Phase 2 GAD Study for CYB004 Launched by Cybin

Cybin Inc., a biopharmaceutical company at the forefront of mental health innovation, has embarked on a groundbreaking journey to develop next-generation treatments using psychedelic compounds. The company's focus is on creating therapies that are not only effective but also scalable and time-efficient, with the potential to significantly reduce the disability-adjusted life years associated with anxiety disorders.

In a recent announcement, Cybin revealed the initiation of a Phase 2 study for CYB004, its proprietary deuterated dimethyltryptamine (DMT) molecule, specifically designed to treat Generalized Anxiety Disorder (GAD). This study follows the FDA's clearance of Cybin's Investigational New Drug application for CYB004, marking a significant milestone in the development of this novel treatment.

The Phase 2 study is set to be a randomized, double-blind trial, aiming to assess the safety and efficacy of CYB004 in participants suffering from GAD. The trial is expected to recruit approximately 36 participants, who will be divided into two groups, one receiving CYB004 and the other a low-dose control. The primary goal is to measure the change in anxiety levels using the Hamilton Anxiety Rating Scale after the second dose, with additional assessments focusing on depression, safety, and quality of life.

Cybin's approach to GAD is particularly noteworthy given the disorder's prevalence and the significant unmet medical need. Anxiety disorders impact over 40 million adults in the United States annually, with GAD being the most commonly diagnosed anxiety disorder in primary care settings. Despite existing treatments, a substantial number of patients do not respond to initial therapies, indicating a pressing need for innovative and effective treatment options.

Cybin's commitment to mental health is further underscored by their development of CYB003, a deuterated psilocybin analog for the treatment of major depressive disorder. The company has reported positive progress with CYB003, including a successful End-of-Phase 2 meeting with the FDA, Breakthrough Therapy Designation, and promising durability data, setting the stage for a pivotal Phase 3 study.

Cybin's mission is supported by a network of esteemed partners and scientists, all working towards advancing drug discovery platforms, innovative delivery systems, and novel treatment approaches. The company's dedication to research and development is evident in their pursuit of psychedelic-based compounds that have the potential to transform the landscape of mental health treatment.

With the topline safety and efficacy data from the Phase 2 CYB004-002 study anticipated in the fourth quarter of 2024, Cybin is poised to contribute significantly to the field of mental health. The company's innovative approach to treating GAD and other mental health conditions reflects a forward-thinking strategy that could lead to a new era of therapeutic interventions.

About Cybin

Established in 2019 and headquartered in Canada, Cybin is a clinical-stage biopharmaceutical company with a vision to create safe and impactful psychedelic-based therapeutics. The company's operational presence extends across Canada, the United States, the United Kingdom, the Netherlands, and Ireland.