OXFORD, UNITED KINGDOM - 16 DECEMBER 2024. Beckley Psytech Ltd, the private, clinical-stage biopharmaceutical company developing effective, rapid-acting and accessible medicines for mental health conditions, today announced positive topline results from its open-label Phase IIa study of ELE-101 in patients with Major Depressive Disorder (MDD). Initial findings show that ELE-101 can deliver rapid, robust and lasting antidepressant effects for up to 3 months following a single dose.
The study evaluated the safety, tolerability, subjective effects and efficacy of a single intravenous (IV) dose of ELE-101 in 6 patients diagnosed with MDD, commonly known as depression. Initial data show that a single dose of ELE-101, delivered via a 10 minute infusion, induced a rapid and clinically significant antidepressant response in the majority of patients, with these effects sustained in the 4 subjects evaluable at 3 months. There was a 25 point mean reduction in MADRS scores seen the day after dosing, and 4/6 subjects had MADRS scores of 10 or less (considered as remission) immediately the day after dosing. A >20 point reduction in MADRS scores was also observed at all time points through to 3 months after dosing, with all 4 subjects evaluable at day 90 after dosing meeting the remission criteria.
ELE-101 was well-tolerated with mostly mild, transient adverse events and no serious or severe adverse events reported. ELE-101 also demonstrated a short treatment duration, with acute effects resolving and patients deemed ready to be discharged by Investigators within a mean time of approximately 2 hours. This supports the potential for ELE-101 to fit within the interventional psychiatric treatment model that is currently in place for SpravatoⓇ.
The dose for this study was selected using preliminary pharmacokinetic and pharmacodynamic data from Beckley Psytech’s double-blind, placebo-controlled, randomised Phase I study of ELE-101 which completed dosing in Q1 2024. That data showed that ELE-101 was well-tolerated with a dose-proportional pharmacokinetic profile and reliable induction of acute effects.
Commenting on the Phase IIa results, Dr Rob Conley, Beckley Psytech’s Chief Scientific and Medical Officer, said: “These positive initial findings indicate that our innovative intravenous formulation has the potential to provide an effective and rapid-acting treatment option for those suffering from depression, with a good safety and tolerability profile and lasting effects from a single dose. Whilst this was a small, proof-of-concept study, we are greatly encouraged by the results and we are looking forward to planning larger studies of ELE-101 in the coming months.”
ELE-101 is Beckley Psytech's patent-protected, synthetic formulation of psilocin benzoate and has been specifically designed to provide consistent and controllable drug delivery in patients with neuropsychiatric conditions. Through IV delivery of the active metabolite of psilocybin, ELE-101 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 enhance convenience and therapeutic outcomes for patients living with depression and other mental health conditions whilst also fitting within the existing treatment paradigm.
Depression, or MDD, is a common and serious mood disorder that negatively affects how a person feels, thinks and acts. It is estimated that nearly 300 million people around the globe have depression, with around 52 million people suffering from the condition in Europe and the US combined. Treatment for depression usually involves a combination of lifestyle changes, talking therapies and medicines but, for many patients, even the best current medicines either do not work, or have side effects that leave them not feeling like themselves, or unable to experience life to the fullest.
ELE-101 is the second clinical-stage asset in Beckley Psytech’s portfolio of rapid-acting, short-duration treatment options. BPL-003, a patent-protected synthetic benzoate formulation of 5-MeO-DMT, is Beckley Psytech’s lead compound and is currently in Phase II studies for 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
About 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 depression and Alcohol Use Disorder. 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.
Image credit: Greg Dunn
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