Cybin prepares for GMP manufacturing of CYB003 capsules for Phase 3 trial

Cybin, a clinical-stage biopharmaceutical company committed to revolutionizing mental healthcare by developing new and innovative psychedelic-based treatment options, today announced that it has initiated preparations for good manufacturing practices production of a capsule formulation of CYB003, its proprietary deuterated psilocybin analog in development for the potential treatment of Major Depressive Disorder . The Company has developed a robust solid dosage capsule form of CYB003 designed to be stable, dose flexible, patient-friendly, and commercially scalable, to be evaluated in a potential Phase 3 trial. In its current Phase 2 MDD study, CYB003 dosing is underway in the final cohort. Topline efficacy data is expected in Q3/Q4 of 2023, after which the Company intends to submit data to the U.S. Food and Drug Administration for an end of Phase 2 meeting. “The development of a capsule formulation of CYB003 represents a meaningful advancement toward a commercially viable and more convenient dosing option that is potentially suitable for a future Phase 3 trial. We are very pleased with the progression of our CYB003 program in MDD thus far. Preparations for GMP manufacturing of CYB003 capsules continue to build on our efforts to progress an improved treatment option for people with major depressive disorder,” said Doug Drysdale, Chief Executive Officer of Cybin. “Coupled with our partnership with Worldwide Clinical Trials, a global CRO with deep expertise in psychedelic clinical trials, and the development of EMBARKCT, a scalable model of our psychedelic facilitation program, these efforts are a testament to our clinical execution and capabilities at each step along our development pathway.”