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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 being developed for ileus, a condition where the bowel fails to contract normally after surgery. It is also being studied for post-operative adhesions, which are bands of scar tissue that can form between abdominal tissues following bowel resection surgery.
LB1148 is being developed by Palisade Bio, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol PALI. The company is conducting clinical research to evaluate the drug's safety and efficacy in patients undergoing bowel resection.
LB1148 is in Phase 2 clinical development. It has completed one Phase 2 trial, and it remains an investigational drug that has not been approved by regulatory authorities. The completed study evaluated its effects on gastrointestinal function and adhesion formation in surgical patients.
LB1148 has one completed clinical trial, registered as NCT02836470, titled 'A Study to Evaluate LB1148 for Return of Gastrointestinal Function and Adhesions in Subjects Undergoing Bowel Resection.' This Phase 2 study enrolled 112 participants in the United States and was randomized, double-blind, and placebo-controlled.
No alternative names for LB1148 have been reported. The drug is identified solely by its code name LB1148 in clinical trial registrations and by its developer, Palisade Bio, Inc. No other brand or chemical names are associated with this investigational compound.