Canadian biotech Cybin has received approval from the Institutional Review Board (IRB) at the University of the West Indies Hospital in Jamaica for a Phase II trial of its psilocybin formulation, CYB001, to treat major depressive disorder (MDD).
The trial will be started after the Jamaican Ministry of Health confirms study material specifications.
As per the National Institute of Mental Health, more than 7.1% of adults in the US suffered MDD in 2017. The World Health Organization statistics reveal that about 300 million people of the global population have depression.
The US Food and Drug Administration awarded breakthrough therapy designation to psilocybin formulation of different firms in the country.
This Phase II trial will assess Cybin’s sublingual psilocybin formulation versus a 25mg psilocybin capsule. A Phase IIa study will enrol 40 patients to determine the bio-equivalent dose of CYB001 when compared to a 25mg capsule.
Cybin expects sublingual delivery to allow quick absorption of molecules into the bloodstream through the mouth, instead of the gastrointestinal tract.
The objective is to evaluate the potential benefits of the sublingual delivery approach, which focuses on rapid onset of action, shorter duration of therapy and a lower effective dose.
Cybin CEO Doug Drysdale said: “We are planning several additional studies to expand our clinical understanding of this potentially ground-breaking therapeutic.
“Cybin continues to expand on its four active drug programs targeting depression, addiction and other psychiatric conditions alongside its growing portfolio of 50+ proprietary psychedelic molecules.”
If the Phase IIa study yields positive results, the company will conduct a randomised, placebo-controlled Phase IIb study of the formulation in 120 MDD patients.
This study’s primary endpoint will be a decrease in the Montgomery-Asberg Depression Rating Scale (MADRS) of depression symptoms at 30 days.
In 2019, healthcare company Compass Pathways reported positive data from a Phase I trial evaluating the safety of COMP360 (psilocybin) for the treatment of depression.