Cybin Inc. CYBN, the biopharma company ‘focused on progressing Psychedelics to Therapeutics’ by creating safe and effective therapeutics for patients to address various mental health disorders, has received Institutional Review Board approval to launch the first-in-human Phase 1/2a clinical trial evaluating CYB003 for the treatment of major depressive disorder.
An Institutional Review Board, a constituted group under FDA regulations, is designated to review and monitor biomedical research involving human subjects, with the aim of protecting their rights and welfare. The board has the authority to approve, require modifications (for potential approval), or disapprove research, in accordance with FDA guidelines.
On their behalf, the company’s aim is to initiate the study in mid-2022. Through Cybin IRL Limited, a wholly-owned subsidiary of Cybin, the company has hired Clinilabs Drug Development Corporation, a contract research organization with expertise in central nervous system drug development, to carry out the Phase 1/2a clinical trial of CYB003.
The psychedelic being tested
As explained by its creators, CYB003 is a deuterated compound derived from psilocybin, which is part of a family of molecules called indoleamines that include other neurotransmitters such as serotonin. Psilocybin is dephosphorylated to form its metabolite, psilocin, which can cross the blood-brain barrier.
Given its structural similarity to serotonin, psilocin can easily activate the serotonin 5-HT2A receptor. CYB003 was designed “to achieve less variability in plasma levels, faster onset of action, shorter duration of effect and potentially better tolerability for an overall better outcome for patients”, the company stated. According to Cybin, this psilocybin analog has the potential to effectively treat not only major depressive disorder but alcohol use disorder as well.
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