Beckley Psytech has announced the successful completion of its Phase I clinical study of lead candidate BPL-003, a novel benzoate formulation of 5-MeO-DMT.
The synthetic intranasal formulation of 5-MeO-DMT is under development for Treatment Resistant Depression (TRD) and Alcohol Use Disorder (AUD).
The double-blind, randomised, single ascending dose study explored the safety, tolerability and pharmacokinetics of BPL-003 in combination with psychological support in 44 psychedelic-naïve participants.
The participants were split into six cohorts and were given either a single dose of BPL-003 between 1 mg to 12 mg or a placebo.
Initial results show a dose-proportional pharmacokinetic profile and good tolerability with no serious adverse events reported.
BPL-003 demonstrated rapid onset of effect within minutes and a short duration of experience, with all consciousness-altering effects resolving within 90 minutes.
CSO of Beckley Psytech, Dr Steve Wooding, said: “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 II studies in the coming weeks.”
With the robust data generated thus far from this Phase I study, Beckley Psytech is now preparing to initiate its MHRA-approved Phase IIa studies evaluating BPL-003 in Treatment Resistant Depression and Alcohol Use Disorder in Q4 2022.
CEO of Beckley Psytech, Cosmo Feilding Mellen, added: “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.”
