Filament Health Corp. 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 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.