Filament Health Reports Positive Phase 2 Results for PEX010 in Alcohol Use Disorder

A recent clinical study conducted at the Psychiatric Centre Copenhagen has unveiled promising results indicating that Filament Health's botanical psilocybin drug candidate, PEX010, may significantly reduce alcohol consumption among individuals diagnosed with alcohol use disorder (AUD). The phase 2 open-label trial, which assessed the efficacy and safety of PEX010, involved a single 25 mg dose administered to participants. The findings, now published in the Journal of Psychopharmacology, suggest that this approach could offer a novel therapy for those struggling with AUD.

Over a 12-week period, researchers closely monitored the drinking patterns of ten adults who sought treatment for severe AUD. The trial incorporated two preparatory sessions, the psilocybin dose, and two post-treatment integration sessions. Results showed a remarkable reduction in the mean percentage of heavy drinking days from 53.6% before the treatment to 16.1% at the end of the observation period. Additionally, participants experienced a decrease in daily alcohol consumption by an average of 3.4 drinks. These improvements were supported by reports highlighting sustained reductions in alcohol craving and temptation, along with increased self-efficacy among participants.

Benjamin Lightburn, Co-Founder and CEO of Filament Health, expressed enthusiasm over the trial's outcomes, stating, "We are thrilled to announce positive results which support the efficacy of PEX010. 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."

The safety profile of PEX010 was favorable, as no serious adverse events were reported during the study, and all participants successfully completed the therapy course. Dr. Mathias Ebbesen Jensen, a Co-Principal Investigator of the trial and PhD student at Psychiatric Centre Copenhagen, commented on the significance of the findings, saying, "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."

Filament Health, the company behind PEX010, is dedicated to the development of natural psychedelic medicines. Their platform supports the discovery and delivery of standardized psychedelic therapies aimed at improving mental health. Currently, PEX010 is authorized for investigation in 51 clinical trials worldwide, exploring its potential across 14 different mental health conditions.

These findings represent a significant step forward in the exploration of psilocybin's therapeutic benefits for those battling substance use disorders, particularly AUD. With ongoing trials and continued research, PEX010 could become a pivotal component in the future treatment landscape for AUD, offering patients a chance to experience reduced alcohol dependency and improved quality of life. As Filament Health continues to explore the potential of natural psychedelic therapies, the promise of PEX010 provides hope for the millions affected by alcohol use disorder globally.