TORONTO–(BUSINESS WIRE)–Cybin Inc. (NYSE American:CYBN) (Cboe CA:CYBN) (“Cybin” or the “Company”), a clinical-stage breakthrough neuropsychiatry platform company committed to revolutionizing mental healthcare by developing new and innovative next-generation treatment options, today announced additional strategic partnership agreements (“SPAs”), bringing the total to 18 clinical sites engaged to advance Cybin’s multinational Phase 3 program evaluating CYB003 for the adjunctive treatment of MDD. The APPROACH study is expected to include approximately 45 clinical sites.
“This SPA model serves to take advantage of the deep expertise of each individual site and ensure that protocols and best practices are shared consistently,” said Doug Drysdale, Chief Executive Officer of Cybin. “This level of cooperation will streamline trial operations and has the potential to reduce time to completion. We are especially pleased that Kimball A. Johnson, M.D., Medical Director of CenExel iResearch Atlanta, who served as the principal investigator for our successful Phase 1/2a CYB003 trial, and Paul Thielking, Chief Scientific Officer, Cedar Clinical Research, are participating in the SPA program. Our SPA partners are experienced in neuropsychiatric drug trials and share Cybin’s deep commitment to the highest quality standards of investigational clinical work, and to developing safe and effective next-generation treatments to improve patient outcomes.”
“I am delighted that iResearch Atlanta is participating in this next exciting stage of development for CYB003, and that we will be part of a consortium of sites working to advance its Phase 3 program,” said Kimball A. Johnson, M.D., Medical Director of CenExel iResearch Atlanta.
“Cedar Clinical Research has extensive experience in this space, and we are eager to join the other sites supporting Cybin’s PARADIGM program and address the global crisis in mental health,” said Paul Thielking, Chief Scientific Officer, Cedar Clinical Research, a Numinus Wellness Inc. company.
Cybin initiated the SPA program earlier this year with Segal Trials, a leading clinical research network located in South Florida. Each of the 18 U.S.-based SPA sites bring decades of clinical experience and a commitment to excellence to support and expedite the Company’s Phase 3 PARADIGM program.
Cybin is a late-stage breakthrough neuropsychiatry company committed to revolutionizing mental healthcare by developing new and innovative next-generation treatment options to address the large unmet need for people who suffer from mental health conditions.
With industry leading proof-of-concept data, Cybin is working to change the mental health treatment landscape through the introduction of intermittent treatments that provide long lasting results. The Company is currently developing CYB003, a proprietary deuterated psilocin program, in Phase 3 development for the adjunctive treatment of major depressive disorder and CYB004, a proprietary deuterated N, N-dimethyltryptamine program in a Phase 2 study for generalized anxiety disorder. The company also has a research pipeline of investigational, 5-HT-receptor focused compounds.
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.