The trial, conducted at UCSF’s TrPR Lab, is first to use naturally derived psychedelic drug candidates and first to directly administer psilocin, the active form of psilocybin
VANCOUVER, BC, July 7, 2022 /CNW/ – Filament Health Corp. (OTCQB:FLHLF) (NEO:FH) (FSE:7QS) (“Filament”), a clinical-stage natural psychedelic drug development company, today announced the beginning of dosing in the first United States Food and Drug Administration (FDA)-approved clinical trial studying the effects of naturally derived psychedelic drug candidates. The phase one clinical trial, conducted at the University of California, San Francisco’s Translational Psychedelic Research Program (TrPR) under the supervision of Dr. Joshua Woolley, is the first to directly administer psilocin and psilocybin derived from mushrooms, as opposed to lab-created synthetic substances.
The trial is investigating three of Filament’s proprietary botanical drug candidates, naturally extracted and stabilized forms of the psychedelic compounds found in certain mushrooms. The trial objective is to compare the physiological and psychological effects of orally administered psilocybin, orally administered psilocin, and sublingually administered psilocin among healthy adults over a series of exposures.
“We are incredibly proud to have reached this milestone in an FDA-approved trial,” said CEO and Co-Founder Benjamin Lightburn. “We look forward to increasing the scientific understanding of potential benefits and applications for natural psychedelic medicines, and to getting these treatments to those in need.”
“We are excited to conduct the first trial of naturally sourced psilocybin and the first modern trial of psilocin from any source,” said Dr. Joshua Woolley, MD/Ph.D., director of TrPR and the study’s Principal Investigator. “This trial will provide crucial information about the effects and mechanisms of these compounds that could allow for greatly enhanced psychedelic-assisted therapy.”
Having developed some 70 strains of psychedelic mushrooms for research, Filament recently raised $2.5 million to continue its work to advance natural psychedelic therapies with the benefits of stabilized formulations, which may offer greater consistency, increased bioavailability, faster onset time, and lessened side effects. This is the first time psilocin in either a natural or synthetic form has ever been administered in an FDA-approved clinical trial. Historically, manufacturers have been unable to produce psilocin rather than its prodrug form psilocybin, a hurdle Filament overcame through its patented manufacturing processes.
The full design for the clinical trial can be found on clinicaltrials.gov.
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Filament Health is a clinical-stage natural psychedelic drug development company. We believe that safe, standardized, naturally-derived psychedelic medicines can improve the lives of many, and our mission is to see them in the hands of everyone who needs them as soon as possible. Filament’s platform of proprietary intellectual property enables the discovery, development, and delivery of natural psychedelic medicines. We are paving the way with the first-ever natural psychedelic drug candidates.
Certain statements and information contained herein may constitute “forward-looking statements” and “forward-looking information,” respectively, under Canadian securities legislation. Generally, forward-looking information can be identified by the use of forward-looking terminology such as, “expect”, “anticipate”, “continue”, “estimate”, “may”, “will”, “should”, “believe”, “intends”, “forecast”, “plans”, “guidance” and similar expressions are intended to identify forward-looking statements or information. The forward-looking statements are not historical facts, but reflect the current expectations of management of Filament regarding future results or events and are based on information currently available to them. Certain material factors and assumptions were applied in providing these forward-looking statements. The forward-looking statements discussed in this press release may include, but are not limited to, information concerning the impact of the patent on the Company’s business and the ability of the Company to secure future patents. Forward-looking statements regarding the Company are based on the Company’s estimates and are subject to known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of Filament to be materially different from those expressed or implied by such forward-looking statements or forward-looking information, including status of patent applications and the ability to secure patents. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements and forward-looking information. Filament will not update any forward-looking statements or forward-looking information that are incorporated by reference herein, except as required by applicable securities laws.
SOURCE Filament Health Corp.