivotal studies –
– Breakthrough Therapy designation anticipated in late 2023, subject to FDA approval –
– Previously announced acquisition of Small Pharma Inc. expected to close in Q4 2023, creating an international clinical-stage leader in novel psychedelic therapeutics –
– Multinational operations support potential scaling to Phase 3 development of CYB003 in early 2024 –
Cybin Inc. (NYSE American: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.
“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 program.”
-Doug Drysdale, Chief Executive Officer of Cybin.
“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.
About the Phase 1/2 CYB003 Trial
The Phase 1/2 trial is a randomized, double-blind, placebo-controlled study evaluating CYB003 in participants with moderate to severe MDD and in healthy volunteers. Healthy volunteers receive two administrations (placebo/active and active/active) one week apart, and measures of psychedelic effect are assessed after each dose. Participants with MDD receive two administrations (placebo/active and active/active) three weeks apart and response/remission are assessed three weeks after each dose. MDD participants in the trial that are currently being treated with antidepressants are allowed to remain on their antidepressant medication.
The study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics, and psychedelic effect of ascending oral doses of CYB003. In participants with MDD, the trial will also assess rapid onset of antidepressant effect on the day of dosing, using the Montgomery-Asberg Depression Rating Scale (“MADRS”) and evaluate the incremental benefit of a second dose of CYB003 when administered at Week 3. An optional period of assessment will help determine the durability of treatment effect out to 12 weeks. The study is listed on ClinicalTrials.gov under Identifier: NCT05385783.
Cybin is a clinical-stage biopharmaceutical company on a mission to create safe and effective psychedelic-based therapeutics to address the large unmet need for new and innovative treatment options for people who suffer from mental health conditions.
Cybin’s goal of revolutionizing mental healthcare is supported by a network of world-class partners and internationally recognized scientists aimed at progressing proprietary drug discovery platforms, innovative drug delivery systems, and novel formulation approaches and treatment regimens. The Company is currently developing CYB003, a proprietary deuterated psilocybin analog for the treatment of major depressive disorder and CYB004, a proprietary deuterated DMT molecule for generalized anxiety disorder and has a research pipeline of investigational psychedelic-based compounds.
Headquartered in Canada and founded in 2019, Cybin is operational in Canada, the United States, the United Kingdom, the Netherlands and Ireland. For company updates and to learn more about Cybin, visit www.cybin.com or follow the team on X, LinkedIn, YouTube and Instagram.