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FDA Approves First Psilocin Clinical Trial

holding a mushroom

Exclusively-natural psychedelic drug discovery company Filament Health Corp. (OTCQB: FLHLF) (NEO: FH)  received authorization from the FDA authorization to initiate the first clinical trial using naturally-sourced psychedelic substances. The news caused the stock to jump over 11% in early trading.

The company said that this approval is the first for the direct administration of psilocin rather than its prodrug psilocybin and will administer Filament’s three proprietary botanical drug candidates. The phase 1 trial is led by the Translational Psychedelic Research Program (TrPR) at the University of California San Francisco (UCSF).

“We are excited to announce this milestone as validation of our ability to cultivate variable psychedelic biomass and transform it into pharmaceutical-grade drug candidates,” said Chief Executive Officer, Benjamin Lightburn. “Our innovative technology has allowed us to create IP-protected botanical drug candidates of oral psilocin, sublingual psilocin, and oral psilocybin, and to enter them into an FDA-approved natural psychedelic clinical trial. Our candidates enjoy significant IP protection, unlike most other psychedelics currently under clinical investigation.”

The phase 1 trial has been designed to include 20 healthy subjects and will examine the effects of Filament’s three proprietary botanical drug candidates: PEX010 (oral psilocybin), PEX020 (oral psilocin), and PEX030 (sublingual psilocin). As a result of the need for psilocybin to convert into psilocin before becoming active in the human body, the direct administration of psilocin may yield several therapeutic benefits such as faster onset time, greater consistency, increased bioavailability, and lessened side effects. These potential attributes are being studied in the authorized trial. In addition, psilocin is an ideal candidate for sublingual delivery because of the bypassing of the gut, where the conversion to psilocybin is thought to primarily occur. To date, synthetic manufacturers have been unable to produce a stable formulation of psilocin and enter it into a clinical trial.

“My team and I are very excited to begin dosing Filament’s drug candidates in our clinic,” said Dr. Josh Woolley, MD/Ph.D., Director of TrPR and the study’s Principal Investigator. “The oral and sublingual administration presents an opportunity to learn about psilocin’s effects compared to psilocybin and perhaps set a new standard for psychedelic assisted therapy.”

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