Study overview

The open-label Phase IIa study investigated the safety, efficacy and pharmacokinetics of a single dose of BPL-003 in 12 patients with moderate-to-severe depression who had failed to respond to at least two or more prior treatments of depression and were taking defined SSRIs. Patients were followed for 12 weeks post-dosing, with assessments conducted at multiple points throughout the study.

Key findings

• A single dose of BPL-003 induced rapid antidepressant effect, with a mean MADRS (Montgomery-Asberg Depression Rating Scale) reduction of 18 points from baseline observed the day after dosing.
• This antidepressant effect was long-lasting, with a mean MADRS reduction of 19 points from baseline observed one month after dosing and a mean MADRS reduction of 18 points from baseline observed three months after dosing.
• BPL-003 was shown to be well-tolerated. All adverse events were mild or moderate in severity and there were no serious adverse events (SAEs) reported. 
• Acute effects resolved on the day of dosing, with patients deemed dischargeable within an average time of less than two hours. 

Study overview

The open-label Phase IIa study evaluated the safety, tolerability, subjective effects and efficacy of a single intravenous (IV) dose of ELE-101 in 6 patients diagnosed with MDD, commonly known as depression.

Key findings

• A single dose of ELE-101, delivered via a 10 minute infusion, induced a rapid and clinically significant antidepressant response in the majority of patients, with these effects sustained in the 4 subjects evaluable at 3 months. 
• There was a 25 point mean reduction in MADRS scores seen the day after dosing, and 4/6 subjects had MADRS scores of 10 or less (considered as remission) immediately the day after dosing. 
• A >20 point reduction in MADRS scores was also observed at all time points through to 3 months after dosing, with all 4 subjects evaluable at day 90 after dosing meeting the remission criteria.
• ELE-101 was well-tolerated with mostly mild, transient adverse events and no serious or severe adverse events reported. 
• ELE-101 also demonstrated a short treatment duration, with acute effects resolving and patients deemed ready to be discharged by Investigators within a mean time of approximately 2 hours. This supports the potential for ELE-101 to fit within the interventional psychiatric treatment model that is currently in place for Spravato®.

Study overview

The open-label Phase IIa study, which took place at King’s College London and Clerkenwell Health in the UK, investigated the safety, tolerability, pharmacodynamic effects and impact on alcohol use of a single dose of BPL-003 - when given in combination with relapse prevention cognitive behavioural therapy - in 12 patients diagnosed with moderate-to-severe Alcohol Use Disorder.

Key findings

• The mean number of alcohol units per day decreased from 9.3 in the 12 weeks prior to dosing to 2.2 at the end of the study (12 weeks post-dosing). 
• The mean percentage of Heavy Drinking Days dropped from 56% in the pre-dose period to 13% at the end of the study.
• The mean number of abstinent days increased from 33% in the pre-dose period to 81% at the end of the study. 
• 50% of participants remained completely abstinent during the 12-week follow-up period following a single dose.
• BPL-003 was shown to be well-tolerated with adverse events (AEs) being reported as mild or moderate and there were no serious or severe adverse events reported. 
• Most patients were also assessed as ready for discharge within approximately 2 hours. 

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.