Clinical-stage natural psychedelics company Filament Health Corp. FLHLF announced it will start providing patients with doses of the first FDA-approved study directly administering psilocin and psilocybin derived from mushrooms, as opposed to manufactured synthetic substances.
The phase 1 clinical trial, to be conducted at the University of California San Francisco's Translational Psychedelic Research Program (TrPR) and supervised by Dr. Joshua Woolley will investigate three of Filament's proprietary botanical drug candidates, naturally extracted and stabilized forms of the psychedelic compounds found in certain mushrooms.
The study’s goal is to compare the physiological and psychological effects of orally-administered psilocybin and 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 Filament CEO and co-founder Benjamin Lightburn, who added that the company is eager to continue increasing the scientific understanding of potential benefits and applications for natural psychedelic medicines, in order to provide treatments to those in need.
On his behalf, director of TrPR and principal investigator Dr. Joshua Woolley, MD/Ph.D. said: "We are excited to conduct the first trial of naturally sourced psilocybin and the first modern trial of psilocin from any source."
According to public statements, this is the first time psilocin -either natural or synthetic- has ever been administered in an FDA-approved clinical trial. That is, manufacturers have been unable to produce psilocin rather than its prodrug form, psilocybin.
Dr. Woolley says he is confident that the trial will provide crucial information about the compounds’ effects & mechanisms, which could in turn allow for an enhanced psychedelic-assisted therapy.
With nearly 70 strains of psychedelic mushrooms for research developed, Filament recently raised $2.5 million to continue its work advancing stabilized formulations for potentially greater consistency, increased bioavailability, faster onset time and reduced side effects.
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