New York, January 24, 2024 - PrismMarketView - Cybin Inc. (NYSE American: CYBN) has been granted FDA clearance for its investigational new drug (IND) application for CYB004, its proprietary deuterated dimethyltryptamine (DMT) molecule in development for the treatment of Generalized Anxiety Disorder (GAD). The company plans to initiate a Phase 2a study of CYB004 in Q1 2024. Cybin topped the PRISM Emerging Psychedelics Index with the highest volume at midday on Wednesday.
“Although anxiety disorders are one of the most prevalent mental health disorders, current treatment options remain limited, with suboptimal response and remission rates. We are committed to developing improved treatment options with the goal of improving the quality of life for people suffering from anxiety disorders worldwide. We look forward to exploring the potential of CYB004 to offer more convenient and patient-friendly dose forms and treatment duration.”
Doug Drysdale, Chief Executive Officer of Cybin
Highlights
Cybin’s Phase 2a study will be a randomized, double-blind, active-controlled trial to assess the preliminary clinical efficacy, safety, tolerability, PK and PD of CYB004 in participants with GAD. This trial will be conducted at study sites in the United States.
The company recently released positive topline results from two Phase 1 studies of its proprietary deuterated DMT molecules, CYB004 and SPL028. Cybin has completed five clinical studies in total, allowing it to gather important insights on dosing and preliminary efficacy signals in both depression and anxiety.
Anxiety disorders are the most prevalent mental health disorders globally, and GAD is the most common anxiety disorder seen in primary care in the United States.
About Cybin
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.
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