Cybin Inc. announced that it has selected Generalized Anxiety Disorder with or without major depressive disorder as the target indication for its proprietary deuterated N, N-dimethyltryptamine molecule, CYB004. Generalized anxiety disorder is characterized by excessive worry and tension that is not restricted to any specific environmental circumstances. Anxiety disorders are the most common mental health concern in the United States.

Over 40 million adults in the U.S. (19.1% of the total U.S. population) have an anxiety disorder. Among psychiatric disorders, GAD and MDD are the leading contributors to global disability. The presence of both GAD and MDD is strongly associated with a poor prognosis, an increase in severe symptoms, poorer quality of life, greater MDD recurrence, and a higher suicide risk than either disorder alone.

GAD affects 6.8 million adults, or 3.1% of the U.S. population, in any given year. Women are twice as likely to be affected by GAD. Worldwide, GAD affects 14.7 million people in any given year.

23 % of adults prescribed an SSRI discontinued medication at 4 weeks and 36.5 % 3 months. Another report indicated that approximately one half of patients disconti antidepressant medication within 3 months. There is a lifetime morbidity risk for GAD, with around 9% prevalence.

Based on a 2022 Generalized Anxiety Disorder Therapeutics Market Report, the economic burden of GAD is expected to grow to USD 12 billion by 2030. Cybin is currently conducting a Phase 1 exploratory trial ("CYB004-E trial") evaluating IV N, N-dimethyltryptamine ("DMT") to yield essential safety and dosing optimization data for the future clinical development of CYB004 for the treatment of GAD. To date, the CYB004-E trial has not demonstrated any clinically significant safety or tolerability issues.

Cybin expects to translate key learnings from the initial study cohorts, including dose optimization and dosing dynamics, to support the remaining planned cohorts in the trial. These learnings are also expected to accelerate Cybin's plans to commence dosing of CYB004 in humans. In its natural form DMT is rapidly metabolized in the body and is not orally bioavailable.

Based on preclinical studies, CYB004 has the potential to overcome the limitations of DMT. Specifically, these data showed that CYB004 had increased oral and pulmonary bioavailability, faster onset with lower doses, low inter-subject variability, and better dose titration for potentially fewer side effects compared with oral and IV DMT. Cybin secured a U.S. composition of matter patent covering CYB004 in February 2022.