Beckley Psytech, a private, clinical-stage biotechnology company dedicated to addressing neuropsychiatric conditions through the novel application of psychedelic medicines, has completed 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, randomized, 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 1mg and 12mg or a placebo.
Initial results showed 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 data generated thus far from the study, Beckley Psytech said it 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.
Strong foundations for Beckley Psytech’s lead candidate
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.”