Cybin (NEO: CYBN) (NYSE American: CYBN), a clinical-stage biopharmaceutical company committed to revolutionizing mental healthcare by developing new and innovative psychedelic-based treatment options, has received approval from the U.S. Food and Drug Administration (“FDA”) for its investigational new drug (“IND”) application for its proprietary deuterated dimethyltryptamine (“DMT”) molecule: CYB004. The clearance means that Cybin can move forward with plans to initiate a phase 2a study of CYB004 designed to evaluate the preliminary clinical efficacy, safety and tolerability of CYB004 for the treatment of Generalized Anxiety Disorder (“GAD”). The company is planning to initiate the study in the first quarter of 2024 at study sites in the United States. According to the announcement, Cybin recently announced positive phase 1 topline safety, pharmacokinetic (“PK”) and pharmacodynamic (“PD”) data indicating that intravenous (“IV”) CYB004 showed robust and rapid-onset psychedelic effects at lower doses compared to native DMT.
“With the recent positive topline results from two phase 1 studies of our proprietary deuterated DMT molecules, CYB004 and SPL028, we are well-positioned to initiate a phase 2a study of CYB004 in GAD this quarter,” said Cybin CEO Doug Drysdale in the press release. “From our extensive portfolio of DMT and deuterated DMT datasets across five completed clinical studies, we have gathered important insights on dosing and preliminary efficacy signals in both depression and anxiety that will inform our next steps. Exploratory data from our completed phase 2a study of SPL026 (‘IV DMT’) have shown that SPL026 reduced symptoms of anxiety in patients with major depressive disorder, which further serves to derisk the development of deuterated DMT in anxiety disorders as we continue to evaluate the efficacy and safety of CYB004. 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.”
To view the full press release, visit https://ibn.fm/EO7sJ
About Cybin Inc.
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; the company also 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 more information, visit the company’s website at www.Cybin.com.
NOTE TO INVESTORS: The latest news and updates relating to CYBN are available in the company’s newsroom at https://ibn.fm/CYBN
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