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Cybin Receives Institutional Review Board Approval For Its Phase 1/2a Clinical Trial Evaluating CYB003 For The Treatment Of Major Depressive Disorder

Cybin Inc. (NEO:CYBN) (NYSE:CYBN) (Cybin or the "Company"), a biopharmaceutical company focused on progressing "Psychedelics to TherapeuticsTM", today announced that it has received

Benzinga · 06/09/2022 16:02

Cybin Inc. (NEO:CYBN) (NYSE:CYBN) (Cybin or the "Company"), a biopharmaceutical company focused on progressing "Psychedelics to TherapeuticsTM", today announced that it has received Institutional Review Board ("IRB") approval to begin the first-in-human Phase 1/2a clinical trial evaluating CYB003, its proprietary deuterated psilocybin analog, for the treatment of major depressive disorder ("MDD").

"IRB approval of our trial protocol is a significant regulatory milestone for CYB003 as it leads us one step closer to potentially providing this important treatment option to people in need. The team has worked tirelessly to move this program into the clinic, and we look forward to initiating the study in mid-2022 and further supporting our mission to develop psychedelics into therapeutics," said Doug Drysdale, Chief Executive Officer of Cybin.

In May 2022, the Company announced that it had submitted an Investigational New Drug application to the U.S. Food and Drug Administration (FDA) for the Phase 1/2a clinical trial. Cybin IRL Limited, a wholly owned subsidiary of Cybin, has engaged Clinilabs Drug Development Corporation, a global, full-service contract research organization with deep expertise in central nervous system drug development, to carry out the Phase 1/2a clinical trial of CYB003.