Filament Health Corp (NEO:FH, OTCQB:FLHLF) announced that its psilocybin drug candidate, PEX010, reduced heavy drinking days by more than 50% in a Phase 2 clinical trial targeting patients with alcohol use disorder (AUD).
Conducted at Psychiatric Centre Copenhagen, the study found that participants' heavy drinking days dropped from 53.6% to 16.1% over a 12-week period following a single 25 mg dose of PEX010.
Participants also reported reduced cravings and improved self-efficacy.
The treatment protocol included two preparation sessions, a single high-dose session of PEX010, and two integration sessions, where participants processed the experience with therapists.
The safety profile of the treatment was favourable, with no serious adverse events, and the results were published in the Journal of Psychopharmacology.
"We are thrilled to announce positive results which support the efficacy of PEX010," Filament Health CEO Benjamin Lightburn said in a statement.
"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."
Dr Mathias Ebbesen Jensen, the trial’s co-principal investigator, added that the results highlighted psilocybin’s promising potential as a treatment for AUD.
"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,” Dr Jensen said.