Psychedelic biopharma company Cybin Inc. (NEO: CYBN) has received FDA Investigational New Drug Application (IND) approval for a Phase 1/2a clinical trial evaluating its proprietary CYB003 for treating major depressive disorder (MDD).
The company had previously been granted approval for the study from the Institutional Review Board, a group that works under FDA regulations. The IND acceptance, though, constitutes a milestone as it will be the industry’s first novel psilocybin analog to enter clinical development.
“Multiple academic studies have shown that psychedelic-based treatments, like psilocybin, may have the potential to revolutionize mental healthcare, but few companies have addressed the well-known limitations and side effects of oral psilocybin," said CEO Doug Drysdale. "We believe CYB003 has the potential to offer people in need with a more tolerable and potentially more effective treatment option.”
CYB003 is a deuterated analog of psilocybin, designed to potentially address the challenges and limitations of oral psilocybin. It is included in a family of molecules called indolamines along with more common neurotransmitters such as serotonin.
Preclinical data shows that CYB003 achieved less variability in plasma levels, faster onset of action and shorter duration of effect compared to oral psilocybin.
For the current study, the company is working with drug development Clinilabs. The CYB003 Phase 1/2a trial is a randomized, double-blind, placebo-controlled study evaluating people with moderate to severe MDD. Participants will receive two administrations (placebo/active and active/active) and a response/remission will be assessed at Week 3 (after the first dose) and at Week 6 (after the second dose).
The trial is set to evaluate rapid onset antidepressant effects as well as that of up to two doses of 12mg, providing important pharmacokinetics and safety data to determine a clinical path forward.
An optional open-label follow-up study will assess the durability of the treatment effect for up to 12 weeks.
