Cybin Granted IRB Approval for Phase II Clinical Trials of its Sublingual Psilocybin Formulation for the Treatment of Major Depressive Disorder

Cybin Inc. (OTCMKTS:CLXPF), a biotechnology company focused on progressing psychedelic therapeutics, today announced that the Institutional Review Board (“IRB”) at the University of the West Indies Hospital, in Jamaica has granted approval to commence the study of its sublingual psilocybin formulation (“CYB001”) in a Phase II clinical trial for patients suffering with Major Depressive Disorder (“MDD”). Commencement of the clinical trial is subject to final confirmation of study material specifications by Jamaica’s Ministry of Health.

MDD is a disease that affected over 7.1% of the U.S. adult population in 2017 according to the National Institute of Mental Health. Globally, nearly 300 million people suffer from depression according to the World Health Organization.

Psilocybin has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration to multiple entities in the USA, and this specific trial will become the first of its kind comparing a 25mg psilocybin capsule with Cybin’s proprietary sublingual film formulation.

The clinical trial will consist of a Phase IIa study of 40 patients to identify the bio-equivalent dose of Cybin’s proprietary sublingual psilocybin formulation versus a 25mg oral capsule. Sublingual delivery is designed to enable rapid absorption of molecules into the bloodstream via the mouth, rather than utilizing the gastrointestinal tract. The goal of the trial is to demonstrate the potential benefits of Cybin’s sublingual delivery method which seeks to deliver faster onset of action, shorter treatment duration, and a lower effective dose.

IRB approval for our study protocols is an important step forward to begin testing our proprietary psilocybin formulation delivered via absorption under the tongue in patients with Major Depressive Disorder. We are planning several additional studies to expand our clinical understanding of this potentially ground-breaking therapeutic. Cybin continues to expand on its 4 active drug programs targeting depression, addiction and other psychiatric conditions alongside its growing portfolio of 50+ proprietary psychedelic molecules. This latest IRB approval moves Cybin closer to unlocking the potential of more scalable therapeutics.

Doug Drysdale, Chief Executive Officer.

Upon successful completion of the Phase IIa study, Cybin plans to study the safety and efficacy of its CYB001 psilocybin drug candidate in a randomized, placebo-controlled Phase IIb study, in 120 patients with MDD. The primary endpoint of this study is expected to be a reduction in the Montgomery-Asberg Depression Rating Scale (“MADRS”) of depression symptoms at 30 days.

The clinical trial will adhere to ICH-GCP (“The International Conference on Harmonization-Good Clinical Practice”) guidelines, with the aim to utilize clinical data across the world in jurisdictions such as the United States, Canada and Europe.

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