Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Active
LB1148 · 1 trial · 2 indications
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).
| Arm | Type | Description |
|---|---|---|
| LB1148 | EXPERIMENTAL | Active |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| LB1148 | DRUG | A total of 700 mL of drug product will be administered orally as a split dose before surgery. |
| Placebo | DRUG | A total of 700 mL of placebo will be administered orally as a split dose before surgery. |
Inclusion Criteria: Subjects will be eligible for participation in the study only if they meet ALL of the following inclusion criteria: 1. Scheduled to undergo an elective (non-emergent) bowel resection with a planned stoma via laparotomy or minimally invasive technique. This includes any subject ...
LB1148 is an investigational small molecule developed by Palisade Bio, Inc. for ileus, a condition in which gastrointestinal motility is impaired after surgery. It is designed as a serine protease inhibitor and is being studied in patients undergoing bowel resection. LB1148 has completed a Phase 2 clinical trial and is not approved for commercial use.
LB1148 is being developed to support return of gastrointestinal function in patients with ileus, particularly following bowel resection surgery. The Phase 2 study also evaluated post-operative adhesions as a secondary condition. It is an investigational therapy and has not been approved for any indication.
LB1148 targets serine proteases, a class of enzymes involved in gastrointestinal function. By inhibiting serine protease activity, the drug is intended to help restore normal bowel motility after surgery. This mechanism is being investigated in the context of post-operative ileus and adhesions.
LB1148 is being developed by Palisade Bio, Inc., which trades on the Nasdaq under the ticker symbol PALI. The company is the sponsor of the clinical program evaluating LB1148 in gastrointestinal conditions, including ileus following bowel resection.
LB1148 is in Phase 2 development. A Phase 2 trial has been completed, and the drug remains investigational. It has not been approved by the FDA or any other regulatory agency for ileus or any other indication.
LB1148 has been studied in a completed Phase 2 trial, NCT02836470, titled a study to evaluate LB1148 for return of gastrointestinal function and adhesions in subjects undergoing bowel resection. The trial enrolled 112 participants in the United States and was randomized, double-blind, and placebo-controlled.