Kingston, JAMAICA, May 19 – Wake Network, Inc., a Canadian company at the forefront of psilocybin mushroom production and developer of genomics-based integration therapies, announces today that it has completed the first fully-legal and United Nations-compliant importation of psilocybin-containing mushrooms from its Jamaican subsidy into the U.S., having secured all required permits from the U.S. Drug Enforcement Administration (DEA).
Wake is a fungi bioscience company focused on advancing the field of psychedelic and fungi-based therapeutics to address the growing need for effective mental health treatments. Psilocybin, a key psychoactive component in several species of mushrooms, is being heralded as a “breakthrough therapy” for alleviating the symptoms of many mental health disorders.
Wake is developing genomics-based integration therapies (GBIT) which use genetic sequencing identifying gene markers and expression to find the optimal dose and substance for patients to succeed in their treatment. The company says this proprietary therapy also helps ensure that the substance is safe for the individual. It is expected to name a research partner for that program soon.
“From day one, our mission was to break ground in this emerging sector by building the first legal supply chain of psilocybin mushrooms for research,” said Nick Murray, CEO of Wake, which is a privately held company based in Ontario, Canada.
“This industry milestone provides U.S.-based academics and laboratories with greater access to further the study of psilocybin mushrooms as a treatment for mental health disorders, including depression, anxiety, and post-traumatic stress injury,” says Murray. “This is more important than ever as the COVID-19 pandemic and mental health crisis persists,” he continues.
“Wake exporting raw, organic psilocybin to its DEA-licensed manufacturer in California is for the purpose of developing botanically-derived psilocybin products for clinical use. Presently the only practical option is synthetic psilocybin which is both costly, but it’s also not the form of psilocybin that patients have historically used for therapeutic purposes,” says Murray.
Psilocybin Mushrooms Imported From Jamaica to California
Wake’s subsidiary, Wake Jamaica Limited, cultivated the psilocybin mushrooms at its production facility in Manchester, Jamaica. Wake’s DEA-approved laboratory partner in California, a Schedule 1 Controlled Substance license holder, successfully received the company’s first shipment of the mushrooms.
According to Wake, this is the only commercially-produced, federally-legal botanical psilocybin in the U.S.
There are a number of bureaucratic steps for import/export and one is to request a substance through the International Import and Export Authorization System. When Wake applied, the company says it was the first to submit the request to the International Narcotics Control Board (INCB) and the UN office on Drugs and Crime (UNODC).
Prior to Wake’s application, psilocybin was not included on the INCB’s list until the company requested that it be added in April.
Wake Plans Phase 2b Clinical Trials
Wake is currently producing fungus-derived psilocybin and medicinal mushroom products and is making advancements in the engineering of novel psychedelic biologics. It is seeking to prove the safety of these therapies through its proprietary integration therapies.
To that end, the company has received conditional ethics board approval from the Jamaican Ministry of Health and Wellness to conduct a Phase 2b psilocybin microdosing clinical trial in Jamaica together with the University of the West Indies. The ethics board approval marks the completion of the final step towards receiving conditional approval to begin the study.
The psilocybin microdosing trial will be conducted using a randomized, placebo-controlled, double-blind method with mushroom-based psilocybin. According to Wake, no published studies have documented the effects of psilocybin microdosing in structured clinical trials. A U.S.-based clinical study would still need to be approved by the U.S. Food and Drug Administration.
“With the excitement and potential of the psychedelics, we’re proud to be able to open the door to natural psilocybin for patients, the group whose choices are all too often neglected,” says Murray.
Wake will use naturally-derived psilocybin mushroom material produced in its U.S. facility, rather than synthetic psilocybin. As with all other trials in the Wake pipeline, this study will be registered at the clinicaltrials.gov database and pre-registered at the open source data platform Open Science to improve the quality and transparency of its research.
Wake says Wake says it intends to make its clinical trial results freely and widely available to advance the science. “We’re not focused on the land grab of patents, our innovation is through the genomic program,” says Murray.
Pivoting from Retreats to Research
Prior to the pandemic, Wake produced psilocybin retreats in Jamaica. An unaffiliated company, Silo Wellness, is one of a number of organizations that is continuing to offer these services.
Wake has shifted its focus to developing psilocybin-based therapies and is no longer primarily involved in producing retreats. We “are focusing our efforts on research, both fundamental and clinical,” says Dr. Olga Chernoloz, Wake’s Chief Science Officer.
“Through an extensive network of collaborations with commercial and academic research partners we are advancing scientific knowledge in analytics, preclinical and clinical research,” says Dr. Chernoloz.
The clinical research, which is now Wake’s primary focus, is primarily aimed at psilocybin microdosing and the potential benefits of other medicinal mushrooms. Psychedelic retreats based in Jamaica and other locations outside the U.S. have been gaining significant interest in the past several years.
The surge in demand for these services meant that many were conducted by staff lacking knowledge and experience in psychedelic medicine. As research continues to show that psychedelic substances are only a part (albeit a crucial one) of psychedelic-assisted therapy, the therapy portion of these treatments is also integral to the success of intervention.
“In most cases, commercially offered retreats are not equipped for therapy and provide as much as a safe consumption site for the adventurous bunch as well those looking to address some medical conditions,” says Dr. Chernoloz.
Ongoing research shows that psychedelic compounds generally have robust safety profiles and carry the minimal potential for serious adverse events. But Chernoloz says that medical supervision or accessibility is highly desirable.
“While retreats provide great opportunities to look within, expand one’s horizons and get better acquainted with one’s humanity, I am afraid of repeating the mistakes of unstructured use in the ’60s that led to the ban of psychedelics,” says Dr. Chernoloz.
“Looking for silver linings, I think that global pandemic shutdown is curbing unstructured retreats allowing science to gather data, drive regulatory change and make psychedelics a routine therapeutic intervention.”
This story was updated to correct punctuation and grammar.
Image: Nicki Adams using modified photos by Cannabis Pictures