atai Life Sciences Announces the Publication of Beckley Psytech’s Phase 1 Study of BPL-003 in the Journal of Psychopharmacology

• BPL-003 is Beckley Psytech’s novel patent-protected benzoate salt formulation of 5-MeO-DMT that is administered intranasally.
• BPL-003 was shown to be safe and well-tolerated with a predictable pharmacokinetic profile and a reliable induction of subjective psychedelic effects with single doses of up to 12 mg in healthy participants.
• Subjective psychedelic effects correlated with 5-MeO-DMT exposure and had a rapid onset and short duration, with acute effects resolving in less than two hours.
  

NEW YORK and BERLIN, April 17, 2024 (GLOBE NEWSWIRE) -- atai Life Sciences (NASDAQ: ATAI) (“atai” or “Company”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, today announced the publication of the Phase 1 results of BPL-003, Beckley Psytech’s novel, synthetic, intranasal benzoate salt formulation of 5-MeO-DMT, in The Journal of Psychopharmacology.

The double-blind, placebo-controlled, single ascending dose Phase 1 study explored the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of BPL-003 in combination with psychological support in 44 psychedelic-naïve healthy volunteers. Participants across seven cohorts were given either a single dose of BPL-003 between 1 mg to 12 mg or a placebo.

The paper shows that BPL-003 was safe and well-tolerated with no serious or severe adverse events reported. BPL-003 was rapidly absorbed and eliminated, with 5-MeO-DMT systemic exposure increasing approximately dose‑proportionally. There was a reliable onset of subjective psychedelic effects within minutes, which resolved in less than two hours. If confirmed in larger studies, these findings could support a scalable single dose treatment model fitting within the existing interventional treatment paradigm.

The intensity of the subjective psychedelic experience was shown to correlate with exposure to the compound. The PD endpoint scores of the Mystical Experience Questionnaire (MEQ-30) and Ego Dissolution Inventory (EDI) increased with an increase in the BPL-003 dose. Sixty percent of participants had a ‘complete mystical experience,’ which is defined as reaching or exceeding a score of three on all four subdomains of the MEQ-30 scale, at 10 mg and 12 mg doses of BPL-003. Notably, 87% of participants who received BPL-003 said they would accept the same or higher dose again, with 100% of participants who received the highest (12 mg) dose stating they would accept the same or higher dose again.