Patient Receives First Dose in Phase 2a Study of BPL-003 as SSRI Adjunct for TRD

The Phase 2a trial of BPL-003 is a clinical study that is currently underway to explore the efficacy of the drug as both a standalone treatment and in combination with SSRIs for patients suffering from Treatment Resistant Depression (TRD). The initial segment of the trial, which was completed in March 2024, demonstrated that BPL-003, when administered as a single dose, was safe and exhibited a quick-acting and long-lasting antidepressant effect, persisting for up to 12 weeks after administration.

The second phase of the study is now focusing on administering a single dose of BPL-003 to TRD patients who are already undergoing SSRI treatment. The first participant has received the dose, and preliminary findings are anticipated to be released in the first half of 2025.

atai Life Sciences, a biopharmaceutical firm that is publicly traded on NASDAQ and is focused on revolutionizing mental health treatment, announced the commencement of Part 2 of Beckley Psytech’s Phase 2a study. This study is a continuation of the investigation into BPL-003, an intranasal formulation of 5-MeO-DMT, as a potential treatment for TRD. The study, with the identifier NCT05660642, will include patients with moderate-to-severe TRD who are on a stable regimen of oral SSRIs. These patients will receive a single dose of BPL-003 along with psychological support. The study's objectives are to assess the safety, tolerability, efficacy, and pharmacological aspects of BPL-003 when used as an adjunct to SSRIs, with a follow-up period of 12 weeks post-dosing.

Florian Brand, CEO and Co-Founder of atai, highlighted the significance of this part of the study, noting that many trials involving psychedelics require participants to stop their current antidepressant medications. The results from this part of the study could provide valuable insights into the safety and efficacy of BPL-003 when used alongside SSRIs, potentially broadening patient access if the treatment is approved.

The first part of the Phase 2a study evaluated the effects of a single 10mg dose of BPL-003 with psychological support in TRD patients not taking other antidepressants. The data indicated that BPL-003 triggered a rapid antidepressant response in 55% of patients the day after dosing, with the effect being sustained at week 4 and continuing to week 12. Additionally, 55% of patients were in remission at week 4, and 45% at week 12. The drug was also noted for its short clinical duration, with acute effects resolving in less than two hours on average, suggesting the potential for a scalable single-dose treatment model.

Beckley Psytech, the developer of BPL-003, is a private biopharmaceutical company creating a novel, synthetic benzoate salt formulation of 5-MeO-DMT for intranasal delivery. This short-acting psychedelic compound is known to bind to various serotonergic receptors and has been associated with improvements in mood, anxiety, stress reduction, and increased life satisfaction and mindfulness.

atai, which made a strategic investment in Beckley Psytech in January 2024, holds a significant ownership stake and has agreed to collaborate on digital therapeutics and commercial activities in anticipation of potential future commercialization.

atai Life Sciences is dedicated to the development of innovative treatments for mental health disorders such as depression, anxiety, and addiction. The company's mission is to accelerate the development of new medicines that can bring about meaningful and lasting behavioral changes in mental health patients, with the ultimate goal of healing mental health disorders to enable everyone to live a more fulfilling life.