Wake Network Receives Approval for Phase 2b Psilocybin Microdosing Trial

TORONTO, May 12, 2021 /CNW/ - Wake Network Inc. ("Wake"), a global leader in psilocybin and medicinal mushroom production and developer of genomics-based integration therapies, is pleased to announce that the company has received conditional ethics board approval from the Ministry of Health and Wellness (Jamaica) to conduct a Phase 2b psilocybin microdosing clinical trial together with the University of the West Indies. The receipt of this ethics board approval marks the completion of the final step towards receiving conditional approval to begin the study.

Today's announcement marks a significant industry milestone towards the commencement of the world's first psilocybin microdosing trial to be conducted using a randomized, placebo-controlled, double-blind method with mushroom-based psilocybin. To date, no known studies have documented the effects of psilocybin microdosing in structured clinical trials. In this trial Wake will use naturally-derived psilocybin mushroom material produced in its facility, distinguishing it from all previous trials with psilocybin that have been conducted using synthetic substances only. This trial, as with all other trials in the Wake pipeline, will be registered at the clinicaltrials.gov database and pre-registered at Open Science to improve the quality and transparency of its research.

Wake's mission is to produce pharmaceutical-grade psychedelics for clinical research and clinical access from biological sources. Quality data on psilocybin microdosing is currently non-existent. This study aims to provide the industry and the psychedelic research community with insights into the effects of psilocybin microdosing on anxiety and depression. Greater research will provide regulators with greater data on psilocybin microdosing efficacy to increase the availability of products over time.

"Microdosing psilocybin is increasingly becoming a popular practice worldwide. Wake is committed to exploring the potential effects that microdosing has on anxiety and depression through controlled clinical research. Our goal is to bring these medicines to a larger group of users in a safe and compliant manner," stated Dr Olga Chernoloz, Chief Medical Officer of Wake Network.

ABOUT WAKE NETWORK, INC.

Wake Network Inc. is a fungi bioscience company focused on advancing, through research, the field of psychedelic and fungi-based therapeutics. To address the growing need for psychedelic-assisted mental health support in medicine and society at large, Wake has partnered with academics, governments and best-in-class mycologists around the world. Wake is currently developing fungus-derived psilocybin and medicinal mushroom products and is making advancements in the engineering of novel psychedelic biologics, while working on proving out their safety through proprietary genetics-based integration therapies.

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