09:58:51 EDT Sun 23 Jun 2024
Enter Symbol
or Name

Cybin Inc
Symbol CYBN
Shares Issued 410,855,285
Close 2024-01-22 C$ 0.485
Market Cap C$ 199,264,813
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Cybin receives FDA OK to begin phase 2a CYB004 study

2024-01-23 09:05 ET - News Release

Mr. Doug Drysdale reports


The U.S. Food and Drug Administration (FDA) has cleared Cybin Inc.'s investigational new drug (IND) application for CYB004, its proprietary deuterated dimethyltryptamine (DMT) molecule in development for the treatment of generalized anxiety disorder (GAD). This clearance allows the company to proceed with its plans to initiate a phase 2a study of CYB004 in Q1 2024. The phase 2a study will be a randomized, double-blind, active-controlled trial to assess the preliminary clinical efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of CYB004 in participants with GAD. This trial will be conducted at study sites in the United States.

"With the recent positive top-line 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 Doug Drysdale, chief executive officer of Cybin. "From our extensive portfolio of DMT and deuterated DMT data sets 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. We look forward to exploring the potential of CYB004 to offer more convenient and patient-friendly dose forms and treatment duration," concluded Mr. Drysdale.

About generalized anxiety disorder

Anxiety disorders are the most prevalent mental health disorders globally, contributing to over 28 million disability-adjusted life years (DALYs). GAD is the most common anxiety disorder seen in primary care, with a 12-month prevalence of 2.9 per cent in the United States.

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 health care 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 analogue 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.

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