Cybin anticipates end-of-Phase 2 meeting with FDA for CYB003 in Q1

Cybin outlined its recent positive Phase 2 CYB003 topline results in MDD and near-term milestones across its clinical-stage deuterated psilocybin and dDMT programs in development for the treatment of multiple mental health conditions. “The recently reported safety and efficacy datasets from our lead clinical programs compare extremely favorably to currently approved treatments for depression and anxiety disorders, where there remain significant unmet needs for patients. The first quarter of 2024 should be another active and productive period for us, as we advance our clinical programs. For CYB003, we expect to have 12-week efficacy data and an end-of-Phase 2 meeting with the U.S. Food and Drug Administration. That discussion will inform the design of a Phase 3 study, which we plan to commence around the end of the first quarter. For our dDMT programs, we plan to initiate a Phase 2 trial of CYB004 in generalized anxiety disorder GAD ,” said Doug Drysdale, Chief Executive Officer of Cybin. “As we look ahead, we see enormous opportunities for progress across our differentiated programs and development pipeline. With each promising dataset, we gain confidence in our ability to revolutionize the treatment of mental health disorders and to give patients and providers hope for longer lasting and improved outcomes.”