Study overview

The open-label Phase IIa study investigated the safety, efficacy and pharmacokinetics of 10mg of BPL-003 in patients with Treatment Resistant Depression (TRD) who were not taking concomitant antidepressants. TRD was defined as a failure to respond to two or more pharmacological treatments within the current depressive episode.

Key findings

• A single administration of BPL-003 demonstrated a rapid antidepressant effect, with 55% of patients having a 50% or greater improvement in depression symptoms the day after dosing (day 2).
• A robust and lasting antidepressant effect was shown, with 55% of patients meeting the criteria for remission from symptoms of depression at day 29 and 45% in remission at day 85. 
• BPL-003 required a short time in clinic, with patients deemed dischargeable within an average time of less than 2 hours. This underlies the potential to deliver a scalable treatment model that, if approved, could fit within the existing interventional psychiatry treatment paradigm.

Study overview

The double-blind, placebo-controlled, single ascending dose study explored the safety, tolerability, pharmacokinetics and pharmacodynamics of BPL-003 treatment in 44 healthy volunteers. In the study, participants across 7 cohorts were given either a single dose of BPL-003 between 1 mg to 12 mg or a placebo. 

Key findings

• The study found that BPL-003 was safe and well-tolerated with no serious or severe adverse events reported. 
• BPL-003 was rapidly absorbed and eliminated, with 5‑MeO-DMT systemic exposure increasing approximately dose‑proportionally. 
• There was a reliable onset of subjective effects within minutes and these effects were resolved in less than 2 hours. 
• 87% of participants who received BPL-003 said they would accept the same or higher dose again, with 100% of participants who received the highest (12 mg) dose stating they would accept the same or higher dose again.