FDA Approves Cybin's Phase 2a Trial for CYB004 in GAD

Cybin Inc., a biopharmaceutical company focused on developing psychedelic treatments for mental health conditions, has received a green light from the U.S. Food and Drug Administration (FDA) to advance its drug candidate CYB004 into a Phase 2a clinical trial. The drug, a proprietary form of deuterated dimethyltryptamine (DMT), is being studied for its potential to treat Generalized Anxiety Disorder (GAD). The FDA's clearance follows positive initial studies which indicated that intravenous CYB004 showed significant and rapid psychedelic effects at doses lower than those of the native DMT.

Cybin's upcoming Phase 2a study, set to begin in the first quarter of 2024, will be a randomized, double-blind, active-controlled trial. It aims to evaluate the preliminary clinical efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of CYB004 in individuals suffering from GAD. The trial will take place at various study sites across the United States.

Doug Drysdale, Cybin's Chief Executive Officer, expressed optimism about the Phase 2a study, citing positive results from previous Phase 1 studies of the company's deuterated DMT molecules. He highlighted the importance of these insights for guiding future research and development efforts, particularly in relation to dosing and efficacy in treating both depression and anxiety.

Anxiety disorders are recognized as the most common mental health disorders globally, with GAD being the most prevalent in primary care settings. In the United States, GAD affects nearly 3% of the population over a 12-month period. Current treatments for anxiety disorders have limited effectiveness, and there is a significant need for improved therapeutic options.

Cybin is dedicated to creating innovative and effective treatments to enhance the quality of life for those living with mental health disorders. The company's mission is supported by a network of esteemed partners and scientists working on drug discovery platforms, drug delivery systems, and novel treatment approaches.

Cybin is also developing other psychedelic-based therapeutics, including CYB003, a deuterated psilocybin analog for major depressive disorder, and has a pipeline of investigational compounds for various mental health conditions. The company, founded in 2019 and headquartered in Canada, operates in several countries including the United States, the United Kingdom, the Netherlands, and Ireland.