Beckley Psytech’s BPL-003, a novel intranasal formulation of 5-MeO-DMT, has demonstrated safety and tolerability in a Phase 1 study, according to a recent publication in The Journal of Psychopharmacology. This study, which involved 44 healthy, psychedelic-naïve volunteers, found that BPL-003 had a predictable pharmacokinetic profile and induced rapid, short-duration psychedelic effects without serious adverse events.
The trial, conducted by atai Life Sciences (NASDAQ: ATAI), explored various dosages ranging from 1 mg to 12 mg. Notably, the highest doses (10 mg and 12 mg) led to a ‘complete mystical experience’ in a significant percentage of participants. The promising results suggest potential for BPL-003 as a scalable, single-dose treatment for mental health disorders, aligning with existing treatment paradigms like Spravato®.
Currently, BPL-003 is advancing into Phase 2a studies targeting Alcohol Use Disorder and Treatment Resistant Depression, with further exploration in a Phase 2b study. These studies aim to validate the efficacy of BPL-003 in larger, more diverse patient populations. atai Life Sciences, having invested in Beckley Psytech earlier this year, holds significant stake and collaborative rights in the ongoing development of BPL-003.
This development is part of atai’s broader mission to innovate in the mental health treatment landscape, focusing on creating efficient therapeutic solutions for depression, anxiety, addiction, and other mental health disorders.