Cybin Inc., a clinical-stage biotech company, is advancing its clinical programs for neuropsychiatric disorders. The company’s lead programs, CYB003 and CYB004, are entering late-stage development.
CYB003, a proprietary deuterated psilocin, is being developed for MDD. It received FDA Breakthrough Therapy Designation based on promising preliminary results. A Phase 3 study in MDD will commence shortly, with 30 high-quality clinical sites involved. The study aims to address methodological challenges common in this drug class.
Phase 2 results demonstrated rapid and significant improvements in depressive symptoms with a single dose and sustained effects four months after two doses. The 16mg dose group achieved a 75% remission rate. Additional 12-month Phase 2 efficacy data is anticipated in early Q4 2024.
CYB004, a deuterated N,N-dimethyltryptamine, is being developed for GAD. Its intramuscular formulation is designed for optimal delivery. Phase 2 efficacy and safety results are expected in late 2024 or early 2025.
Cybin has strengthened its R&D team by adding Dr. Atul R. Mahableshwarkar and Dr. Tom Macek, who will lead the CYB003 and CYB004 programs. These experienced drug development executives bring expertise to advance these clinical initiatives.
Cybin believes that with its advanced clinical programs and experienced team, it is well-positioned as a leader in neuropsychiatry and has the potential to transform mental healthcare with innovative treatments for challenging disorders.
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.
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