Beckley Psytech is joining the hunt for an alcohol use disorder treatment with a Phase IIa trial testing its fast-acting psychedelic compound.
UK-based Beckley Psytech announced the initiation of a Phase IIa trial investigating its lead candidate BPL-003 (NCT05674929) in 12 patients with alcohol abuse disorder. The biotech expects to treat the first patient this month, with preliminary results available later this year.
BPL-003 is a synthetic formulation of mebufotenin (5-MeO-DMT), a psychedelic of the tryptamine class naturally found in several plant species and the glands of at least one toad species. The compound could illicit psychedelic experiences of similar intensity but shorter duration than psilocybin, which has shown early promise in substance abuse disorders.
In a previous Phase I trial of BPL-003 (NCT05347849), there were no reported serious adverse events and all consciousness-altering effects resolved within 90 minutes of dosing. Beckley Psytech is also running a Phase IIa trial of BPL-003 in treatment resistant depression (NCT05660642), which has an estimated completion date of October 2023.
Alcohol use disorder affects more than 100 million people globally.
Phase IIa trial design
In the Phase IIa trial of BPL-003, patients will receive a single dose of intranasal BPL-003 alongside a cognitive behavioral psychological intervention focused on abstinence. Patients will then be followed for 12 weeks, with multiple check-ups during that period.
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The trial’s primary endpoints include measures of safety and pharmacokinetics, as well as the Columbia Suicidality Rating Scores (CSSRS) to assess suicidal ideation and behavior. Secondary endpoints include the percentage of patients experiencing a complete mystical experience and ego dissolution, according to the trial listing.
The psychedelic Phase II trial in alcohol use disorder will take place in King’s College Hospital, London, UK. has an estimated completion date of October 2023.
Alcohol use disorder and pharma
As awareness of alcohol use disorder increases, drug development activity has been on the rise. Adial Pharmaceuticals is exploring regulatory pathways for its genetically tested pill for alcohol use disorder, AD04, which had a positive Phase III trial last summer. Meanwhile, other companies are pursuing digital health solutions to counter substance use disorders.
Nevertheless, Clinical Trials Arena found that academic institutions sponsor most ongoing clinical trials for substance disorders, raising concerns that pharma is neglecting the high unmet need.