Company study investigating PEX010, Filament’s botanical psilocybin drug candidate, has been authorized by both FDA and Health Canada
Vancouver, British Columbia, June 3, 2024 – Filament Health Corp. (OTCQB:FLHLF) (Cboe CA:FH) (FSE:7QS) (“Filament” or the “Company”), a clinical‐stage natural psychedelic drug development company, today announced Health Canada and the United States Food and Drug Administration (“FDA”) authorization for a Phase 2 clinical trial of PEX010, Filament’s botanical psilocybin drug candidate, for the treatment of methamphetamine use disorder (“MAUD”). This will be the first ever clinical trial to study the safety and efficacy of botanical psilocybin in a MAUD patient population.
There is a critical need for new interventions to support people with MAUD as there are no FDA-approved pharmacotherapies for the treatment of the condition and effective options are extremely limited. It has been suggested that the complexities of MAUD call for a comprehensive approach to treatment that reduces stimulant overdose and relapse. This may not be achievable with solely pharmacological interventions and research has demonstrated that psychedelic-assisted psychotherapy may be a promising approach.
“The prevalence of methamphetamine use disorder has rapidly increased worldwide over the last decade, with the highest rate of use in North America,” said Dr. Christian Schütz, Professor of Psychiatry at the University of British Columbia (“UBC”) and Principal Investigator for the trial. “Existing clinical data indicates that psilocybin shows promise for the treatment of MAUD. Our aim with this trial is to assess the safety and efficacy of PEX010 in the treatment of MAUD, and to evaluate changes in participants’ substance use, cravings, motivation, and recovery capital. We are grateful to Filament Health for funding and facilitating this much-needed research.”
“These authorizations are a significant milestone in Filament’s mission to support the treatment of substance use disorders with naturally-derived psychedelics,” said Benjamin Lightburn, Chief Executive Officer and Co-Founder of Filament Health. “As a Vancouver-based company, the challenges faced by those in our community who are suffering from MAUD and the toxic drug crisis are close at hand. We are proud to sponsor this crucial research, and to partner with Dr. Schütz and his team.”
The randomized, double-blinded, placebo-controlled clinical trial will evaluate approximately 90 patients with amphetamine-type stimulant use disorder. The primary efficacy endpoint is the change in the overall response rate based on clinically assessed criteria over the 3-month treatment period. Additional endpoints will assess safety and tolerability, changes in methamphetamine use and both clinician and patient reported outcomes across a variety of objective and subjective analyses. Patients assigned to the PEX010 arm will be treated with a single dose of PEX010 25mg in addition to psychotherapy. The Company expects to initiate dosing at UBC in the second half of 2024.
This is the second major regulatory milestone relating to Filament’s investigation of PEX010 for substance use disorders (“SUD”). Earlier this year, the Company announced that the FDA accepted an Investigational New Drug (“IND”) application for PEX010 for SUD with an initial study in opioid use disorder (“OUD”).
PEX010 is authorized for investigation in 36 clinical trials worldwide for 14 mental health indications. PEX010 has also been studied extensively in compassionate use cases for major depressive disorder and end-of-life distress.
ABOUT FILAMENT HEALTH (OTCQB:FLHLF) (CBOE CA: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 for clinical development. We are paving the way with what we believe to be the first-ever natural psychedelic drug candidates.
Learn more at www.filament.health and on Twitter, Instagram, and LinkedIn.
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