OXFORD, UNITED KINGDOM - 24 APRIL 2024. Beckley Psytech Ltd, the private, clinical-stage biopharmaceutical company dedicated to improving the lives of people living with neuropsychiatric disorders by developing effective and rapid-acting psychedelic medicines, announced today that the first patient has been dosed in the second part of its two-part Phase IIa study evaluating BPL-003 in patients with Treatment Resistant Depression (TRD). BPL-003 is Beckley Psytech’s novel, patent-protected, synthetic benzoate salt formulation of the psychedelic compound 5-MeO-DMT (also known as mebufotenin) which is administered intranasally.
In this part of the open-label Phase IIa study (NCT05660642), patients with moderate-to-severe TRD who are also taking certain defined Selective Serotonin Reuptake Inhibitors (SSRIs) will receive a single dose of BPL-003 alongside psychological support in order to explore the safety, tolerability, efficacy and pharmacokinetics of BPL-003 as an adjunctive therapy to SSRIs. Patients will be followed for 12 weeks post-dosing, with assessments conducted at multiple points throughout the period. Initial results from this part of the study are expected to be shared in H1 2025.
Treatment Resistant Depression affects around 30% of people with Major Depressive Disorder, or depression, and is diagnosed when an individual does not respond to two or more antidepressants. Many studies exploring potential new medications for TRD require patients to taper off their existing treatments. However, since TRD is often managed with the use of several interventions, it is important to understand how different treatment options interact, which is why Beckley Psytech is exploring the safety and efficacy of BPL-003 co-administration with SSRIs in this study.
Commenting on the development, Dr. Rob Conley, Chief Scientific and Medical Officer at Beckley Psytech, said: "Understanding the safety, tolerability and efficacy of BPL-003 in people who are taking SSRIs is a critical step in our journey to bringing BPL-003 to market as a safe, effective and convenient treatment opportunity for both patients and providers. We are looking forward to better understanding BPL-003 as an adjunctive therapy ahead of end-of-Phase II interactions with regulatory authorities, and we are thankful to the patients and study partners who have helped us reach this important milestone in our clinical development of BPL-003.”
The first part of this Phase IIa study investigating BPL-003 for Treatment Resistant Depression initially assessed the safety, tolerability, efficacy and pharmacokinetics of a single 10mg dose of BPL-003 alongside psychological support in patients with moderate-to-severe TRD who were not taking concomitant antidepressants. That part of the study was successfully completed in February 2024 and initial data showed that a single dose of BPL-003 rapidly induced an antidepressant response in 55% of patients the day after dosing (day 2). This effect was maintained, with 55% of patients in remission from depression at day 29 and 45% of patients in remission from depression at day 85. BPL-003 was also shown to require a short time in clinic with patients assessed as ready for discharge by the Investigators within an average time of less than 2 hours. These results indicate the potential of BPL-003 to deliver a scalable single dose treatment model that could fit within the existing treatment paradigm that has been successfully established by Spravato®.
A Phase IIb trial of BPL-003 is also currently underway and is evaluating the effects of a single medium or high dose of BPL-003 against a sub-perceptual dose in TRD patients who are not taking concomitant antidepressants. Initial results from that study are expected in H2 2024. The Phase IIb study received the U.S Food and Drug Administration’s (FDA) first ever Investigational New Drug (IND) approval for a Phase IIb clinical trial of a short-acting psychedelic last year and is thought to be the largest ever study to investigate 5-MeO-DMT in a clinical setting.
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 candidate currently under investigation for the treatment of 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-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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