Treatment with BPL-003 comprises administration of BPL-003 in a clinical setting, with pre-dose preparation, in-dose safety monitoring and post-dose follow-up provided by healthcare professionals to support patients and ensure the safe use of the compound.Â
The BPL-003 treatment has been designed to overcome some of the challenges of first-generation psychedelics and existing mental health treatments and produce rapid, robust and lasting treatment effects with a short time in clinic of 2 hours.Â
Rapid, robust and lasting response from a single dose
Findings from an open-label Phase IIa study investigating 10mg of BPL-003 in patients with Treatment Resistant Depression (depression that failed to respond to two or more prior treatments) who were not taking concomitant antidepressants found that:
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.Â
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.
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