Pharma Focus America

Filament Health Announces First Dosing in Groundbreaking FDA-Approved Psilocin Clinical Trial

Friday, July 08, 2022

Filament Health Corp., 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.

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