Cybin Inc. announced the initiation of a Phase 2 proof-of-concept study of CYB004, its proprietary DMT molecule in development for the treatment of GAD. In January 2024, the U.S. Food and Drug Administration (?FDA?) cleared Cybin?s Investigational New Drug application for CYB004. CYB004 Phase 2 Program Outline The CYB004-002 Phase 2 study is a randomized, double-blind study which will evaluate the safety and efficacy of CYB004 in participants with GAD, with concomitant antidepressant/anxiolytic treatment and co-morbid depression allowed.

The study will recruit approximately 36 participants, who will be randomized in a double-blind manner, into 2 groups: the first group will receive two IM doses of CYB004, three weeks apart, while the second group will receive two low-dose control administrations. The study will enroll participants with moderate to severe GAD and a score of =10 on the GAD-7 anxiety scale. Participants will be followed for a period of three months, with an optional additional assessment at six months.

The primary endpoint is a change in the Hamilton Anxiety Rating Scale (?HAM-A?) score from baseline at six weeks following the second dose. Other endpoints include the Montgomery-Asberg Depression Rating scale depression assessment, safety assessments, MEQ30 (psychedelic experience assessment) and EQ-5D-5L (quality of life assessment). Results from this study are expected to provide proof of concept for CYB004?s efficacy in GAD, the time to onset of effects, as well as durability of effects to six months.

Topline safety and efficacy data from this Phase 2 CYB004-002 study are expected in Fourth Quarter 2024. Significant Unmet Medical Need in Generalized Anxiety Disorder Anxiety disorders affect over 40 million adults in the United States each year. In the U.S., GAD is the most common anxiety disorder seen in primary care, with a 12-month prevalence of 2.9%.

Despite the use of existing therapies, 50% of patients with GAD do not respond to first line treatment with antidepressants such as SSRIs and SNRIs4, highlighting a large treatment gap and urgent need for improved therapeutic options.