atai Life Sciences 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.

60% 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 higher (12 mg) dose stating they would accept the same or higher dose again.

BPL-003 is currently under investigation in Phase 2a studies as a potential treatment for Alcohol Use Disorder (NCT05674929) and Treatment Resistant Depression (TRD) (NCT05660642). It is also being explored in a multi-site Phase 2b study (NCT05870540) for TRD. The trial is evaluating the effects of a single, medium, or high dose of BPL-003 against a sub-perceptual dose in TRD patients not taking concomitant antidepressants.

Initial results from that study are expected in H2 2024.