Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BPL-003 · 3 trials · 2 indications
The MADRS is a 10-item diagnostic questionnaire used to measure the severity of depressive episodes in participants with mood disorders. The MADRS was administered remotely throughout the trial by independent, centralized, qualified raters. The rater used the SIGMA to interview the participant, moving from broadly based questions about symptoms to more detailed questions that allowed the precise rating of symptom severity. The SIGMA provides structured probes to ensure standardization of administration and comprehensiveness of coverage of the 10 items of the scale. A higher MADRS score indicates more severe depression, with each item yielding a score of 0-6. Total overall scores therefore range from 0-60. The change from baseline in MADRS total score for 12 mg (high dose) vs 0.3 mg (low dose) BPL-003 at Day 29 was assessed.
The safety of a second dose of BPL-003 given with psychological support to participants with TRD was assessed by the number and percentage of participants with 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 (sub-therapeutic) | EXPERIMENTAL | Active placebo comparator |
| Medium dose | EXPERIMENTAL | - |
| High dose | EXPERIMENTAL | - |
| Monophasic | EXPERIMENTAL | - |
| Biphasic | EXPERIMENTAL | - |
| BPL-003 arm | EXPERIMENTAL | - |
| Arm A | EXPERIMENTAL | - |
| Arm B | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| BPL-003 | DRUG | A single dose administered intranasally |
Inclusion criteria: 1. Diagnosis of TRD. 2. History consistent with TRD. 3. Current depressive episode which is at least moderate in severity (Hamilton Depression Rating Scale score is ≥19 and Clinical Global Impression-Severity score is ≥4). 4. Willing and able to discontinue current antidepressan...
BPL-003 is an investigational small molecule being studied for Alcohol Use Disorder and Treatment Resistant Depression. It is in Phase 2 clinical development and has not been approved for any indication. Both conditions fall within psychiatry, and the program is being advanced by AtaiBeckley Inc.
BPL-003 targets the 5-HT2A receptor, also written 5-HT2AR, a serotonin receptor. Its target class is a receptor. This receptor activity is the basis for its investigation in psychiatric conditions such as Treatment Resistant Depression and Alcohol Use Disorder.
BPL-003 is being developed by AtaiBeckley Inc., which trades under the ticker ATAI. The company is advancing the small molecule through Phase 2 clinical development in psychiatry, with studies in Treatment Resistant Depression and Alcohol Use Disorder.
BPL-003 is in Phase 2 clinical development. It is investigational and has not been approved by the FDA or any other regulator. The program includes completed and recruiting Phase 2 studies in Treatment Resistant Depression and Alcohol Use Disorder.
BPL-003 has been studied in three Phase 2 trials. NCT05870540 evaluated efficacy and safety in Treatment Resistant Depression and is completed. NCT05674929 was an open-label single dose study in Alcohol Use Disorder and is completed. NCT05660642 is a recruiting open-label study in Treatment Resistant Depression.
Across its Phase 2 program, BPL-003 trials have enrolled a total of 268 participants. NCT05870540 enrolled 196 patients, NCT05660642 has a planned enrollment of 72, and NCT05674929 enrolled 13 patients with Alcohol Use Disorder.