Cybin Inc., a biopharmaceutical company focused on developing psychedelic-based treatments, announced its involvement in the upcoming Interdisciplinary Conference on Psychedelic Research (ICPR) scheduled for June 6-8, 2024, in Haarlem, Amsterdam. The company’s Chief Medical Officer, Dr. Amir Inamdar, and Director of Clinical Development, Dr. Ellen James, will be representing Cybin at the event.
Dr. Inamdar is slated to participate in two panel discussions. His first appearance will be at the Pathways to Access Summit (PATHS), a pre-ICPR event, on June 5, where he will discuss “Towards Marketing Approval of Psychedelics – Designing Trials and Engaging with Regulators” at 10:20 a.m. Central European Time. His second panel, “Pathways to Access in Europe,” will occur on June 8 at 2:20 p.m. Central European Time at the ICPR.
Dr. James is scheduled to present an abstract titled “
SPL026 (DMT fumarate) in combination with SSRIs for patients with
Major Depressive Disorder” on June 6 at 2:40 p.m. Central European Time. Her presentation will explore the results of an open-label study investigating the safety, tolerability, pharmacokinetics, pharmacodynamics, and exploratory efficacy of a single dose of SPL026 administered intravenously, either alone or in conjunction with SSRIs.
Dr. Inamdar expressed his enthusiasm about the opportunity to address the challenges and complexities involved in designing clinical trials for psychedelic treatments, as well as navigating the regulatory landscape in Europe. He emphasized the progress Cybin has made with its deuterated
psilocybin analog program (
CYB003) for
Major Depressive Disorder (MDD) and its deuterated dimethyltryptamine (DMT) molecule (
CYB004) for
Generalized Anxiety Disorder (GAD). With the U.S. Food and Drug Administration recently granting Breakthrough Therapy Designation for CYB003 and positive results emerging from Phase 2 trials, Cybin is preparing for a multinational Phase 3 trial. Dr. Inamdar underscored the significance of this moment given the increasing acceptance of psychedelics in mental healthcare.
Dr. James highlighted the importance of the ICPR as a platform for engaging with leading researchers in the field. She noted that while SSRIs are the predominant treatment for MDD, many recent studies involving psychedelics have excluded patients currently taking SSRIs. Her study’s findings suggest that patients can safely continue their antidepressants while undergoing psychedelic treatment, and that it may even be advantageous for them to remain on SSRIs.
Founded in 2019 and headquartered in Canada, Cybin aims to address the unmet needs in mental health by developing innovative, safe, and effective psychedelic-based therapeutics. The company collaborates with globally recognized scientists and partners to advance its drug discovery platforms, drug delivery systems, and treatment protocols. Cybin's current projects include CYB003 for MDD and CYB004 for GAD, alongside a pipeline of other investigational psychedelic-based compounds.
Cybin operates in several countries, including Canada, the United States, the United Kingdom, the Netherlands, and Ireland. The company remains committed to rigorous scientific research and clinical trials to validate the efficacy and safety of its proposed products. No product claims have been evaluated by regulatory authorities like the U.S. Food and Drug Administration or Health Canada.
As the psychedelics sector gains momentum, Cybin positions itself as a leader in the field, aspiring to enhance mental healthcare and provide new treatment avenues for those in need.
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