Filament Health has confirmed it has begun dosing in the first FDA-approved clinical trial studying the effects of naturally derived psychedelic drug candidates.
The Phase 1 clinical trial is being conducted at the University of California, San Francisco’s Translational Psychedelic Research Program (TrPR).
Carried out under the supervision of Dr Joshua Woolley, it is the first to directly administer psilocin and psilocybin derived from mushrooms, as opposed to lab-created synthetic substances.
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.
Filament Health CEO and co-founder, Benjamin Lightburn, commented: “We are incredibly proud to have reached this milestone in an FDA-approved trial.
“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.”
The trial is investigating three of Filament’s proprietary botanical drug candidates, naturally extracted and stabilised forms of the psychedelic compounds found in certain mushrooms. Historically, manufacturers have been unable to produce psilocin rather than its prodrug form psilocybin, a hurdle Filament overcame through its patented manufacturing processes.
Woolley stated: “We are excited to conduct the first trial of naturally sourced psilocybin and the first modern trial of psilocin from any source.
”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 70 strains of psychedelic mushrooms for research, Filament recently raised $2.5m to continue its work to advance natural psychedelic therapies with the benefits of stabilised formulations, which may offer greater consistency, increased bioavailability, faster onset time, and lessened side effects.
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