Positive Early Results for Beckley Psytech's 5-MeO-DMT Nasal Spray in TRD Trial

Beckley Psytech Ltd, a clinical-stage biopharmaceutical firm, has reported promising results from its Phase IIa clinical trial of BPL-003, a novel intranasal formulation of 5-MeO-DMT, for the treatment of Treatment Resistant Depression (TRD). The study found that a single 10mg dose of BPL-003 was well-tolerated and demonstrated a rapid and durable antidepressant effect. Notably, 55% of patients experienced an immediate response the day after treatment, and this remission rate was maintained with 55% of patients still in remission at day 29 and 45% at day 85.

The Phase IIa trial, which is an open-label study, involved 12 subjects with moderate-to-severe TRD who were not concurrently using antidepressants. The patients received a single dose of BPL-003 along with psychological support and were monitored for 12 weeks post-treatment. The rapid antidepressant response was measured using the Montgomery–Åsberg Depression Rating Scale (MADRS), with a response defined as a reduction of at least 50% in MADRS scores and remission as a MADRS score of 10 or less.

Importantly, BPL-003 was found to be generally well-tolerated with no serious adverse events reported. Mild or moderate events accounted for 95% of all occurrences, which aligns with the safety profile observed in Phase I studies. Additionally, the treatment duration was short, with patients being discharged on average within less than 2 hours after the acute effects had resolved. This suggests that BPL-003 could offer a more efficient treatment option compared to other psychedelic therapies in development, potentially reducing the burden on healthcare systems.

Beckley Psytech's ongoing Phase IIb study, which is the largest and only FDA-approved Phase IIb study of 5-MeO-DMT, is expected to provide topline data in the second half of 2024. The study will further evaluate the safety and efficacy of BPL-003 in 225 patients with TRD, comparing a medium or high dose against a sub-perceptual dose. The efficacy will be assessed using the MADRS scale at various points during an 8-week blinded follow-up period.

The initial findings from the Phase IIa study bolster confidence in the Phase IIb study and are expected to facilitate discussions with regulatory agencies regarding the development of BPL-003. Beckley Psytech is committed to advancing the treatment of TRD, a condition that affects approximately 33% of those living with depression and is characterized by a lack of response to standard antidepressant treatments.

With nearly 300 million people worldwide suffering from depression, and around 52 million in Europe and the US alone, the development of effective treatments like BPL-003 is crucial. The potential of BPL-003 to provide a rapid and durable antidepressant effect with a short treatment duration positions it as a significant advancement in the treatment of TRD.

Beckley Psytech, founded in 2019 and backed by over two decades of research from the Beckley Foundation, is dedicated to improving patient outcomes and easing the burden of neuropsychiatric conditions through the development of rapid-acting psychedelic medicines. The company's lead compound, BPL-003, is also under investigation for the treatment of Alcohol Use Disorder (AUD), and Beckley Psytech's second clinical asset, ELE-101, is being developed as a potential treatment for Major Depressive Disorder (MDD).