atai Life Sciences (NASDAQ:ATAI, ETR:9VC) has announced positive topline results from Beckley Psytech’s Phase 2a study of BPL-003 (intranasal 5-MeO-DMT benzoate) in alcohol use disorder.
The company said a single dose of BPL-003 in combination with relapse prevention therapy produced “meaningful and sustained reductions” in alcohol use, with the mean number of alcohol units consumed per day decreasing from 9.3 units to 2.2 units.
The mean percentage of heavy drinking days, defined as consuming seven or more alcohol units daily for women and nine or more for men, dropped from 56% to 13% by Week 12.
Meanwhile, the average number of abstinent days rose from 33% to 81% over the same period and 50% of patients maintained complete abstinence for 12 weeks.
BPL-003 was also well-tolerated, with no serious or severe adverse events reported.
“We are encouraged by these exploratory results from Beckley Psytech, our strategic investment, which demonstrate the potential of short in-clinic psychedelic therapies to transform the treatment of substance use disorders,” atai CEO and co-founder Dr Srinivas Rao said.
“The high rates of sustained abstinence in this study are particularly promising given the significant challenges patients with alcohol use disorder face in achieving and maintaining abstinence.”
Beckley Psytech aims to explore future development pathways for BPL-003 in treating substance use disorders and expects to share further clinical data from this study through publications and conferences in 2025.
Rao said that these findings added to the growing evidence supporting BPL-003’s promise as a treatment for mental health conditions.
“We look forward to the Phase 2b data readout of BPL-003 in treatment-resistant depression expected mid-year,” Rao said.