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Press release

• Phase 1 trial is evaluating the safety and tolerability of a novel formulation of intranasal 5-MeO-DMT
• Study will measure detailed pharmacokinetics and metabolism of 5-MeO-DMT in healthy volunteers
• Preliminary data, expected H1 2022, to support Phase 2 study designs investigating the use of 5-MeO-DMT in treatment resistant depression (TRD) and other neuropsychiatric indications

Oxford, United Kingdom – 25 October 2021 - ������Ƶ, a private company dedicated to addressing neurological and psychiatric disorders through the novel application of psychedelic medicines, announced that the first cohort of volunteers has been dosed in a clinical trial exploring the safety of ������Ƶ's novel formulation of intranasal 5-Methoxy-N,N-Dimethyltryptamine (5-MeO-DMT).

The is designed as a double-blind, randomised, single ascending dose study to evaluate the safety and tolerability of a single intranasal dose of 5-MeO-DMT in psychedelic-naïve healthy subjects. This is the first clinical study to measure the pharmacokinetics and metabolism of 5-MeO-DMT delivered intranasally.

The study will recruit up to 42 participants (dependent on response) in 6 cohorts of 7 volunteers on increasing doses of 5-MeO-DMT. Blinded data from the study will be used to inform the planned Phase 2 study dose and design in H1 2022. The trial is being conducted as part of ������Ƶ’s ongoing collaboration with King’s College London and is being led by Dr James Rucker.

James Rucker, Clinician Scientist and Principal Investigator of the study, the Institute of Psychiatry, Psychology & Neuroscience at King's College London, said: “We are pleased to be working with ������Ƶ and to have initiated this study to evaluate the safety and tolerability of 5-MeO-DMT. TRD is a challenging condition to treat, and it is exciting to be exploring new treatment options that could have a positive impact on patients’ lives in the future.”

Cosmo Feilding Mellen, CEO of ������Ƶ, said: “The start of this Phase 1 study is hugely exciting for ������Ƶ and for our continued collaboration with Dr James Rucker and his team at King’s College London. This trial will provide invaluable information about our novel intranasal formulation of 5-MeO-DMT, and we are looking forward to the readout in 2022. Following this trial, we intend to initiate a Phase 2 study in TRD, a condition with a significant unmet medical need. This is another key milestone achieved on our path to deliver on our clinical pipeline.”

Phase 1 study overview

The Phase 1 study is a double-blind, randomized, single ascending dose trial, with psychedelic-naïve subjects. The study will enrol up to 42 volunteers to evaluate the safety, tolerability, and pharmacokinetics of single ascending intranasal doses of 5-MeO-DMT. The trial will also look to characterise the psychedelic experience of the subjects, with interviews carried out by a specialist.

More information about the trial is available on (NCT05032833)

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