As substance use disorders like methamphetamine use disorder continue to rise in North America without effective treatment options, Filament Health Corp (NEO:FH, OTCQB:FLHLF) is taking an innovative approach to address this critical unmet need.
The company’s botanical psilocybin candidate, PEX010, recently received Health Canada approval for a Phase 2 trial to assess its potential in treating methamphetamine use disorder (MAUD), a first for botanical psilocybin in this patient group.
This regulatory approval enables Filament to investigate PEX010’s potential to alleviate methamphetamine dependency, which is a growing concern in North America, where stimulant overdose rates continue to rise.
The trial, conducted in collaboration with the University of British Columbia (UBC) and led by Dr Christian Schütz, Professor of Psychiatry at UBC, will evaluate PEX010’s safety and efficacy in a controlled setting.
The study design includes a randomized, double-blinded, placebo-controlled methodology with about 90 participants. In the psilocybin group, patients will receive a single 25 mg dose of PEX010 combined with psychotherapy.
Key endpoints will track the impact of psilocybin on methamphetamine use, cravings, and overall treatment motivation, alongside clinician- and patient-reported outcomes over a three-month period.
This trial represents the second major regulatory approval for PEX010 related to substance use disorders this year. Earlier, Filament secured US Food and Drug Administration (FDA) Investigational New Drug (IND) approval for exploring PEX010’s impact on opioid use disorder.
In addition to advancing its research program, Filament supplies consistent, naturally derived psychedelic compounds produced at its GMP-certified facility in Vancouver, Canada at low or no cost to academic institutions and via licensing partnerships to commercial entities.
To date, PEX010 is authorized in 36 clinical trials worldwide, covering 14 mental health indications, including major depressive disorder and end-of-life distress.
Notably, in collaboration with Imperial College London, Filament is supporting a landmark clinical trial that will explore psilocybin’s potential role in preventing relapse among individuals recovering from opioid addiction.
Funded by the UK’s National Institute for Health Research, this trial represents the first of its kind in the UK to study psychedelics in addiction treatment.
By providing psilocybin in-kind, Filament enables Imperial’s team to investigate whether psilocybin, combined with psychological support, may help significantly improve recovery outcomes given there are currently limited options for treating opioid dependency.
Filament's advancements in psychedelic therapies are supported by a strong intellectual property (IP) portfolio that enhances its position in the natural psychedelic drug development field.
Recently, the company expanded its global IP with the acceptance of 12 patents by IP Australia, along with the issuance of five patents from the Canadian Intellectual Property Office and three from the United States Patent and Trademark Office.
In total, Filament’s IP portfolio now includes 46 patents across Canada, the US, Australia, and Mexico, covering critical processes like the extraction, purification, standardization, and delivery of naturally derived psychedelic active pharmaceutical ingredients (APIs).
Australia is a key jurisdiction in Filament’s strategy, with the nation in July of 2023 allowing the prescription of psilocybin by authorized psychiatrists for treatment-resistant depression.
Earlier this year, Filament successfully exported PEX010, its botanical psilocybin candidate, to Reset Mind Sciences in Perth, Western Australia, marking what is believed to be the first export of botanical psilocybin to Australia.
Through its own research program and collaborations with leading institutions, Filament Health is at the forefront of advancing psychedelic therapies that address critical gaps in the treatment of substance use disorders and other mental health conditions.