TORONTO - Cybin Inc. (NYSE American:CYBN) (Cboe CA:CYBN), a clinical-stage biopharmaceutical company, has announced the commencement of a Phase 2 proof-of-concept study for its proprietary deuterated dimethyltryptamine (DMT) molecule, CYB004, targeting the treatment of Generalized Anxiety Disorder (GAD).
This development follows the U.S. Food and Drug Administration's (FDA) clearance of Cybin's Investigational New Drug application for CYB004 in January 2024.
The Phase 2 study is designed as a randomized, double-blind trial, aiming to recruit around 36 participants with moderate to severe GAD. These individuals will be divided into two groups, with one receiving two intramuscular doses of CYB004 and the other a control, three weeks apart.
The primary measure of the study's success will be the change in the Hamilton Anxiety Rating Scale (HAM-A) score six weeks after the second dose. Other assessments will include depression scales, safety evaluations, and quality of life metrics, with a follow-up period of three months and an optional six-month assessment.
Doug Drysdale, CEO of Cybin, expressed optimism about the scalable, short-duration treatment CYB004 could offer, potentially disrupting negative thought patterns associated with anxiety. The company's approach builds on preliminary evidence of effectiveness from a previous trial involving DMT.
Cybin also highlighted recent progress with another of its molecules, CYB003, for the adjunctive treatment of Major Depressive Disorder, including a positive End-of-Phase 2 meeting with the FDA, Breakthrough Therapy Designation, and encouraging four-month durability data supporting a Phase 3 multinational study set for mid-2024.
Anxiety disorders, including GAD, represent a significant medical challenge, with over 40 million adults affected annually in the U.S. alone. The urgency for improved treatments is underscored by the fact that 50% of GAD patients do not respond to first-line antidepressant therapies.
Topline safety and efficacy data from the CYB004 Phase 2 study are expected in Q4 2024. The study's results are anticipated to provide proof of concept for CYB004's efficacy and the duration of its effects.
This news is based on a press release statement and contains forward-looking statements about Cybin's clinical trials and strategies, which are subject to risks and uncertainties. The company's mission is to develop psychedelic-based therapeutics for mental health conditions, with a focus on proprietary drug discovery platforms and innovative treatment regimens. Cybin was founded in 2019 and operates in multiple countries, including the U.S., the U.K., and Canada.
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