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Cybin | 6-K: Report of foreign private issuer [Rules 13a-16 and 15d-16]

SEC announcement ·  Mar 15 15:21
Summary by Moomoo AI
Cybin Inc., a clinical-stage biopharmaceutical company, has announced the initiation of a Phase 2 proof-of-concept study for CYB004, its proprietary deuterated DMT molecule aimed at treating Generalized Anxiety Disorder (GAD). The study, which began on March 15, 2024, follows the FDA's clearance of Cybin's Investigational New Drug application for CYB004 in January 2024. The randomized, double-blind study will recruit approximately 36 participants to receive two intramuscular doses of CYB004, with a primary endpoint of change in the Hamilton Anxiety Rating Scale score at six weeks post-second dose. Topline safety and efficacy data are expected in Q4 2024. Cybin's CEO, Doug Drysdale, highlighted the significance of this study in potentially offering a scalable, short-duration treatment for GAD. Additionally, Cybin reported progress on...Show More
Cybin Inc., a clinical-stage biopharmaceutical company, has announced the initiation of a Phase 2 proof-of-concept study for CYB004, its proprietary deuterated DMT molecule aimed at treating Generalized Anxiety Disorder (GAD). The study, which began on March 15, 2024, follows the FDA's clearance of Cybin's Investigational New Drug application for CYB004 in January 2024. The randomized, double-blind study will recruit approximately 36 participants to receive two intramuscular doses of CYB004, with a primary endpoint of change in the Hamilton Anxiety Rating Scale score at six weeks post-second dose. Topline safety and efficacy data are expected in Q4 2024. Cybin's CEO, Doug Drysdale, highlighted the significance of this study in potentially offering a scalable, short-duration treatment for GAD. Additionally, Cybin reported progress on CYB003 for Major Depressive Disorder, including a positive End-of-Phase 2 meeting with the FDA, Breakthrough Therapy Designation, and positive four-month durability data supporting a Phase 3 study. The company aims to address the urgent need for improved therapeutic options in mental health care, with anxiety disorders affecting over 40 million adults in the U.S. annually and a substantial treatment gap existing for GAD patients.

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