Cybin Inc. (NYSE American:CYBN) (Cboe CA:CYBN) (“Cybin” or the “Company”), a clinical-stage breakthrough neuropsychiatry company committed to revolutionizing mental healthcare by developing new and innovative next-generation treatment options, today announced the presentation of two posters at the American College of Neuropsychopharmacology (“ACNP”) Annual Meeting taking place December 8-11, 2024, in Phoenix, Arizona.
The data presented include 12-month efficacy results from the Company’s Phase 2 study of CYB003, its deuterated psilocin program, in Major Depressive Disorder (“MDD”), which showed durable response and remission rates at 12 months, in addition to results from a completed Phase 1b study exploring drug-drug interactions between N,N-dimethyltryptamine (“DMT”) and selective serotonin reuptake inhibitors (“SSRIs”), in MDD patients.
“The ACNP annual meeting is an excellent opportunity to share the rapid clinical progress Cybin is making across our deuterated psilocin and DMT programs,” said Doug Drysdale, Chief Executive Officer of Cybin. “MDD affects roughly 21 million people in the U.S., alone, yet roughly two thirds do not experience relief from traditional antidepressant treatments. Developing new and improved treatments for MDD sufferers is a top priority for us. We look forward to engaging with the internationally distinguished researchers and scientists who share our passion to bring innovative therapeutics to the mental health space. With the recent initiation of our Phase 3 PARADIGM program evaluating CYB003 in MDD, this is a pivotal time for Cybin,” concluded Drysdale
“The sustained improvement in symptoms of depression at the 12-month mark after just two doses of CYB003 is truly outstanding and a testament to its potential as a transformative treatment that can change the treatment paradigm for patients suffering from depression,” said Amir Inamdar, MBBS, DNB (Psych), FFPM, Chief Medical Officer of Cybin. “In our Phase 2 study of CYB003 in MDD, we reported remarkable efficacy results at 12 months, showing a 100% response rate and 71% remission rate among participants who received two 16 mg doses of CYB003. In addition, results from our study evaluating SPL026 (DMT fumarate) in combination with SSRIs for patients with MDD imply that participants do not need to titrate off their antidepressant treatment in order to undergo psychedelic treatment. The findings also suggest a potentially enhanced efficacy effect when SPL026 was administered with SSRIs. The ACNP conference provides an ideal setting to share this compelling work with leading experts in the mental health sector.”
“In addition to our CYB003 program, Cybin is advancing our deuterated DMT program, CYB004, which is currently in a Phase 2 Generalized Anxiety Disorder (“GAD”) study,” said Geoff Varty, Ph.D., Senior Vice President of Research & Preclinical Development. “The data presented at this conference are foundational to our CYB004 program, as it provides proof-of-concept for deuterated DMT’s potential in the treatment of GAD.”
- Title: CYB003 Produces Robust and Enduring Antidepressant Effects in Patients with Major Depressive Disorder (MDD)
- Authors: Amir Inamdar, Sebastian Krempien, Alex Kelman, Atul Mahableshwarkar, Magdy Shenouda, Kimball Johnson, Saundra Ann Maass-Robinson, Pradip Pathare, Allison House-Gecewicz, Angela Sorie, Aaron Bartlone, Geoffrey Varty
- Poster Number: M77
- Title: SPL026 (DMT fumarate) in combination with Selective Serotonin Reuptake Inhibitors (SSRIs) for patients with Major Depressive Disorder
- Authors: Ellen H. James, Zelah Joel, Victoria Attwooll, Tiffanie A. Benway, Meghan H. Good, George Tziras, Carol Routledge, Thomas A. Macek
- Poster Number: M59
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 analog, in Phase 3 studies for the adjunctive treatment of Major Depressive Disorder and CYB004, a proprietary deuterated N,N-dimethyltryptamine molecule 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.