OXFORD, UNITED KINGDOM - 20 JUNE 2024. Beckley Psytech Ltd, the private, clinical-stage biopharmaceutical company developing effective and rapid-acting psychedelic medicines for neuropsychiatric disorders, today announced initial results from a Phase I study of ELE-101 - a patent-protected synthetic formulation of psilocin benzoate - and that the first patients have been dosed in a Phase IIa study (NCT05434156) of ELE-101 for MDD.
The open-label Phase IIa study will evaluate the safety, tolerability, subjective effects and efficacy of a single intravenous dose of ELE-101 in 6-12 patients diagnosed with MDD. Patients will be assessed at various time points in the study for up to three months following the dose and results of the study are expected in H2 2024.
The dose was selected using preliminary PK/PD data from Beckley Psytech’s double-blind, placebo-controlled, randomised Phase I study of ELE-101 which sought to identify a dose that was well-tolerated and induced high-intensity, short-duration psychedelic experiences in healthy participants. The data indicated that ELE-101 was well-tolerated with no serious or severe adverse events reported and an AE profile which is consistent with other compounds in this class. ELE-101 also had a dose-proportional pharmacokinetic profile and demonstrated a reliable induction of high-intensity, short-duration psychedelic experiences, which suggest the potential for a short time in clinic of approximately 2 hours. If validated in further studies, these findings could support a scalable treatment model that would fit within the existing treatment paradigm that has been successfully established by Spravato®. Full data from the Phase I study is expected to be published at a later date.
Psilocin is the active metabolite of psilocybin and ELE-101 has been specifically designed to provide consistent and controllable drug delivery in patients with neuropsychiatric conditions. The compound has the potential to produce a more rapid onset, significantly shorter treatment duration and reduced inter-subject variability compared to oral formulations of psilocybin. This could offer greater convenience and therapeutic benefits for patients living with depression, whilst lowering the resource burden on healthcare systems and practitioners.
Commenting on the news, Dr Rob Conley, Beckley Psytech’s Chief Scientific and Medical Officer, said: “Dosing the first patients in our Phase II study marks an important milestone in our clinical development programme of ELE-101 as we investigate its potential as an effective and rapid-acting intervention for depression. This study builds on the foundational work from our Phase I study in healthy volunteers and we plan to share more detailed findings from that trial at a later date. We are proud to be leading the way in exploring how short-duration psychedelics like ELE-101 could address the huge unmet need faced by the millions of people living with depression around the world and the healthcare systems who support them.”
ELE-101 is the second clinical-stage asset in Beckley Psytech’s portfolio of potentially rapid-acting, short-duration psychedelic treatment options. BPL-003, a patent-protected synthetic benzoate salt formulation of the psychedelic 5-MeO-DMT (also known as mebufotenin), is Beckley Psytech’s lead compound and is currently in Phase II studies for Treatment Resistant Depression and Alcohol Use Disorder. Initial results from a Phase IIa study of BPL-003 for Treatment Resistant Depression in March 2024 showed that a single 10mg dose of BPL-003 produced a rapid antidepressant response in 55% of patients the day after dosing and this antidepressant effect was durable, with 55% of patients in remission from depression at day 29 and 45% in remission at day 85. BPL-003 also demonstrated a short treatment duration, with acute effects resolving and patients deemed ready to be discharged by Investigators within an average time of less than 2 hours.
For more information please contact: Charlotte Chorley, Communications Lead, at info@beckleypsytech.com
Beckley Psytech - www.beckleypsytech.com
Beckley Psytech Ltd is a private, clinical-stage biopharmaceutical company dedicated to improving the lives of people living with neuropsychiatric disorders by developing effective and rapid-acting psychedelic medicines. Founded in 2019, and underpinned by more than two decades of pioneering scientific research from the Beckley Foundation, Beckley Psytech 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. The company’s lead compound, BPL-003, is a novel, synthetic 5-MeO-DMT benzoate salt formulation currently under investigation in Phase II studies as a potential therapy for Treatment Resistant Depression (TRD) and Alcohol Use Disorder (AUD). BPL-003 is covered by granted US, UK and European composition of matter patents, with multiple further claims pending in various jurisdictions. Beckley Psytech’s second clinical-stage asset, ELE-101, is a proprietary intravenous formulation of psilocin currently being developed as a potential treatment for Major Depressive Disorder (MDD).
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