Study to Assess Safety, Tolerability and Efficacy of Incremental Doses of MGB-BP-3 in Patients With CDAD

An Exploratory, Open Labelled, Phase IIa Study to Assess Safety, Tolerability and Efficacy of Incremental Doses of MGB-BP-3 in Patients With Clostridium Difficile-associated Diarrhea (CDAD)

The objective of this Phase IIa study is to assess the safety, tolerability, and efficacy of incremental doses of MGB-BP-3 in patients with Clostridium difficile-associated diarrhea (CDAD).

Study Overview

• Status: Completed
• Conditions: Clostridium Difficile Infection
• Intervention / Treatment: Drug: MGB-BP-3

Detailed Description

This is an exploratory, Phase IIa, open-label study assessing the safety, tolerability, and efficacy of incremental doses of MGB-BP-3 with 3 sequential groups of 10 patients with CDAD. Patients will be administered an oral dose of MGB-BP-3 for 10 days (Day 1 to Day 10). At the end of the treatment period, patients will be followed for up to 8 weeks to assess the incidence of disease recurrence.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 2T9
      • Foothills Medical Centre
• United States
  • Florida
    • Miami, Florida, United States, 33155
      • Florida International Medical Research
    • Orlando, Florida, United States, 32810
      • Omega Research Maitland LLC
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Snake River Research PLLC
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Clinic Foundation Infectious Disease Research
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Anne Arundel Medical Centre
  • Montana
    • Butte, Montana, United States, 59701
      • Mercury Street Medical Group PLLC
  • Texas
    • Houston, Texas, United States, 77084
      • Biopharma Informatic LLC
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Verity Research Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Main Inclusion Criteria:

1. Age 18 years or older of any gender.
2. Inpatients and/or outpatients who are able to attend all scheduled visits.
3. Patients with the first episode or the first recurrence of mild or moderate CDAD.
4. Confirmed diagnosis of mild or moderate CDAD as defined by the Infectious Diseases Society of America/Society for Healthcare Epidemiology of America guidelines.

Main Exclusion Criteria:

1. Patients with severe complicated CDAD (including hypotension or shock, ileus, megacolon, pseudomembranous colitis).
2. A white blood cell count higher than 15,000 cells/mL.
3. A serum creatinine level greater than or equal to 1.5 times ULN.
4. Elevated liver enzymes alanine aminotransferase and aspartate aminotransferase greater than ULN.
5. Inflammatory bowel disease (ulcerative colitis or Crohn's disease), microscopic colitis, or irritable bowel syndrome with chronic diarrhea.
6. Any other non-C difficile diarrhea.
7. Received treatment with a fecal transplant within 7 days and/or is anticipated to receive a fecal transplant during the study.
8. Major gastrointestinal surgery (ie, significant bowel resection) within 3 months of enrollment (does not include appendectomy or cholecystectomy).
9. Received laxatives within the previous 48 hours.
10. Pregnant or lactating women.
11. Prior (within 180 days of Screening) or current use of anti-toxin antibodies.
12. Have received a vaccine against C difficile.
13. Any condition for which, in the opinion of the investigator, the treatment may pose a health risk to the patient.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1: 125mg b.i.d. for 10 days; Patients will be administered an oral dose of 125mg b.i.d. MGB-BP-3 for 10 days (Day 1 to Day 10).	Drug: MGB-BP-3; MGB-BP-3; Other Names: No other names - not applicable
Active Comparator: Group 2: 250mg b.i.d. for 10 days; Patients will be administered an oral dose of 250mg b.i.d. MGB-BP-3 for 10 days (Day 1 to Day 10).	Drug: MGB-BP-3; MGB-BP-3; Other Names: No other names - not applicable
Active Comparator: Group 3: 500mg b.i.d. for 10 days; Patients will be administered an oral dose of 500mg b.i.d. MGB-BP-3 for 10 days (Day 1 to Day 10).	Drug: MGB-BP-3; MGB-BP-3; Other Names: No other names - not applicable

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with treatment-related adverse events assessed by the Investigator, as per CTCAE v.5.0.	Incidence of treatment emergent adverse events (Safety and Tolerability of up to 3 incremental doses of MGB-BP-3 in patients with CDAD).	40 days
Initial cure rate at 12 days post initiation of therapy.	Initial clinical cure is defined as resolution of diarrhea (<3 bowel movements with unformed stools within 24 hours [Type 5, 6, or 7 bowel movement on the Bristol Stool Chart] for patients for 2 consecutive days), maintained for the subsequent duration of therapy (1 day of exacerbation and then return to the resolved state is acceptable), with no further requirement for CDAD therapy, assessed by EOT and sustained for 2 days after the end of the 10-day initial treatment course.	12 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CDAD Recurrence	Recurrence of CDAD within 4 weeks (8 weeks optional) post end of treatment.	Up to 8 weeks
Peak plasma concentration (Cmax).	Days 1, 5 and 10.	10 days
Time to peak plasma concentration (Tmax).	Days 1, 5 and 10.	10 days

Collaborators and Investigators

• Sponsor: MGB Biopharma Limited
• Collaborators: Syneos Health
• Investigators: Study Director: Miroslav Ravic, MD, MGB Biopharma Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2019
• Primary Completion (Actual): April 3, 2020
• Study Completion (Actual): April 3, 2020

Study Registration Dates

• First Submitted: January 24, 2019
• First Submitted That Met QC Criteria: January 30, 2019
• First Posted (Actual): January 31, 2019

Study Record Updates

• Last Update Posted (Actual): April 15, 2020
• Last Update Submitted That Met QC Criteria: April 14, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Safety; Efficacy; Clostridium difficile; Tolerability; CDAD; Phase IIa; MGB-BP-3; Novel anti-infective
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Clostridium Infections
• Other Study ID Numbers: 1011464; 2015-000489-73 (EudraCT Number); 129507 (Other Identifier: FDA IND Number); MGB-BP-3-201 (Other Identifier: Syneos Health Protocol Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No