Beckley Psytech has completed its Phase I clinical study of BPL-003, a synthetic intranasal formulation of 5-Methoxy-N, N-Dimethyltryptamine (5-MeO-DMT).
The drug is under development for Treatment Resistant Depression and Alcohol Use Disorder and was assessed in combination with psychological support in 44 psychedelic-naïve participants.
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.
Cosmo Feilding Mellen, CEO of Beckley Psytech, commented: “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.”
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, added: “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.”
