LB1148: An Enteral Protease Inhibitor Significantly Accelerated the Return of Bowel Function after Bowel Resection

Abstract

Introduction: Return of bowel function is a clinically accepted determinant of recovery after gastrointestinal (GI) surgery. Postoperative ileus presents significant clinical challenges that may prolong hospital stay, contribute to readmission, and increase morbidity and expense. The aim of this study was to determine if a novel enteral formulation of tranexamic acid, LB1148, could accelerate return of GI function in patients undergoing bowel resection surgery. Methods: We conducted a phase II multicenter, randomized, double-blind, placebo-controlled study of LB1148 for the restoration of postoperative bowel function in patients undergoing elective bowel resection. The study included both open and laparoscopic surgical approaches with anastomosis and or stoma creation. Primary outcome was recovery of bowel function as measured by time from end of surgery to oral food tolerance and passage of stool. Results: A total of 120 patients completed the study. Treatment groups were well balanced for patient demographics and included a broad range of baseline surgery characteristics, approaches, and methodologies. Median time to return of bowel function was 2.77 days vs 3.83 days in patients receiving LB1148 and placebo, respectively (hazard ratio=1.8; p = 0.0008). Key GI functional data will be presented based on laparoscopy and laparotomy with surgical characteristics including, right hemicolectomy, left hemicolectomy, and rectosigmoid surgery. The most common drug-related adverse events were GI disorders (LB1148 4.7% vs placebo 3.2%). No drug-related serious adverse events occurred in the trial. Conclusion: For patients undergoing elective bowel resection surgery, LB1148 was safe and well-tolerated and significantly accelerated the return of bowel function.