Filament Health Receives Authorization for Phase 2 Clinical Trial of Psilocybin for MAUD Treatment

LOS ANGELES- Filament Health, a psychedelic drug development company, has received authorization from Health Canada and the United States Food and Drug Administration (FDA) to conduct a Phase 2 clinical trial of its botanical psilocybin drug candidate, PEX010, for the treatment of methamphetamine use disorder (MAUD). This marks the first clinical trial to investigate the safety and efficacy of botanical psilocybin in treating MAUD.

The urgent need for new interventions to address MAUD is underscored by the absence of FDA-approved pharmacotherapies and the limited effectiveness of existing options. A comprehensive approach, potentially involving psychedelic-assisted psychotherapy, is suggested to address the complexities of MAUD, including reducing stimulant overdose and relapse.

Dr. Christian Schütz, Professor of Psychiatry at the University of British Columbia (UBC) and Principal Investigator for the trial, highlighted the increasing prevalence of MAUD, particularly in North America. “Existing clinical data indicates that psilocybin shows promise for the treatment of MAUD,” said Dr. Schütz. “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.”

Filament Health’s CEO and Co-Founder, Benjamin Lightburn, emphasized the significance of these authorizations. “As a Vancouver-based company, the challenges faced by those in our community suffering from MAUD and the toxic drug crisis are close at hand. We are proud to sponsor this crucial research and partner with Dr. Schütz and his team.”

The clinical trial, which is randomized, double-blinded, and placebo-controlled, will involve 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 a three-month treatment period. Additional endpoints will assess safety and tolerability, changes in methamphetamine use, and both clinician and patient-reported outcomes. Patients in the PEX010 arm will receive a single 25mg dose of PEX010 combined with psychotherapy. Dosing is expected to begin at UBC in the latter half of 2024.

This trial represents the second major regulatory milestone for Filament Health concerning PEX010’s investigation for substance use disorders (SUD). Earlier this year, the FDA accepted an Investigational New Drug (IND) application for PEX010 for an initial study in opioid use disorder (OUD).

PEX010 is authorized for investigation in 36 clinical trials globally for 14 mental health indications and has been extensively studied in compassionate use cases for major depressive disorder and end-of-life distress.