Filament Health Corp. has announced positive results from an open-label Phase 2 clinical trial evaluating its botanical psilocybin drug candidate, PEX010, for the treatment of alcohol use disorder (AUD). The study, conducted at Psychiatric Centre Copenhagen, found that a single 25mg dose of PEX010 significantly reduced alcohol consumption in patients with severe AUD.
The trial results, published in the Journal of Psychopharmacology, demonstrated that participants experienced a substantial decrease in alcohol consumption over the 12-week observation period following treatment. The percentage of heavy drinking days dropped from 53.6% before treatment to just 16.1% at week 12, representing a reduction of more than 50%. Additionally, participants consumed an average of 3.4 fewer drinks per day during the follow-up period.
"We are thrilled to announce positive results which support the efficacy of PEX010," said Benjamin Lightburn, Co-Founder and Chief Executive Officer at Filament Health. "These data reinforce our confidence in the potential of botanical psilocybin to help the millions of people suffering from substance use disorders like AUD. We look forward to advancing to the next stage of development."
Study Design and Treatment Protocol
The Phase 2 study enrolled 10 treatment-seeking adults diagnosed with severe alcohol use disorder. The comprehensive treatment approach included two preparation sessions, followed by a high-dose psilocybin session where participants received 25mg of PEX010, and concluded with two integration sessions.
All participants completed the full therapy course, and the safety profile was favorable with no serious adverse events reported. Beyond the reduction in alcohol consumption, researchers observed rapid and sustained decreases in craving and temptation, along with significant improvements in self-efficacy among participants.
Dr. Mathias Ebbesen Jensen, MD, PhD-student at Psychiatric Centre Copenhagen and the trial's Co-Principal Investigator, emphasized the significance of these findings: "These results highlight the promising potential of psilocybin as a treatment for alcohol use disorder. Our findings suggest that this therapy could offer a much-needed novel approach and we are currently investigating PEX010 for AUD in a larger randomized, placebo-controlled trial to establish firm conclusions."
The Burden of Alcohol Use Disorder
Alcohol use disorder affects millions worldwide and represents a significant public health challenge. Current treatment options for AUD have limited efficacy, with high relapse rates and poor long-term outcomes for many patients. The development of new therapeutic approaches is crucial to address this unmet medical need.
Psychedelic-assisted therapy has emerged as a promising area of research for substance use disorders. Unlike conventional treatments that often require daily medication, the potential for meaningful clinical improvement following a single administration of psilocybin represents a paradigm shift in treatment approach.
Broader Applications and Future Directions
PEX010 is currently authorized for investigation in 51 clinical trials worldwide across 14 different mental health indications, highlighting the broad potential applications of this naturally-derived psychedelic compound.
Filament Health, a clinical-stage natural psychedelic drug development company, focuses on developing standardized, naturally-derived psychedelic medicines. The company's proprietary platform enables the discovery, development, and delivery of natural psychedelic medicines for clinical development.
The positive results from this Phase 2 trial support advancement to larger, more definitive studies. The research team at Psychiatric Centre Copenhagen is already conducting a randomized, placebo-controlled trial to further evaluate PEX010's efficacy in treating alcohol use disorder.
As research in psychedelic medicine continues to evolve, these findings contribute to the growing body of evidence suggesting that psilocybin-assisted therapy may offer new hope for patients struggling with substance use disorders and other mental health conditions that have proven difficult to treat with conventional approaches.
