FDA Releases LB1148 for Phase II Trial in Averting Abdominal Surgery Complications

Leading BioSciences received IND clearance from FDA to begin a Phase II study of LB1148, for post-operative ileus and abdominal adhesions, which can result after abdominal surgery, and often require additional surgeries and extended hospital stays.

The investigational drug is designed to protect the intestinal lining. The study will help determine if LB1148, given prior to surgery, can reduce the formation of adhesions and expedite the recovery time to normal gastrointestinal function following elective abdominal procedures. The company is now preparing to enroll approximately 120 patients.

LB1148 is also being evaluated in a Phase II clinical trial for post-surgical complications following cardiovascular shock.