Cybin Inc., a biopharmaceutical company focused on developing treatments for mental health disorders, has achieved significant milestones in its research programs.
CYB003 for Major Depressive Disorder (MDD)
• Received FDA Breakthrough Therapy Designation (BTD) for CYB003, a deuterated psilocybin analog.
• BTD accelerates the development process and provides increased FDA guidance on trial design.
• Phase 3 multinational study for CYB003 is expected to begin in summer 2024.
• Positive four-month durability data for CYB003 supports its potential therapeutic benefits.
CYB004 for Generalized Anxiety Disorder (GAD)
• Initiated a Phase 2 study of CYB004, a deuterated dimethyltryptamine program.
• CYB004 is being developed for the treatment of GAD.
Financial Highlights
• Cash on hand totaled C$209 million as of March 31, 2024.
• Closed an oversubscribed private placement of U.S.$150 million.
Intellectual Property
• Strengthened intellectual property portfolio with over 60 granted patents and 200 pending applications.
Company Outlook
Doug Drysdale, CEO of Cybin, noted the company’s rapid progress and evolution into a late-stage company. He emphasized Cybin’s commitment to transformative treatments for mental health disorders and its accelerated path towards potential commercialization.
Cybin’s rigorous research approach aims to revolutionize the treatment of mental health disorders and improve patient outcomes. The company remains well-positioned to continue its regulatory engagement and clinical program advancements in the upcoming year.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
