Trial Outcomes & Findings for Safety, Tolerability, and PK of LBP-EC01 in Patients With Lower Urinary Tract Colonization Caused by E. Coli (NCT NCT04191148)
NCT ID: NCT04191148
Last Updated: 2022-03-16
Results Overview
Safety and tolerability of LBP-EC01: Number of participants with treatment-related adverse events as assessed by DAIDS v2.1
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
36 participants
Primary outcome timeframe
35 days
Results posted on
2022-03-16
Participant Flow
Participant milestones
| Measure |
LBP-EC01
crPhage cocktail: at approximately 1.5 x 10\^10 to 3.0 x 10\^10 PFU/vial dosed BID by intraurethral administration
|
Placebo
Lactated Ringer's solution injection dosed BID by intraurethral administration
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
12
|
|
Overall Study
COMPLETED
|
22
|
12
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
LBP-EC01
crPhage cocktail: at approximately 1.5 x 10\^10 to 3.0 x 10\^10 PFU/vial dosed BID by intraurethral administration
|
Placebo
Lactated Ringer's solution injection dosed BID by intraurethral administration
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
2 participants in the experimental group (LBP-EC01) discontinued treatment early
Baseline characteristics by cohort
| Measure |
LBP-EC01
n=24 Participants
crPhage cocktail
LBP-EC01: crPhage cocktail
|
Placebo
n=12 Participants
Lactated Ringer's solution, injection, USP
Lactated Ringers Solution for Injection: Placebo
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.5 years
STANDARD_DEVIATION 16.36 • n=24 Participants
|
70.5 years
STANDARD_DEVIATION 14.37 • n=12 Participants
|
67.9 years
STANDARD_DEVIATION 15.64 • n=36 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=24 Participants
|
10 Participants
n=12 Participants
|
31 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=24 Participants
|
2 Participants
n=12 Participants
|
5 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=24 Participants
|
6 Participants
n=12 Participants
|
14 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=24 Participants
|
4 Participants
n=12 Participants
|
18 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=24 Participants
|
2 Participants
n=12 Participants
|
4 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
22 Participants
n=24 Participants
|
11 Participants
n=12 Participants
|
33 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
1 Participants
n=24 Participants
|
1 Participants
n=12 Participants
|
2 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska native
|
0 Participants
n=24 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
0 Participants
n=24 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=24 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
1 Participants
n=24 Participants
|
0 Participants
n=12 Participants
|
1 Participants
n=36 Participants
|
|
Baseline height (cm)
|
162.4 centimeters
STANDARD_DEVIATION 8.94 • n=22 Participants • 2 participants in the experimental group (LBP-EC01) discontinued treatment early
|
164.9 centimeters
STANDARD_DEVIATION 8.86 • n=12 Participants • 2 participants in the experimental group (LBP-EC01) discontinued treatment early
|
163.3 centimeters
STANDARD_DEVIATION 8.86 • n=34 Participants • 2 participants in the experimental group (LBP-EC01) discontinued treatment early
|
|
Baseline weight (kg)
|
79.39 kilograms
STANDARD_DEVIATION 16.555 • n=22 Participants • 2 participants in the experimental group (LBP-EC01) discontinued treatment early
|
73.04 kilograms
STANDARD_DEVIATION 9.446 • n=12 Participants • 2 participants in the experimental group (LBP-EC01) discontinued treatment early
|
77.15 kilograms
STANDARD_DEVIATION 14.616 • n=34 Participants • 2 participants in the experimental group (LBP-EC01) discontinued treatment early
|
|
Baseline body mass index (kg/m^2)
|
30.14 kilograms per meters squared
STANDARD_DEVIATION 5.908 • n=22 Participants • 2 participants in the control group (LBP-EC01) discontinued treatment early
|
26.90 kilograms per meters squared
STANDARD_DEVIATION 3.280 • n=12 Participants • 2 participants in the control group (LBP-EC01) discontinued treatment early
|
28.99 kilograms per meters squared
STANDARD_DEVIATION 5.316 • n=34 Participants • 2 participants in the control group (LBP-EC01) discontinued treatment early
|
|
Frequency of prior UTI in the last 12 months, n(%)
0
|
10 Participants
n=24 Participants
|
8 Participants
n=12 Participants
|
18 Participants
n=36 Participants
|
|
Frequency of prior UTI in the last 12 months, n(%)
1
|
12 Participants
n=24 Participants
|
2 Participants
n=12 Participants
|
14 Participants
n=36 Participants
|
|
Frequency of prior UTI in the last 12 months, n(%)
> 1
|
2 Participants
n=24 Participants
|
2 Participants
n=12 Participants
|
4 Participants
n=36 Participants
|
|
Frequency of prior UTI in last 1 month, n(%)
0
|
12 Participants
n=24 Participants
|
10 Participants
n=12 Participants
|
22 Participants
n=36 Participants
|
|
Frequency of prior UTI in last 1 month, n(%)
1
|
11 Participants
n=24 Participants
|
2 Participants
n=12 Participants
|
13 Participants
n=36 Participants
|
|
Frequency of prior UTI in last 1 month, n(%)
> 1
|
1 Participants
n=24 Participants
|
0 Participants
n=12 Participants
|
1 Participants
n=36 Participants
|
|
Prior antibiotic use (within 30 days of Screening), n(%)
Yes
|
4 Participants
n=24 Participants
|
0 Participants
n=12 Participants
|
4 Participants
n=36 Participants
|
|
Prior antibiotic use (within 30 days of Screening), n(%)
No
|
20 Participants
n=24 Participants
|
12 Participants
n=12 Participants
|
32 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: 35 daysPopulation: Safety Population
Safety and tolerability of LBP-EC01: Number of participants with treatment-related adverse events as assessed by DAIDS v2.1
Outcome measures
| Measure |
LBP-EC01
n=24 Participants
crPhage cocktail: at approximately 1.5 x 10\^10 to 3.0 x 10\^10 PFU/vial dosed BID by intraurethral administration
|
Placebo
n=12 Participants
Lactated Ringers Solution for Injection dosed BID by intraurethral administration
|
|---|---|---|
|
Number of Participants With Treatment-related Adverse Events as Assessed by DAIDS v2.1
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 28 daysPopulation: PK Population
Maximum concentration determined directly from the concentration-time profile
Outcome measures
| Measure |
LBP-EC01
n=24 Participants
crPhage cocktail: at approximately 1.5 x 10\^10 to 3.0 x 10\^10 PFU/vial dosed BID by intraurethral administration
|
Placebo
Lactated Ringers Solution for Injection dosed BID by intraurethral administration
|
|---|---|---|
|
Pharmacokinetics of LBP-EC01: Cmax
|
4600000 PFU/mL
Geometric Coefficient of Variation 37000
|
—
|
PRIMARY outcome
Timeframe: 28 daysPopulation: PK Population
Time to maximum concentration
Outcome measures
| Measure |
LBP-EC01
n=24 Participants
crPhage cocktail: at approximately 1.5 x 10\^10 to 3.0 x 10\^10 PFU/vial dosed BID by intraurethral administration
|
Placebo
Lactated Ringers Solution for Injection dosed BID by intraurethral administration
|
|---|---|---|
|
Pharmacokinetics of LBP-EC01: Tmax
|
2.19 hours
Geometric Coefficient of Variation 127.32
|
—
|
PRIMARY outcome
Timeframe: 28 daysPopulation: PK Population
Area under the concentration versus time curve from time 0 to the last measurable concentration
Outcome measures
| Measure |
LBP-EC01
n=24 Participants
crPhage cocktail: at approximately 1.5 x 10\^10 to 3.0 x 10\^10 PFU/vial dosed BID by intraurethral administration
|
Placebo
Lactated Ringers Solution for Injection dosed BID by intraurethral administration
|
|---|---|---|
|
Pharmacokinetics of LBP-EC01: AUC
|
13000000 h*PFU/ mL
Geometric Coefficient of Variation 69000
|
—
|
SECONDARY outcome
Timeframe: 28 daysPopulation: PD Population
The secondary objective of this study was to evaluate the pharmacodynamics (PD) of LBP-EC01 through reduction in urinary E.coli burden as defined by at least 1 log CFU reduction from baseline.
Outcome measures
| Measure |
LBP-EC01
n=21 Participants
crPhage cocktail: at approximately 1.5 x 10\^10 to 3.0 x 10\^10 PFU/vial dosed BID by intraurethral administration
|
Placebo
n=7 Participants
Lactated Ringers Solution for Injection dosed BID by intraurethral administration
|
|---|---|---|
|
Reduction in Urinary E.Coli Burden at Any of the Following Time Points: Day 2, Day 3, Day 5, Day 7 (EOT), Day 14 and Day 28
Day 2
|
11 Participants
|
2 Participants
|
|
Reduction in Urinary E.Coli Burden at Any of the Following Time Points: Day 2, Day 3, Day 5, Day 7 (EOT), Day 14 and Day 28
Day 3
|
8 Participants
|
2 Participants
|
|
Reduction in Urinary E.Coli Burden at Any of the Following Time Points: Day 2, Day 3, Day 5, Day 7 (EOT), Day 14 and Day 28
Day 5
|
10 Participants
|
4 Participants
|
|
Reduction in Urinary E.Coli Burden at Any of the Following Time Points: Day 2, Day 3, Day 5, Day 7 (EOT), Day 14 and Day 28
Day 7
|
9 Participants
|
3 Participants
|
|
Reduction in Urinary E.Coli Burden at Any of the Following Time Points: Day 2, Day 3, Day 5, Day 7 (EOT), Day 14 and Day 28
Day 14
|
8 Participants
|
5 Participants
|
|
Reduction in Urinary E.Coli Burden at Any of the Following Time Points: Day 2, Day 3, Day 5, Day 7 (EOT), Day 14 and Day 28
Day 28/ET
|
9 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 28 daysPopulation: PD Population
The secondary objective of this study was to evaluate the pharmacodynamics (PD) of LBP-EC01 through time to 1 logarithmic reduction in urinary E.coli count from baseline
Outcome measures
| Measure |
LBP-EC01
n=21 Participants
crPhage cocktail: at approximately 1.5 x 10\^10 to 3.0 x 10\^10 PFU/vial dosed BID by intraurethral administration
|
Placebo
n=7 Participants
Lactated Ringers Solution for Injection dosed BID by intraurethral administration
|
|---|---|---|
|
Time to 1 Logarithmic Reduction in Urinary E.Coli Count From Baseline
|
5.9 days
Standard Deviation 7.33
|
8.4 days
Standard Deviation 5.41
|
SECONDARY outcome
Timeframe: 28 daysPopulation: PD Population
The secondary objective of this study was to evaluate the pharmacodynamics (PD) of LBP-EC01 through recurrence of E.Coli colonization or incidence of infection based on clinical signs and symptoms
Outcome measures
| Measure |
LBP-EC01
n=21 Participants
crPhage cocktail: at approximately 1.5 x 10\^10 to 3.0 x 10\^10 PFU/vial dosed BID by intraurethral administration
|
Placebo
n=7 Participants
Lactated Ringers Solution for Injection dosed BID by intraurethral administration
|
|---|---|---|
|
Recurrence of E.Coli Colonization or Incidence of Infection Based on Clinical Signs and Symptoms
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 28 daysPopulation: Safety Population
The secondary objective of this study was to evaluate the pharmacodynamics (PD) of LBP-EC01 through changes in IgA
Outcome measures
| Measure |
LBP-EC01
n=24 Participants
crPhage cocktail: at approximately 1.5 x 10\^10 to 3.0 x 10\^10 PFU/vial dosed BID by intraurethral administration
|
Placebo
n=12 Participants
Lactated Ringers Solution for Injection dosed BID by intraurethral administration
|
|---|---|---|
|
Changes in Immunoglobulin (Ig)A
Baseline: (Patients with positive detection (>ULN))
|
2 participants
|
0 participants
|
|
Changes in Immunoglobulin (Ig)A
Day 28/ET: (Patients with positive detection (>ULN))
|
2 participants
|
2 participants
|
SECONDARY outcome
Timeframe: 28 daysPopulation: Safety Population
The secondary objective of this study was to evaluate the pharmacodynamics (PD) of LBP-EC01 through changes in IgE with a positive detection of \>100 IU/mL
Outcome measures
| Measure |
LBP-EC01
n=24 Participants
crPhage cocktail: at approximately 1.5 x 10\^10 to 3.0 x 10\^10 PFU/vial dosed BID by intraurethral administration
|
Placebo
n=12 Participants
Lactated Ringers Solution for Injection dosed BID by intraurethral administration
|
|---|---|---|
|
Changes in IgE
Baseline: Patients with positive detection (>ULN)
|
7 participants
|
3 participants
|
|
Changes in IgE
Day 28/ET: Patients with positive detection (>ULN)
|
8 participants
|
2 participants
|
SECONDARY outcome
Timeframe: 28 daysPopulation: Safety Population
The secondary objective of this study was to evaluate the pharmacodynamics (PD) of LBP-EC01 through changes in IgG with a positive detection of \>1600 mg/dL (\>16.0 g/L)
Outcome measures
| Measure |
LBP-EC01
n=24 Participants
crPhage cocktail: at approximately 1.5 x 10\^10 to 3.0 x 10\^10 PFU/vial dosed BID by intraurethral administration
|
Placebo
n=12 Participants
Lactated Ringers Solution for Injection dosed BID by intraurethral administration
|
|---|---|---|
|
Changes in IgG
Baseline: Patients with positive detection (>ULN)
|
1 participants
|
0 participants
|
|
Changes in IgG
Day 28/ET: Patients with positive detection (>ULN)
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 28 daysPopulation: Safety Population
The secondary objective of this study was to evaluate the pharmacodynamics (PD) of LBP-EC01 through changes in IgM with a positive detection \>230 mg/dL (\>2.3 g/L)
Outcome measures
| Measure |
LBP-EC01
n=24 Participants
crPhage cocktail: at approximately 1.5 x 10\^10 to 3.0 x 10\^10 PFU/vial dosed BID by intraurethral administration
|
Placebo
n=12 Participants
Lactated Ringers Solution for Injection dosed BID by intraurethral administration
|
|---|---|---|
|
Changes in IgM
Baseline: Patients with positive detection (>ULN)
|
0 participants
|
1 participants
|
|
Changes in IgM
Day 28/ET: Patients with positive detection (>ULN)
|
0 participants
|
0 participants
|
Adverse Events
LBP-EC01
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LBP-EC01
n=24 participants at risk
crPhage cocktail
LBP-EC01: crPhage cocktail
|
Placebo
n=12 participants at risk
Lactated Ringer's solution, injection, USP
Lactated Ringers Solution for Injection: Placebo
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
4.2%
1/24 • 35 days
|
0.00%
0/12 • 35 days
|
|
Infections and infestations
Coronavirus test positive
|
0.00%
0/24 • 35 days
|
8.3%
1/12 • 35 days
|
Other adverse events
| Measure |
LBP-EC01
n=24 participants at risk
crPhage cocktail
LBP-EC01: crPhage cocktail
|
Placebo
n=12 participants at risk
Lactated Ringer's solution, injection, USP
Lactated Ringers Solution for Injection: Placebo
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
8.3%
2/24 • 35 days
|
0.00%
0/12 • 35 days
|
|
Nervous system disorders
Headache
|
20.8%
5/24 • 35 days
|
0.00%
0/12 • 35 days
|
|
Nervous system disorders
Dizziness
|
8.3%
2/24 • 35 days
|
8.3%
1/12 • 35 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
3/24 • 35 days
|
0.00%
0/12 • 35 days
|
|
Renal and urinary disorders
Dysuria
|
8.3%
2/24 • 35 days
|
0.00%
0/12 • 35 days
|
|
Renal and urinary disorders
Hematuria
|
8.3%
2/24 • 35 days
|
0.00%
0/12 • 35 days
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/24 • 35 days
|
8.3%
1/12 • 35 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.2%
1/24 • 35 days
|
8.3%
1/12 • 35 days
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/24 • 35 days
|
8.3%
1/12 • 35 days
|
|
Renal and urinary disorders
Pollakiuria
|
8.3%
2/24 • 35 days
|
0.00%
0/12 • 35 days
|
|
Renal and urinary disorders
Bladder discomfort
|
0.00%
0/24 • 35 days
|
8.3%
1/12 • 35 days
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/24 • 35 days
|
16.7%
2/12 • 35 days
|
|
General disorders
Catheter site pain
|
0.00%
0/24 • 35 days
|
8.3%
1/12 • 35 days
|
|
Infections and infestations
Urinary tract infections
|
20.8%
5/24 • 35 days
|
0.00%
0/12 • 35 days
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
8.3%
2/24 • 35 days
|
0.00%
0/12 • 35 days
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/24 • 35 days
|
8.3%
1/12 • 35 days
|
|
Investigations
Spleen palpable
|
4.2%
1/24 • 35 days
|
8.3%
1/12 • 35 days
|
|
Investigations
Coronavirus test positive
|
0.00%
0/24 • 35 days
|
8.3%
1/12 • 35 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place