The first healthy, psychedelic-naïve volunteers have been dosed in Beckley Psytech’s Phase I clinical trial assessing safety and pharmacokinetics of its second innovative formulation of 5-MeO-DMT – BPL-003.
BPL-003 is Beckley Psytech’s innovative dry powder intranasal formulation of 5-MeO-DMT using FDA-approved intranasal delivery devices.
The Phase I study aims to further understand the clinical and pharmacological potential of 5-MeO-DMT, and its data will be used to select lead compound for upcoming Phase II trial in treatment resistant depression (TRD).
Designed as a double-blind, randomised, single ascending dose study, it will recruit up to 36 participants (dependent on response) in six cohorts of six healthy volunteers on increasing doses.
Dr Frank Wiegand, chief medical office 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 I 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 II studies in TRD and the other indications we will be exploring.”
The first Phase I study is being conducted as part of an ongoing collaboration with King’s College London and is being led by Dr James Rucker, and is 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.
Beckley Psytech states that 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 I studies will be analysed to determine which formulation will be used in the upcoming Phase II 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.
Cosmo Feilding Mellen, CEO of Beckley Psytech, stated: “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.”
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