Cybin Inc. CYBNthe biopharmaceutical company “focused on advancing psychedelics into therapeutics” by creating safe and effective therapies for patients to treat a variety of mental health disorders, has received Institutional Review Board approval to launch the first Phase 1/2a clinical trial assess CYB003 for the treatment of major depressive disorder.
An Institutional Review Board, a group constituted under FDA regulations, is appointed to review and oversee biomedical research involving human subjects, with the goal 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 goal is to launch the study in mid-2022. Through Cybin IRL Limiteda wholly owned subsidiary of Cybin, the company has hired Clinilabs drug development companya contract research organization specializing in central nervous system drug development, to complete the Phase 1/2a clinical trial of CYB003.
The psychedelic tested
As its creators explained, CYB003 is a deuterated compound derived from psilocybin, which is part of a family of molecules called indoleamines which 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 a better overall patient outcome,” the company said. . According to Cybin, this psilocybin analog has the potential to effectively treat not only major depressive disorder, but alcohol use disorder as well.
Photo courtesy of Josh Riemer on Unsplash.