Study to Assess the Safety of MRx0029 or MRx0005 Compared to Placebo, in People With Parkinson's

NCT05832775 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: INNOVATE-LBP 1.0
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a first-in-human study to evaluate the safety and tolerability of repeat oral administrations of MRx0029 (20 participants) or MRx0005 (20 participants) in participants diagnosed with idiopathic PD. Participants who are successfully screened will be randomized to 1 of 2 treatment sequences (TS) within their cohort (10 participants per sequence). Each treatment period will be separated by a washout period of 4 to 6 weeks. Cohort A Treatment Sequence 1: MRx0029 (1 capsule bid) for 4 weeks; 4-to 6-week washout period; placebo (1 capsule bid) for 4 weeks. Cohort A Treatment Sequence 2: Placebo (1 capsule bid) for 4 weeks; 4-to 6-week washout period; MRx0029 (1 capsule bid) for 4 weeks. Cohort B Treatment Sequence 1 MRx0005 (1 capsule bid) for 4 weeks; 4- to 6-week washout period; placebo (1 capsule bid) for 4 weeks. Cohort B Treatment Sequence 2: Placebo (1 capsule bid) for 4 weeks; 4-to 6-week washout period; MRx0005 (1 capsule bid) for 4 weeks Cohort A will be randomized first and when all participants have been randomized to Cohort A, Cohort B enrollment will begin.

Conditions

Idiopathic Parkinson Disease

Keywords

Microbiome

Outcome Measures

Primary Outcomes (4)

• Incidence of treatment-emergent adverse events (TEAEs)

  Number of TEAEs after 4-weeks of treatment with MRx0029 vs 4-weeks of placebo in participants with idiopathic PD

  Baseline to Follow-up Visit (up to 24 weeks)

• Incidence of treatment-emergent adverse events (TEAEs)

  Number of TEAEs after 4 weeks of treatment with MRx0005 vs 4-weeks of placebo in participants with idiopathic PD

  Baseline to Follow-up Visit (up to 24 weeks)

• Incidence of Serious Adverse Events (SAEs)

  Number of SAEs after 4 weeks of treatment with MRx0029 vs 4-weeks of placebo in participants with idiopathic PD

  Baseline to Follow-up Visit (up to 24 weeks)

• Incidence of Serious Adverse Events (SAEs)

  Number of SAEs after 4 weeks of treatment with MRx0005 vs 4-weeks of placebo in participants with idiopathic PD

  Baseline to Follow-up Visit (up to 24 weeks)

Study Arms (4)

MRx0029 Treatment Sequence 1

EXPERIMENTAL

Patients will receive MRx0029 in the first treatment period and then placebo in the second treatment period

Biological: MRx0029

MRx0029 Treatment Sequence 2

EXPERIMENTAL

Patients will receive placebo in the first treatment period and then MRx0029 in the second treatment period

Biological: MRx0029

MRx0005 Treatment Sequence 1

EXPERIMENTAL

Patients will receive MRx0005 in the first treatment period and then placebo in the second treatment period

Biological: MRx0005

MRx0005 Treatment Sequence 2

EXPERIMENTAL

Patients will receive placebo in the first treatment period and then MRx0005 in the second treatment period

Biological: MRx0005

Interventions

MRx0029 BIOLOGICAL

Megasphaera massiliensis MRx0029 (Treatment A) and Placebo

MRx0029 Treatment Sequence 1; MRx0029 Treatment Sequence 2

MRx0005 BIOLOGICAL

Parabacteroides distasonis MRx0005 (Treatment B) and Placebo

MRx0005 Treatment Sequence 1; MRx0005 Treatment Sequence 2

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of idiopathic PD according to the UKPDS-BBCDC
• Able to understand and willing to provide informed consent and able to comply with the study procedures and restrictions.
• Male or female participants age ≥ 40 or ≤ 85 years of age.
• BMI ≥ 18.0 to ≤ 35.0 kg/m2, inclusive, where BMI (kg/m2) is calculated by body weight (kg)/height2 (m2).
• Hoehn \& Yahr (H\&Y) Stage I to II (if on levodopa the participant should be classed as Stage I to II in an 'ON' period)
• A documented diagnosis of PD
• If presently being medically treated for PD, they should be on a stable dose unchanged within the 30 days prior to screening and not be expected to require any adjustments or start any new PD medication for the duration of their participation in the study.
• No clinically relevant abnormal medical history, or abnormal findings on physical examination, vital signs, ECG, or laboratory tests
• Has been fully vaccinated with an approved Covid-19 vaccine
• Male and female participants are eligible to enter provided they follow the contraception criteria for the study.

You may not qualify if:

• Participants with significant motor fluctuations
• Parkinson syndromes
• Known carriers of familial PD genes
• History and/or current presence of clinically significant CNS disease other than PD.
• Montreal Cognitive Assessment (MoCA) \<24
• No history of spontaneous constipation since diagnosis
• Participants who are \<70% compliant to completing their e-daily assessed at Treatment Period 1, Day 1.
• Are non-compliant with prescribed PD medication
• Comorbidities that have not been optimally controlled for the last 3 months prior to screening.
• Participants with known Type 1 or Type 2 diabetes mellitus or a HbAlc result. indicative of diabetes/pre-diabetes.
• Have an active or recent malignant disease or any concomitant end-stage organ disease.
• Participants with known GI fistula, feeding tubes, or inflammatory bowel disease.
• Participants who had recent abdominal surgery (6 months before the screening visit).
• Participants with GI disease resulting in an inability to take oral medication, malabsorption syndrome, prior surgical procedures affecting absorption, uncontrolled GI disease
• Participants with conditions that may increase the risk of generalized peritonitis

Sponsors & Collaborators

• 4D pharma plc: lead
• Labcorp Corporation of America Holdings, Inc: collaborator
• ICON plc: collaborator

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2022
• First Posted: April 27, 2023
• Study Start: May 1, 2022
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: April 27, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share