First Patient Dosed In Psychedelics Therapy Study For Treatment-Resistant Depression

Private psychedelics medicine company Beckley Psytech Ltd announced this week 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 its proprietary intranasal formulation of synthetic 5-MeO-DMT for treatment-resistant depression (TRD.)

“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," stated Dr. Rob Conley, chief scientific and medical officer at Beckley Psytech. "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. "

See Also: Atai Invests $50M In Beckley Psytech For Short-Duration Psychedelics Development

Study Highlights

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 Selective Serotonin Reuptake Inhibitors (SSRIs) in this study.

In this part of the study patients with moderate-to-severe TRD who are also taking certain defined SSRIs will receive a single dose of BPL-003 alongside psychological support 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 the first half of 2025. 

Part 1 of the study was in patients who were not taking antidepressants with initial results showing that a single dose of BPL-003 was safe and well-tolerated, with a rapid and durable antidepressant effect lasting up to 85 days post-dose.

A Phase IIb trial of BPL-003 is also currently underway, 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 the second half of the year. 

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