Cybin Inc., a leading biotechnology firm, announced on Wednesday that the Food and Drug Administration (FDA) has approved their Breakthrough Therapy Designation proposal for the innovative psychedelic-based medicine CYB003. The new therapy has been developed to treat Major Depressive Disorder (MDD).
The company further shared results from their Phase 2 clinical trial. This revealed remarkable and continued improvements in depression symptoms amongst participants treated with CYB003. Astonishingly, 75% of the participants achieved remission and displayed no traces of depression after four months of treatment with CYB003.
Based on this encouraging data, Cybin anticipates advancing to a crucial Phase 3 study of CYB003 for treating MDD, setting their sights on mid-2024.
