TORONTO, May 29, 2024–(BUSINESS WIRE)–Cybin Inc. (NYSE American:CYBN) (Cboe CA:CYBN) (“Cybin” or the “Company“), a clinical-stage biopharmaceutical company committed to revolutionizing mental healthcare by developing new and innovative next-generation psychedelic-based treatment options, today announced that Amir Inamdar, MBBS, DNB (Psych), MFPM, Cybin’s Chief Medical Officer, and Ellen James, Ph.D., Cybin’s Director, Clinical Development, will participate at the Interdisciplinary Conference on Psychedelic Research (“ICPR”) taking place June 6-8, 2024, in Haarlem, Amsterdam.
Dr. Inamdar will speak at the following two panels:
- “Towards Marketing Approval of Psychedelics – Designing Trials and Engaging with Regulators” at the Pathways to Access Summit (PATHS), a pre-ICPR event, on Wednesday, June 5 at 10:20 a.m. Central European Time.
- “Pathways to access in Europe” at ICPR on Saturday, June 8 at 2:20 p.m. Central European Time.
“I look forward to discussing some of the critical issues and key challenges unique to clinical trial design for psychedelic treatments, and pathways to marketing authorization in Europe,” stated Amir Inamdar, Cybin’s Chief Medical Officer. “I am eager to learn from leaders in the scientific community and to share the significant progress that Cybin has made across CYB003, our deuterated psilocybin analog program for the treatment of Major Depressive Disorder (“MDD”), and CYB004, our proprietary deuterated dimethyltryptamine (“DMT”) molecule in development for the treatment of Generalized Anxiety Disorder (“GAD”). With the U.S. Food and Drug Administration’s recent Breakthrough Therapy Designation for CYB003, and positive data in hand from our recently completed Phase 2 trial, we are nearing the start of our multinational, multisite Phase 3 program for CYB003. This, coupled with the growing attention and acceptance of the psychedelics sector as a whole, presents an opportune time to discuss the regulatory and commercial path forward for psychedelics and to share key learnings from our early clinical studies. Cybin is pleased to be a leader in bringing improved treatments to address the urgent needs in mental healthcare,” concluded Dr. Inamdar.
“The ICPR is an important forum for engagement with top researchers in the field, and I am grateful for the opportunity to present data from our study of SPL026 (DMT fumarate) in combination with SSRIs for patients with MDD,” said Ellen James, Cybin’s Director, Clinical Development. “While selective serotonin reuptake inhibitors (“SSRIs”) are the dominant treatment for MDD, recent studies with psychedelics have most often been conducted with patients not currently taking SSRIs. Our open-label study investigated the safety, tolerability, pharmacokinetics, pharmacodynamics and exploratory efficacy of a single SPL026 intravenous dose, alone or in combination with SSRIs. The results suggest that patients can safely continue using their antidepressants while undergoing psychedelic treatment and, in fact, that it may be beneficial for patients to remain on their ongoing SSRIs,” concluded Dr. James.
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.