NCT02436876

Study to Assess Safety and Clinical Activity of Local MBN-101 in Treatment of Infected Bone Sites

Completed Phase 2 Results posted Last updated 30 September 2021

What this trial tests

Phase 2 trial testing MBN-101 in Bacterial Infection in 29 participants. Completed in 26 July 2018.

Timeline

24 May 2016

Primary endpoint
27 October 2017

26 July 2018

Quick facts

Lead sponsor	Microbion Corporation
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	29
Start date	24 May 2016
Primary completion	27 October 2017
Estimated completion	26 July 2018
Sites	6 locations across United States

Drugs / interventions tested

• MBN-101 — full drug profile →
• Placebo

Conditions studied

• Bacterial Infection — all drugs for Bacterial Infection →

Sponsor

Microbion Corporation — full company profile →

Who can join

Adults 18 to 75, any sex, with Bacterial Infection. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Adverse Events Primary · 12 weeks

This study evaluates the safety and tolerability of single escalating doses of locally administered MBN-101 or placebo, as adjunct to standard of care antimicrobial and surgical therapy.

Safety: TEAEs

Group	Value	95% CI
MBN-101 0.5 µg/cm2	5
MBN-101 1.5 µg/cm2	4
MBN-101 5.0 µg/cm2	1
Placebo	6

Safety: Drug-related TEAEs

Group	Value	95% CI
MBN-101 0.5 µg/cm2	1
MBN-101 1.5 µg/cm2	1
MBN-101 5.0 µg/cm2	1
Placebo	1

Safety: SAEs

Group	Value	95% CI
MBN-101 0.5 µg/cm2	4
MBN-101 1.5 µg/cm2	2
MBN-101 5.0 µg/cm2	0
Placebo	3

Number of Treatment Failures Secondary · 12 weeks

Treatment failure is defined as clinical course requiring additional infection-related interventions including rehospitalization, additional surgery, or additional courses of systemic antibiotics.

Group	Value	95% CI
Cohort 1	1
Cohort 2	2
Cohort 3	1
Placebo	3

Treatment Failure in Subjects With Antibiotic-resistant Infections Secondary · Up to 12weeks

Treatment failure in subjects with baseline infections resistant to one or more antibiotics based on Central Laboratory Microbiological data

Group	Value	95% CI
Cohort 1	1
Cohort 2	2
Cohort 3	1
Placebo	2

Adverse events — posted to ClinicalTrials.gov

Time frame: 12 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

MBN-101 0.5 µg/cm2

Serious: 4/6 (67%)

Deaths: 0/6

MBN-101 1.5 µg/cm2

Serious: 2/6 (33%)

Deaths: 0/6

MBN-101 5.0 µg/cm2

Serious: 0/6 (0%)

Deaths: 0/6

Placebo

Serious: 3/7 (43%)

Deaths: 0/7

Serious adverse events (17 terms)

Reaction	System	MBN-101 0.5 µg/cm2	MBN-101 1.5 µg/cm2	MBN-101 5.0 µg/cm2	Placebo
Osteomyelitis	Infections and infestations	—	—	—	—
Acute kidney injury	Renal and urinary disorders	—	—	—	—
Cardiac failure	Cardiac disorders	—	—	—	—
Diabetic ketoacidosis	Metabolism and nutrition disorders	—	—	—	—
Myocardial ischemia	Cardiac disorders	—	—	—	—
Device failure	Product Issues	—	—	—	—
Tibia fracture	Musculoskeletal and connective tissue disorders	—	—	—	—
Wound dehiscence	Musculoskeletal and connective tissue disorders	—	—	—	—
Drug hypersensitivity	Product Issues	—	—	—	—
Serious injury	Injury, poisoning and procedural complications	—	—	—	—
Hematoma	Injury, poisoning and procedural complications	—	—	—	—
Bacterial sepsis	Infections and infestations	—	—	—	—
Deep vein thrombosis	Musculoskeletal and connective tissue disorders	—	—	—	—
C. difficile infection	Infections and infestations	—	—	—	—
Septic shock	Blood and lymphatic system disorders	—	—	—	—
Linear Immunoglobulin A disease	Blood and lymphatic system disorders	—	—	—	—
Road traffic accident	Injury, poisoning and procedural complications	—	—	—	—

Other adverse events (6 terms — click to expand)

Reaction	System	MBN-101 0.5 µg/cm2	MBN-101 1.5 µg/cm2	MBN-101 5.0 µg/cm2	Placebo
Infection	Infections and infestations	—	—	—	—
Gastrointestinal disorder	Gastrointestinal disorders	—	—	—	—
Osteomyelitis	Infections and infestations	—	—	—	—
Increased measurement of systemic C-reactive protein	Blood and lymphatic system disorders	—	—	—	—
Increased measurement of systemic red blood cell sedimentation rate	Blood and lymphatic system disorders	—	—	—	—
Blood alkaline phosphatase increased	Blood and lymphatic system disorders	—	—	—	—

Most-reported serious reactions: Osteomyelitis, Acute kidney injury, Cardiac failure, Diabetic ketoacidosis, Myocardial ischemia, Device failure, Tibia fracture, Wound dehiscence.

Data from ClinicalTrials.gov NCT02436876 adverse events section.

Sponsor's own description

This study evaluates the safety and clinical benefit of MBN-101 administered intraoperatively to osteosynthesis or osteomyelitis sites for patients diagnosed with an orthopedic infection, with or without orthopaedic hardware. Three quarters of the patients will receive MBN-101, while the other one quarter will receive placebo.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Antibiotics in the clinical pipeline in October 2019.
   Butler MS, Paterson DL. · · 2020 · cited 174× · PMID 32152527 · DOI 10.1038/s41429-020-0291-8
2. Antibiotics in the clinical pipeline as of December 2022.
   Butler MS, Henderson IR, Capon RJ, Blaskovich MAT. · · 2023 · cited 147× · PMID 37291465 · DOI 10.1038/s41429-023-00629-8
3. Implantable antimicrobial biomaterials for local drug delivery in bone infection models.
   Caplin JD, García AJ. · · 2019 · cited 67× · PMID 30654212 · DOI 10.1016/j.actbio.2019.01.015
4. Antibacterials with Novel Chemical Scaffolds in Clinical Development.
   Heimann D, Kohnhäuser D, Kohnhäuser AJ, Brönstrup M. · · 2025 · cited 10× · PMID 39847315 · DOI 10.1007/s40265-024-02137-x