Beckley Psytech Begins Landmark Phase IIb Study on Novel Intranasal 5-MeO-DMT Formulation for Treatment Resistant Depression

LOS ANGELES- In a significant development for the field of neuropsychiatric treatment, Beckley Psytech Ltd, a leading clinical-stage biotechnology firm, announced today the initiation of its international Phase IIb study on BPL-003. This novel synthetic intranasal formulation of 5-MeO-DMT is being tested for its potential in treating Treatment Resistant Depression (TRD).

The study, a multi-centre and quadruply-masked Phase IIb trial, aims to assess the efficacy and safety of varying doses of BPL-003 among TRD patients. With this research being conducted at 40 sites spanning six countries—including Australia, Germany, Poland, Spain, the UK, and the US—it is considered the most extensive controlled study to examine 5-MeO-DMT.

Earlier this year, Beckley Psytech received the first-ever Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) for a Phase IIb study of a short-duration psychedelic compound. This study will evaluate the effects of medium and high doses of BPL-003, combined with psychological support, against an active placebo in a cohort of 225 patients diagnosed with moderate to severe TRD.

To ensure the credibility of the study and reduce expectancy bias, it will be conducted in a quadruply-masked manner. This means that the patient, investigator, therapist, and outcomes assessor will all be unaware of the subject’s dose allocation. Outcomes will be gauged using the Montgomery-Asberg Depression Rating Scale (MADRS) at various intervals throughout the trial. Additionally, all patients will receive psychological support before, during, and after dosing.

This Phase IIb trial was designed following Beckley Psytech’s earlier studies, which demonstrated that BPL-003 was well-tolerated and had a consistent pharmacokinetic profile. The selected dosages for this trial were proven to induce significant psychedelic experiences, manifesting treatment effects within minutes and concluding all perceptual effects within 60-90 minutes.

Fluence has been chosen as a partner by Beckley Psytech to facilitate training for the standardized psychological support that will be provided to trial participants. Results from this landmark study are anticipated by the end of 2024. Insights from this trial, combined with data from Beckley Psytech’s ongoing Phase IIa study of BPL-003 for TRD, will be pivotal in guiding the future clinical trajectory of the compound.

Cosmo Feilding Mellen, Beckley Psytech’s CEO, expressed his optimism about the trial, stating, “We’re proud to be at the forefront of discovering how short-duration psychedelics like 5-MeO-DMT can potentially address the immense challenges faced by countless individuals suffering from Treatment Resistant Depression globally.”

Dr. Rob Conley, Beckley Psytech’s Chief Scientific Officer, highlighted the global collaboration behind the study, thanking all contributors and emphasizing the significance of their joint efforts.

Beckley Psytech, established in 2019, remains devoted to enhancing the well-being of individuals afflicted with neuropsychiatric conditions by transforming psychedelics into licensed and effective medicines. Their mission is underpinned by over two decades of groundbreaking research from the Beckley Foundation, combining unparalleled psychedelic science with vast drug development expertise.

For more information, visit Beckley Psytech at www.beckleypsytech.com.