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

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Filament Health has initiated dosing in the first FDA-approved clinical trial of naturally derived psychedelic drugs, specifically psilocin and psilocybin, at UCSF’s Translational Psychedelic Research Program. This phase one trial aims to assess the effects of three proprietary botanical drug candidates on healthy adults. The company recently raised $2.5 million to support its development of stabilized formulations, which may enhance treatment efficacy. This marks a significant milestone, as it is the first time psilocin has been directly administered in a clinical trial.

Positive
  • Initiated first FDA-approved trial for naturally derived psilocin and psilocybin.
  • Raised $2.5 million to further develop natural psychedelic therapies.
  • Trial aims to compare effects of three proprietary botanical drug candidates.
Negative
  • None.

​​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

SAN FRANCISCO--(BUSINESS WIRE)-- 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.

ABOUT FILAMENT HEALTH (OTCQB:FLHLF) (NEO:FH) (FSE:7QS)

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.

Learn more at www.filament.health and on Twitter, Instagram and LinkedIn.

Media Relations:

Lauren Carasso

201-913-0400

lauren@mygrasslands.com

Source: Filament Health Corp.

FAQ

What is the purpose of the clinical trial by Filament Health (FLHLF)?

The trial aims to investigate the physiological and psychological effects of orally administered psilocybin, psilocin, and sublingually administered psilocin among healthy adults.

What are the key milestones achieved by Filament Health (FLHLF)?

Filament Health achieved a significant milestone by starting the first FDA-approved clinical trial for naturally derived psychedelic drugs.

How much funding has Filament Health (FLHLF) recently raised?

Filament Health raised $2.5 million to advance natural psychedelic therapies.

Where is the trial for Filament Health (FLHLF) being conducted?

The trial is conducted at the University of California, San Francisco’s Translational Psychedelic Research Program.

What is unique about the psilocin used in the trial by Filament Health (FLHLF)?

This is the first clinical trial to directly administer psilocin, as previous studies have primarily used its prodrug form, psilocybin.

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