Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BPL-003 · 4 trials · 3 indications
High compared to low dose of BPL-003. The MADRS is a 10-item diagnostic questionnaire used to measure the severity of depressive episodes in participants with mood disorders. A higher MADRS score indicates more severe depression, and each item yields a score of 0-6.
To determine the safety of a second dose of BPL-003 given with psychological support to participants with TRD as assessed by treatment-emergent adverse events.
The number (%) of participants with at least one treatment-emergent adverse event is presented. More detailed information is provided in the dedicated 'Adverse Events' section
The number (%) of participants with any clinically significant abnormal laboratory tests (routine haematology, clinical chemistry and coagulation) is presented
The number (%) of participants with any clinically significant abnormal vital signs (blood pressure, heart rate and temperature) result is presented
The C-SSRS was performed at screening, on Day 0 (dosing day), and on Days 1, 7, and 84 post-dose. Participants were counted if they answered 'yes' to any question. At baseline, the C-SSRS assessed the worst-point suicidal ideation experienced during the participant's lifetime. Beyond baseline, suicidal ideation and behaviour since last visit was assessed.
The RDQ was a brief assessment scale to ensure that ahead of discharge after BPL-003 dosing, participants: * Were fully responsive, aware of their surroundings, and reacted adequately * The acute psychedelic effects of the drug had completely subsided * Were fully orientated (name, location, time) * Had normal (or only slightly elevated) blood pressure and pulse rate, and normal breathing frequency and body temperature * Had a stable gate, normal muscle coordination, and could walk safely * Had only mild to moderate potential side affects that did not need to be medically monitored * Had no acute suicidal ideations or suicidal intentions * Possible distress or feelings of overwhelm had sufficiently subsided and the participant felt safe to be discharged. Readiness for discharge was assessed at 90 minutes post-dose and then every 30 minutes until the participant was deemed ready for discharge (eg, the answer was 'yes' to all of the above items).
The occurrence and (if applicable) frequency, emotional valence, and functional impact of any reactivation events was determined. To determine if reactivation had occurred, participants were asked if they had any flashbacks or recurrence of any effects of the study drug experience.
* Percentage of patients with treatment emergent adverse events * Percentage of patients with clinically significant abnormal laboratory tests * Percentage of patients with clinically significant abnormal vital signs * Percentage of patients with clinically significant findings in physical examination * Percentage of patients with clinically significant ECG parameters or cardiac telemetry abnormalities (Part 1 Arm B only) * Percentage of patients with suicidal ideation or behaviour
| Arm | Type | Description |
|---|---|---|
| Low dose | EXPERIMENTAL | Active placebo comparator |
| Medium dose | EXPERIMENTAL | - |
| High dose | EXPERIMENTAL | - |
| Monophasic | EXPERIMENTAL | - |
| Biphasic | EXPERIMENTAL | - |
| BPL-003 arm | EXPERIMENTAL | - |
| Arm A | EXPERIMENTAL | - |
| Arm B | EXPERIMENTAL | - |
| Placebo arm | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| BPL-003 | DRUG | A single dose administered intranasally |
| Placebo | OTHER | A single dose of placebo will be administered intranasally |
Inclusion Criteria: 1. At least moderate major depressive disorder. 2. Diagnosed with TRD defined as failure to respond to an adequate dose and duration of at least 2 pharmacological treatments based on the MGH ATRQ assessment. 3. Hamilton Depression Rating Scale score ≥19 at Screening and Baseline...
BPL-003 is an investigational small molecule being studied for psychiatric conditions, including treatment resistant depression and alcohol use disorder. It is also being evaluated in pharmacokinetic studies in healthy adults. BPL-003 is not approved and remains in clinical development.
BPL-003 targets the 5-HT2A receptor, a subtype of serotonin receptor. This receptor is the molecular target for the drug's mechanism of action in the central nervous system.
BPL-003 is being developed by AtaiBeckley Inc., a biopharmaceutical company. The company's stock is listed under the ticker symbol ATAI.
BPL-003 is in Phase 2 clinical development. It has completed a Phase 1 study and multiple Phase 2 studies, with one Phase 2 trial currently recruiting participants. The drug has not received FDA approval.
BPL-003 has been studied in several clinical trials. NCT05347849 was a completed Phase 1 single ascending dose study in healthy subjects. NCT05660642 is a recruiting Phase 2 open-label study in treatment resistant depression. NCT05674929 was a completed Phase 2 study in alcohol use disorder, and NCT05870540 was a completed Phase 2 efficacy and safety study in treatment resistant depression.
BPL-003 is also known by the name BPL003. It is a single investigational compound and is not the same as any other marketed drug.