Beckley Psytech announces dosing of first healthy volunteers in Phase 1 clinical trial assessing safety and pharmacokinetics of second innovative formulation of 5-MeO-DMT

• Study represents continued efforts to further understand the clinical and pharmacological potential of 5-MeO-DMT
• BPL-003 is Beckley Psytech’s innovative dry powder intranasal formulation of 5-MeO-DMT using FDA approved intranasal delivery devices
• Data from Phase 1 will be used to select lead compound for upcoming Phase 2 in treatment resistant depression (TRD)

Oxford, United Kingdom – 5 April 2022 - Beckley Psytech, a private company dedicated to addressing neurological and psychiatric disorders through the novel application of psychedelic medicines, announced that the first healthy volunteers have been dosed in a Phase 1 clinical trial exploring the safety and pharmacokinetics of BPL-003, Beckley Psytech's second innovative formulation of 5-Methoxy-N, N-Dimethyltryptamine (5-MeO-DMT)

The Phase 1 study is designed as a double-blind, randomised, single ascending dose study to evaluate the safety and pharmacokinetics of BPL-003 in psychedelic-naïve healthy subjects. The study will recruit up to 36 participants (dependent on response) in 6 cohorts of 6 healthy volunteers on increasing doses

A separate Phase 1 study is ongoing, evaluating the safety and pharmacokinetics of BPL-002, a liquid intranasal formulation of 5-MeO-DMT.

While both BPL-002 and BPL-003 are formulations of 5-MeO-DMT, BPL-003 is a benzoate formulation of 5-MeO-DMT and is administered as a dry powder intranasal spray. This dry powder formulation may provide potential benefits in tolerability and absorption characteristics, and could potentially change the manner in which patients experience the treatment. Both BPL-002 and BPL-003 use FDA approved intranasal delivery devices.

The data from both Phase 1 studies will then be analysed to determine which formulation will be used in the upcoming Phase 2 studies, aimed at evaluating the use of 5-MeO-DMT in combination with assisted psychotherapy in the treatment of treatment resistant depression (TRD) and other indications

Dr Frank Wiegand, CMO of Beckley Psytech, said: “At Beckley Psytech patients are at the centre of everything we do. Therefore we are thrilled with the initiation of this second Phase 1 study which is investigating our innovative dry powder formulation for its potential to optimise the delivery of 5-MeO-DMT, through improved tolerability and adsorption characteristics. The results from this study will allow us to determine the optimal formulation for our upcoming proof of concept and Phase 2 studies in TRD and the other indications we will be exploring."

Cosmo Feilding Mellen, CEO of Beckley Psytech, added: “We are committed to exploring the full therapeutic potential of psychedelic medicines. By looking to tailor the potential therapeutic effects of these compounds through dose and delivery mechanisms, such as FDA approved devices, we aim to optimise treatment outcomes and reduce the burden on the patient, healthcare systems and society.”

Phase 1 study overview

The Phase 1 study is a double-blind, randomised, single ascending dose trial, with psychedelic-naïve healthy volunteers. The study will enrol up to 36 volunteers to evaluate the safety and pharmacokinetic characteristics of a dry powder intranasal spray of 5-MeO-DMT. The trial will also look to characterise the psychedelic experience of the subjects, with several scales and micro-phenomenology interviews carried out by a specialist to fully understand the experience of each individual.