Beckley Psytech has announced that a Phase 1 SAD study of its BPL-003 intranasal dry powder synthetic 5-Methoxy-N, N-Dimethyltryptamine (5-MeO-DMT) found that the PK profile was dose proportional and consciousness altering effects of the drug were short-lived. The study enrolled 44 patients aged 25-55 who received single doses of BPL-003 up to 12 mg or placebo.
The company, which is developing BPL-003 for the treatment of alcohol use disorder and treatment-resistant depression, said that it anticipates initiating a Phase 2a study of BPL-003 by the end of 2022. Beckley previously developed a liquid intranasal formulation of 5-MeO-DMT and announced the initiation of an earlier Phase 1 study in October 2021.
Beckley Psytech Chief Scientific Officer Steve Wooding commented, “We are pleased to report such positive initial findings from this Phase 1 study of BPL-003 and look forward to sharing a more detailed analysis soon. The safety and tolerability profile, as well as the reliable induction of psychedelic experiences thus far, lay strong clinical foundations for BPL-003’s next stage of development and we are excited to move forward with our Phase 2 studies in the coming weeks.”
CEO Cosmo Feilding Mellen said, “Beckley Psytech is making great progress in bringing this innovative formulation of 5-MeO-DMT to patients living with underserved conditions like treatment resistant depression. We are particularly impressed with the fast onset and highly controllable delivery action of BPL-003, which we hope will improve accessibility for both physicians and patients. We look forward to delivering further updates on the progression of BPL-003’s clinical development soon.”
Read the Beckley Psytech press release.
