Beckley Psytech successfully completes Phase I clinical study of lead candidate BPL-003, a novel benzoate formulation of 5-MeO-DMT

• BPL-003 shown to be well-tolerated, with consistent dose delivery, highly reproducible pharmacokinetic profile and reliable induction of profound psychedelic experiences when dosed up to 12 mg in healthy participants
• BPL-003 is Beckley Psytech’s patent-protected benzoate formulation of 5-MeO-DMT and is administered intranasally via an FDA-approved delivery device
• MHRA-approved Phase IIa studies of BPL-003 in Treatment Resistant Depression and Alcohol Use Disorder are expected to initiate in Q4 2022

Oxford, United Kingdom – 15 November 2022 - Beckley Psytech, a private, clinical-stage biotechnology company dedicated to addressing neuropsychiatric conditions through the novel application of psychedelic medicines, today announced the successful completion of its Phase I clinical study of BPL-003, a synthetic intranasal formulation of 5-Methoxy-N, N-Dimethyltryptamine (5-MeO-DMT), which is under development for Treatment Resistant Depression and Alcohol Use Disorder.

The double-blind, randomised, single ascending dose study (NCT05347849) explored the safety, tolerability and pharmacokinetics of BPL-003 in combination with psychological support in 44 psychedelic-naïve participants. The participants were split into 6 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 (PK) 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. 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.

Dr Steve Wooding, CSO of Beckley Psytech, 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.”

Cosmo Feilding Mellen, CEO of Beckley Psytech, 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.”