An Open-Label, Single Dose Study to Evaluate the Safety, Tolerability and Pharmacodynamics of BPL-003 in Patients With Treatment Resistant Depression

• ClinicalTrials.gov Identifier: NCT05660642
• Recruitment Status: Recruiting
• First Posted: December 21, 2022
• Last Update Posted: February 6, 2024
• Sponsor: Beckley Psytech Limited
• Information provided by (Responsible Party): Beckley Psytech Limited

Tracking Information

• First Submitted Date: December 13, 2022
• First Posted Date: December 21, 2022
• Last Update Posted Date: February 6, 2024
• Actual Study Start Date: February 10, 2023
• Estimated Primary Completion Date: November 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 2, 2024)

To assess the safety and tolerability of a single intranasal dose of BPL-003 in patients with treatment resistant depression [ Time Frame: Baseline to 12 weeks post dose ]

• 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 (Arm B only)
• Percentage of patients with suicidal ideation or behavior

Original Primary Outcome Measures (submitted: December 13, 2022)

To assess the safety and tolerability of a single intranasal dose of BPL-003 in patients with treatment resistant depression [ Time Frame: Baseline to 12 weeks post dose ]

• 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
• Percentage of patients with suicidal ideation or behavior

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided

Current Other Pre-specified Outcome Measures (submitted: December 13, 2022)

• Change from Baseline in MADRS [ Time Frame: Day 2 to 12 weeks post dose ]
• Percentage of responders [ Time Frame: Day 2 to 12 weeks post dose ]
  Defined as 50% reduction in MADRS score compared to Baseline
• Percentage of patients in remission [ Time Frame: Day 2 to 12 weeks post dose ]
  Defined as MADRS score of <11
• Plasma levels of 5-MeO-DMT and its metabolite (bufotenine) [ Time Frame: Day 1 ]

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: An Open-Label, Single Dose Study to Evaluate the Safety, Tolerability and Pharmacodynamics of BPL-003 in Patients With Treatment Resistant Depression
• Official Title: An Open-Label, Phase 2a, Single Dose Study to Evaluate the Safety, Tolerability and Pharmacodynamics of BPL-003 in Patients With Treatment Resistant Depression
• Brief Summary: An open-label, multi-centre, Phase 2a study to evaluate the safety, tolerability, and pharmacodynamics of a single intranasal dose of BPL-003 combined with psychological support, in patients with treatment resistant depression when administered as monotherapy or as adjunctive therapy with defined SSRIs (citalopram, escitalopram, or sertraline).
• Detailed Description: Up to 52 patients, across 2 parallel arms (Arms A and Arms B) will receive one of two single doses of BPL-003, given intranasally, with 12 weeks of follow-up assessments. Psychological support will be given before, during and after dosing.
• Study Type: Interventional
• Study Phase: Phase 2

Study Design

Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description:

Open label

Masking: None (Open Label)
Primary Purpose: Treatment

• Condition: Treatment Resistant Depression

Intervention

Drug: BPL-003

Experimental BPL-003 arms: will investigate one of two doses of BPL-003

Study Arms

• Experimental: Arm A
  Intervention: Drug: BPL-003
• Experimental: Arm B
  Intervention: Drug: BPL-003

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: February 2, 2024): 52
• Original Estimated Enrollment (submitted: December 13, 2022): 12
• Estimated Study Completion Date: November 2024
• Estimated Primary Completion Date: November 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Diagnosed with Major Depressive Disorder.
2. Diagnosed with TRD defined as failure to respond to an adequate dose and duration of at least 2 pharmacological treatments.
3. Montgomery-Asberg Depression Rating Scale score ≥24 at Screening.
4. Clinical Global Impression - Severity ≥4 at Screening.
5. Willing and able to discontinue current pharmacological anti-depressant therapy.
6. On current stable dose of pharmacological antidepressant therapy limited to one of 3 SSRIs (arm B), i.e. either citalopram, escitalopram, or sertraline.

Exclusion Criteria:

1. Current or history of schizophrenia, psychotic disorder including psychotic depression, bipolar disorder, delusional disorder, schizoaffective disorder, or any other severe psychiatric disorder.
2. Current personality disorders.
3. First-degree family history of schizophrenia, bipolar disorder, delusional disorder, personality disorders or schizoaffective disorder.
4. Current alcohol or substance use disorder (other than caffeine or nicotine).
5. A participant who at any time, has been unresponsive to ketamine, esketamine, an adequate course of treatment with electroconvulsive therapy, or has received vagal nerve stimulation or deep brain stimulation.
6. Suicidal ideation with the intent to act or suicidal behavior within the 12 months prior to the start of Screening or on Day 1 prior to dosing.
7. Suicide attempt and/or self-injurious behavior within the last 12 months prior to Screening.
8. Uncontrolled medical conditions e.g. hypo/hyperthyroidism, diabetes, renal failure.
9. Seizure disorder or history of seizures (including febrile seizures).
10. Abnormal and clinically significant results on the physical examination, vital signs, electrocardiogram, or laboratory tests at Screening Baseline.
11. Any nasal obstruction, blockage, or symptoms of congestion at the time of dosing, that in the Investigator's opinion may interfere with administration of the study drug.
12. Currently receiving lithium, antipsychotics, serotonergic drugs (excluding the permitted SSRIs for arm B), psychostimulants, or any other prohibited medication.
13. Female patients who are pregnant or lactating, or of childbearing potential and not willing to use adequate forms of contraception.
14. Male patients who are sexually active and not willing to using adequate forms of contraception.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Beckley Psytech Ltd; +44 (0)1865 987633; Medinfo@beckleypsytech.com

• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT05660642
• Other Study ID Numbers: BPL-003-204
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: Due to the UK GDPR, individual participant data will not be shared publicly. Group data will be presented in publication after study completion.

• Current Responsible Party: Beckley Psytech Limited
• Original Responsible Party: Same as current
• Current Study Sponsor: Beckley Psytech Limited
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: VP & Head of Clinical Development, MD, PhD; Beckley Psytech Ltd

• PRS Account: Beckley Psytech Limited
• Verification Date: February 2024