Trial Outcomes & Findings for A Study to Evaluate LB1148 for Return of Gastrointestinal Function and Adhesions in Subjects Undergoing Bowel Resection (NCT NCT02836470)

Last Updated: 2024-06-21

Results Overview

Extent and severity of intra-abd. adhesions will be determined by the surgeon using the "Intra-Abdominal Adhesion Extent and Severity Assessment Worksheet" with a min. value of zero (0) (better) and a max. value of one hundred and eight (108) (worse). And which records four (4) Sub scores for nine (9) abd. regions which are all summed to make the Total Extent and severity score. Sub scores include: 1) Abd. Wall to Bowel Extent Score (0-3); 2) Abd. Wall to Bowl Severity Score (0-3); Bowel to Bowel (or Viscera) Extent Score (0-3); Bowel to Bowel (or Viscera) Severity Score (0-3); The nine (9) Abd. Regions include: Right upper; Epigastrium; Left upper; Left flank; Left lower; Pelvis; Right lower; Right flank; and Central. Each Sub score is scored with a min. value of zero (0) (better) and a max. value of three (3) (worse); 0=no adhesion; 1=min. (\<1/3 of the site is covered); 2=mod. (1/3 to 2/3 of the site is covered); 3=extensive (\>2/3 of the site is covered).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

112 participants

Primary outcome timeframe

up to 8 months from the index surgery

Results posted on

2024-06-21

Participant Flow

Participant milestones

Participant milestones
Measure	LB1148 Active LB1148: A total of 700 mL of drug product was administered orally as a split dose before surgery.	Placebo Placebo Placebo: A total of 700 mL of placebo was administered orally as a split dose before surgery.
Overall Study STARTED	57	55
Overall Study COMPLETED	52	49
Overall Study NOT COMPLETED	5	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Evaluate LB1148 for Return of Gastrointestinal Function and Adhesions in Subjects Undergoing Bowel Resection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LB1148 n=57 Participants Active LB1148: A total of 700 mL of drug product was administered orally as a split dose before surgery.	Placebo n=55 Participants Placebo Placebo: A total of 700 mL of placebo was administered orally as a split dose before surgery.	Total n=112 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	36 Participants n=5 Participants	36 Participants n=7 Participants	72 Participants n=5 Participants
Age, Categorical >=65 years	21 Participants n=5 Participants	19 Participants n=7 Participants	40 Participants n=5 Participants
Age, Continuous	59.4 years STANDARD_DEVIATION 11.56 • n=5 Participants	55.9 years STANDARD_DEVIATION 13.94 • n=7 Participants	57.6 years STANDARD_DEVIATION 12.85 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	24 Participants n=7 Participants	48 Participants n=5 Participants
Sex: Female, Male Male	33 Participants n=5 Participants	31 Participants n=7 Participants	64 Participants n=5 Participants
Race/Ethnicity, Customized White/Caucasian	52 participants n=5 Participants	49 participants n=7 Participants	101 participants n=5 Participants
Race/Ethnicity, Customized Black	3 participants n=5 Participants	3 participants n=7 Participants	6 participants n=5 Participants
Race/Ethnicity, Customized Asian	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity, Customized American Indian	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Pacific Islander	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity, Customized Other	1 participants n=5 Participants	2 participants n=7 Participants	3 participants n=5 Participants
Region of Enrollment United States	57 participants n=5 Participants	55 participants n=7 Participants	112 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 8 months from the index surgery

Population: The protocol from July 11 '16 underwent 6 amendments. The Safety Population included all randomized subjects (n=112). The modified Intention to Treat (mITT) population comprised subjects meeting criteria and receiving full dose with no key deviations (n=33). Those completing per protocol (PP) were (n=22). The smaller evaluable populations for Outcome Measures vs. Safety Population are due to Second Surgery completion requirements.

Outcome measures

Outcome measures
Measure	LB1148 n=11 Participants Active LB1148: A total of 700 mL of drug product was administered orally as a split dose before surgery.	Placebo n=11 Participants Placebo Placebo: A total of 700 mL of placebo was administered orally as a split dose before surgery.
Change From Baseline in Extent and Severity of Intra-abdominal Adhesions Among Subjects Treated With LB1148 or Placebo Minimally Invasive Approach	20.3 total extent and severity scores Standard Deviation 23.77	4.3 total extent and severity scores Standard Deviation 5.87
Change From Baseline in Extent and Severity of Intra-abdominal Adhesions Among Subjects Treated With LB1148 or Placebo Laparotomy Approach	4.0 total extent and severity scores Standard Deviation NA not applicable as there was only 1 subject (LB1148) in this group	8.5 total extent and severity scores Standard Deviation 9.19

Adverse Events

LB1148

Serious events: 16 serious events

Other events: 38 other events

Deaths: 2 deaths

Placebo

Serious events: 14 serious events

Other events: 40 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	LB1148 n=57 participants at risk Active LB1148: A total of 700 mL of drug product was administered orally as a split dose before surgery.	Placebo n=55 participants at risk Placebo Placebo: A total of 700 mL of placebo was administered orally as a split dose before surgery.
Metabolism and nutrition disorders Hypokalaemia	8.8% 5/57 • Adverse event data was collected from first administration of study drug through initial hospital discharge, or early termination, whichever came first. Following discharge through the second surgery visit, if applicable, any hospital readmissions were collected. Any serious adverse event or adverse event related to the second surgery was also collected from Day 0 to Month 3 ±1 Month.	1.8% 1/55 • Adverse event data was collected from first administration of study drug through initial hospital discharge, or early termination, whichever came first. Following discharge through the second surgery visit, if applicable, any hospital readmissions were collected. Any serious adverse event or adverse event related to the second surgery was also collected from Day 0 to Month 3 ±1 Month.
Metabolism and nutrition disorders Hypomagnesaemia	5.3% 3/57 • Adverse event data was collected from first administration of study drug through initial hospital discharge, or early termination, whichever came first. Following discharge through the second surgery visit, if applicable, any hospital readmissions were collected. Any serious adverse event or adverse event related to the second surgery was also collected from Day 0 to Month 3 ±1 Month.	0.00% 0/55 • Adverse event data was collected from first administration of study drug through initial hospital discharge, or early termination, whichever came first. Following discharge through the second surgery visit, if applicable, any hospital readmissions were collected. Any serious adverse event or adverse event related to the second surgery was also collected from Day 0 to Month 3 ±1 Month.
Renal and urinary disorders Acute kidney injury	1.8% 1/57 • Adverse event data was collected from first administration of study drug through initial hospital discharge, or early termination, whichever came first. Following discharge through the second surgery visit, if applicable, any hospital readmissions were collected. Any serious adverse event or adverse event related to the second surgery was also collected from Day 0 to Month 3 ±1 Month.	5.5% 3/55 • Adverse event data was collected from first administration of study drug through initial hospital discharge, or early termination, whichever came first. Following discharge through the second surgery visit, if applicable, any hospital readmissions were collected. Any serious adverse event or adverse event related to the second surgery was also collected from Day 0 to Month 3 ±1 Month.
Renal and urinary disorders Urinary retention	8.8% 5/57 • Adverse event data was collected from first administration of study drug through initial hospital discharge, or early termination, whichever came first. Following discharge through the second surgery visit, if applicable, any hospital readmissions were collected. Any serious adverse event or adverse event related to the second surgery was also collected from Day 0 to Month 3 ±1 Month.	1.8% 1/55 • Adverse event data was collected from first administration of study drug through initial hospital discharge, or early termination, whichever came first. Following discharge through the second surgery visit, if applicable, any hospital readmissions were collected. Any serious adverse event or adverse event related to the second surgery was also collected from Day 0 to Month 3 ±1 Month.
Blood and lymphatic system disorders anemia	5.3% 3/57 • Adverse event data was collected from first administration of study drug through initial hospital discharge, or early termination, whichever came first. Following discharge through the second surgery visit, if applicable, any hospital readmissions were collected. Any serious adverse event or adverse event related to the second surgery was also collected from Day 0 to Month 3 ±1 Month.	3.6% 2/55 • Adverse event data was collected from first administration of study drug through initial hospital discharge, or early termination, whichever came first. Following discharge through the second surgery visit, if applicable, any hospital readmissions were collected. Any serious adverse event or adverse event related to the second surgery was also collected from Day 0 to Month 3 ±1 Month.
Gastrointestinal disorders Dyspepsia	0.00% 0/57 • Adverse event data was collected from first administration of study drug through initial hospital discharge, or early termination, whichever came first. Following discharge through the second surgery visit, if applicable, any hospital readmissions were collected. Any serious adverse event or adverse event related to the second surgery was also collected from Day 0 to Month 3 ±1 Month.	5.5% 3/55 • Adverse event data was collected from first administration of study drug through initial hospital discharge, or early termination, whichever came first. Following discharge through the second surgery visit, if applicable, any hospital readmissions were collected. Any serious adverse event or adverse event related to the second surgery was also collected from Day 0 to Month 3 ±1 Month.
Gastrointestinal disorders Gastrooesophageal reflux disease	7.0% 4/57 • Adverse event data was collected from first administration of study drug through initial hospital discharge, or early termination, whichever came first. Following discharge through the second surgery visit, if applicable, any hospital readmissions were collected. Any serious adverse event or adverse event related to the second surgery was also collected from Day 0 to Month 3 ±1 Month.	0.00% 0/55 • Adverse event data was collected from first administration of study drug through initial hospital discharge, or early termination, whichever came first. Following discharge through the second surgery visit, if applicable, any hospital readmissions were collected. Any serious adverse event or adverse event related to the second surgery was also collected from Day 0 to Month 3 ±1 Month.
Gastrointestinal disorders Vomiting	8.8% 5/57 • Adverse event data was collected from first administration of study drug through initial hospital discharge, or early termination, whichever came first. Following discharge through the second surgery visit, if applicable, any hospital readmissions were collected. Any serious adverse event or adverse event related to the second surgery was also collected from Day 0 to Month 3 ±1 Month.	10.9% 6/55 • Adverse event data was collected from first administration of study drug through initial hospital discharge, or early termination, whichever came first. Following discharge through the second surgery visit, if applicable, any hospital readmissions were collected. Any serious adverse event or adverse event related to the second surgery was also collected from Day 0 to Month 3 ±1 Month.
Infections and infestations Pneumonia	5.3% 3/57 • Adverse event data was collected from first administration of study drug through initial hospital discharge, or early termination, whichever came first. Following discharge through the second surgery visit, if applicable, any hospital readmissions were collected. Any serious adverse event or adverse event related to the second surgery was also collected from Day 0 to Month 3 ±1 Month.	0.00% 0/55 • Adverse event data was collected from first administration of study drug through initial hospital discharge, or early termination, whichever came first. Following discharge through the second surgery visit, if applicable, any hospital readmissions were collected. Any serious adverse event or adverse event related to the second surgery was also collected from Day 0 to Month 3 ±1 Month.
Injury, poisoning and procedural complications Postoperative ileus	7.0% 4/57 • Adverse event data was collected from first administration of study drug through initial hospital discharge, or early termination, whichever came first. Following discharge through the second surgery visit, if applicable, any hospital readmissions were collected. Any serious adverse event or adverse event related to the second surgery was also collected from Day 0 to Month 3 ±1 Month.	14.5% 8/55 • Adverse event data was collected from first administration of study drug through initial hospital discharge, or early termination, whichever came first. Following discharge through the second surgery visit, if applicable, any hospital readmissions were collected. Any serious adverse event or adverse event related to the second surgery was also collected from Day 0 to Month 3 ±1 Month.
Injury, poisoning and procedural complications Procedural pain	10.5% 6/57 • Adverse event data was collected from first administration of study drug through initial hospital discharge, or early termination, whichever came first. Following discharge through the second surgery visit, if applicable, any hospital readmissions were collected. Any serious adverse event or adverse event related to the second surgery was also collected from Day 0 to Month 3 ±1 Month.	7.3% 4/55 • Adverse event data was collected from first administration of study drug through initial hospital discharge, or early termination, whichever came first. Following discharge through the second surgery visit, if applicable, any hospital readmissions were collected. Any serious adverse event or adverse event related to the second surgery was also collected from Day 0 to Month 3 ±1 Month.
Gastrointestinal disorders nausea	21.1% 12/57 • Adverse event data was collected from first administration of study drug through initial hospital discharge, or early termination, whichever came first. Following discharge through the second surgery visit, if applicable, any hospital readmissions were collected. Any serious adverse event or adverse event related to the second surgery was also collected from Day 0 to Month 3 ±1 Month.	21.8% 12/55 • Adverse event data was collected from first administration of study drug through initial hospital discharge, or early termination, whichever came first. Following discharge through the second surgery visit, if applicable, any hospital readmissions were collected. Any serious adverse event or adverse event related to the second surgery was also collected from Day 0 to Month 3 ±1 Month.
General disorders pyrexia	3.5% 2/57 • Adverse event data was collected from first administration of study drug through initial hospital discharge, or early termination, whichever came first. Following discharge through the second surgery visit, if applicable, any hospital readmissions were collected. Any serious adverse event or adverse event related to the second surgery was also collected from Day 0 to Month 3 ±1 Month.	5.5% 3/55 • Adverse event data was collected from first administration of study drug through initial hospital discharge, or early termination, whichever came first. Following discharge through the second surgery visit, if applicable, any hospital readmissions were collected. Any serious adverse event or adverse event related to the second surgery was also collected from Day 0 to Month 3 ±1 Month.

Additional Information

Mitchell Jones, CMO

Palisade Bio

Phone: 858-704-4900

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place