Leading BioSciences' GI drug reduces hospital stay after heart surgery

Leading BioSciences reported promising interim data from a phase 2 trial testing its serine protease inhibitor in patients undergoing cardiovascular surgery. The company is targeting postoperative ileus—the interruption of gastrointestinal function after surgery—to reduce a patient's recovery time and hospital stay.

The drug, LB1148, is designed to counteract the effects of digestive enzymes that "leak out" of the intestines and damage surrounding tissue. If left unchecked, these enzymes can lead to complications such as adhesions—in which organs that are not usually connected become bound by scar tissue—shock and multiple organ failure.

The ongoing phase 2 study involves 120 patients undergoing coronary artery bypass grafting and/or heart valve replacement surgery that requires cardiopulmonary bypass. They were randomized to receive LB1148 or placebo. The trial is looking to assess how LB1148 improves patients' postsurgical recovery, through measures including the time it takes to return to normal GI function (the primary endpoint), length of hospital stay and mortality rate.

The interim analysis, which will be presented "at a future medical meeting," found that treatment with LB1148 decreased patients' stay in the intensive care unit by 1.1 days and reduced their overall hospital stay by 3.2 days, compared to placebo. It also found that treated patients regained normal bowel function 18 hours sooner than patients who received placebo, the company said.

“[When] compared to the only treatment currently approved in the U.S. to improve postsurgery bowel function recovery, these data for LB1148 show a more rapid recovery of GI function, as well as significant administration and safety benefits," said Leading BioSciences CEO Tom Hallam, Ph.D., in a release. “We believe these results support the potential of LB1148 to address a key unmet medical need while providing dramatic cost savings for patients, hospitals and healthcare system."

Leading BioSciences is looking to tap into the 10 million surgeries performed in the U.S. each year that are at risk of postoperative ileus. The company also has a preclinical pipeline that targets the gut to treat various diseases, such as obesity, high cholesterol, hypertension, autism and insomnia.