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Oxford, United Kingdom – 24 APRIL 2023 - ������Ƶ Ltd, a private, clinical-stage biotechnology company dedicated to addressing neuropsychiatric disorders by transforming psychedelics into effective and licensed medicines, has announced that it will be presenting data from its Phase I study of BPL-003 at the in San Diego, California, on the 27th - 29th April. Dr Frank Wiegand, Chief Medical Officer at ������Ƶ, will deliver a poster presentation, titled Intranasal 5-MeO-DMT: Safety, PK and Effect on Altered States of Consciousness in Healthy Volunteers, on the 27th April from 5:30pm - 7:30pm PDT.��

BPL-003 is ������Ƶ’s novel synthetic formulation of the psychedelic compound 5-MeO-DMT (also known as Mebufotenin) and is administered intranasally via an FDA-approved delivery device. ������Ƶ’s Phase I study exploring the safety, tolerability and pharmacokinetics of BPL-003 in combination with psychological support in 44 psychedelic-naïve participants was successfully completed in November 2022. In the double-blind, randomised, single ascending dose study, BPL-003 was shown to be well-tolerated, with consistent dose delivery, a highly reproducible pharmacokinetic profile and a reliable induction of profound psychedelic experiences when dosed up to 12mg in healthy participants. BPL-003 also demonstrated rapid onset of effect within minutes and a short duration of experience, with all consciousness-altering effects resolving within 90 minutes.

Data generated from this study has been used to support the initiation of ������Ƶ’s Phase IIa studies investigating BPL-003 for Treatment Resistant Depression (TRD) and Alcohol Use Disorder, as well as the design for ������Ƶ’s upcoming global Phase IIb study of BPL-003 for TRD. ������Ƶ received the Food and Drug Administration’s (FDA) first ever Investigational New Drug (IND) approval for a Phase IIb clinical trial of a short-acting psychedelic in February 2023. The study, which is due to take place at 40 investigator sites across 7 different countries, will evaluate the effects of a single medium or high dose of BPL-003 against a sub-perceptual dose in patients with moderate to severe TRD. Initial results from that study are expected in 2024.��

Commenting on his upcoming presentation at the Society of Biological Psychiatry’s Annual Meeting, Dr. Frank Wiegand said: “I am very excited to present data from our Phase I study of intranasal BPL-003 on behalf of the co-authors from King’s College London at this prestigious meeting of the Society of Biological Psychiatry and I look forward to engaging in a scientific discussion about our findings with some of the 1,600 healthcare professionals who will be attending the event.”

For more information please contact: Charlotte Chorley, Communications Lead, info@beckleypsytech.com��

About ������Ƶ - ��

������Ƶ Ltd is a private, clinical stage biotechnology company dedicated to improving the lives of people suffering from neuropsychiatric disorders by transforming psychedelics into effective and licensed medicines. The company’s most advanced programmes are focused on the development of psychedelic-based medicines to treat people with Treatment Resistant Depression (TRD), Alcohol Use Disorder (AUD) and Major Depressive Disorder (MDD). Founded in 2019, and underpinned by more than two decades of pioneering scientific research from the ������Ƶ Foundation, ������Ƶ combines world-leading psychedelic science with extensive drug development expertise in order to optimise patient outcomes, improve treatment opportunities and ease the burden neuropsychiatric conditions have on individuals, healthcare systems and society.

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