LB1148

Our lead asset LB1148 is a novel oral liquid formulation of the well-characterized digestive enzyme inhibitor, tranexamic acid (“TXA”), with potential to both reduce abdominal adhesions and help restore bowel function following surgery. The therapy is being developed for administration prior to major surgeries that are at risk of disrupting the intestinal epithelial barrier.

One of the primary factors in discharging patients from the hospital following surgery is the return of bowel function. Reductions in the length of hospital stay have the potential to significantly reduce healthcare costs associated with cardiovascular surgery, as the national average for in-patient hospital expenses are estimated to be $2,400 per day.

Our initial focus is both combatting the interruption of GI function following major surgery to shorten patients’ length of stay in the hospital and reducing the incidence of post-surgical adhesions. Our ongoing clinical trial will provided data that supports LB1148's potential for both post-surgical return of bowel fuction as well as surgical adhesions.

Clinical Data Supporting LB1148:

Phase 2 data demonstrated that LB1148 provided a 30% improvement in the time to normal bowel function following cardiovascular surgery (p<0.001), compared to placebo. This improvement resulted in a 1.0-day reduction in average length of stay in the intensive care unit (ICU) and a 1.10-day reduction in average hospital length of stay. As a point of comparison, while there have been no head-to-head studies, the only currently approved treatment for improving recovery of GI function post-surgery demonstrated a lower percentage improvement in the time to return of bowel function following GI surgery. LB1148 was also generally safe and well-tolerated in the study.

As announced in March of 2020, a randomized, double-blind, parallel, placebo-controlled Phase 2 investigator-sponsored clinical trial of LB1148 in 120 patients undergoing coronary artery bypass grafting and/or heart valve replacement surgery requiring cardiopulmonary bypass was completed. Patients were randomized to receive LB1148 or placebo in conjunction with surgery. The trial’s primary endpoint was time to return of bowel function. Intensive Care Unit (“ICU”) length of stay, hospital length of stay, organ function changes, inflammatory response and glucose control were secondary endpoints. LB1148 provided an approximately 30% improvement in the time to normal bowel function following cardiovascular (“CV”) surgery (p<0.001) compared to placebo. The treatment group also had an average 1.10-day shorter length of stay in the ICU and an average 1.1-day shorter hospital stay. One of the primary factors in discharging patients from the hospital following surgery is the return of bowel function. LB1148 has been granted Fast Track designation from the U.S. Food and Drug Administration (“FDA”) for the treatment of postoperative GI dysfunction (which may present as feeding intolerance, ileus, necrotizing enterocolitis (“NEC”), etc.) associated with gut hypoperfusion injury in pediatric patients who have undergone congenital heart disease repair surgery.

LB1148 drug product formulation contains components, which are in approved marketed drugs and have been used in hundreds of thousands of patients. These components each possess well-characterized and established safety profiles, allowing for development through the 505(b)(2) regulatory pathway and may offer significantly expedited approval process with a high probability of success.

Understanding Postoperative Ileus & Post-Surgical Adhesions

An overview of potential near-term target indications for LB1148 include:

Accelerating return of bowel function after surgery

Slow return of bowel function is a common complication after many kinds of surgery and is often a rate-limiting step to patient discharge in addition to causing the patient uncomfortable abdominal discomfort. Annually in the United States alone, there are 1.1 million open heart surgeries in patients who may benefit from treatments to improve return of bowel function.

Post-Surgical Adhesions

Digestive enzymes can escape the intestine during major surgery and cause damage to the intestines and surrounding organs resulting in the formation of scar tissue known as adhesions. Adhesions can be painful and may prevent normal organ function, including that of the intestine, and are the leading cause of infertility in women. In some cases, adhesions require a second corrective surgical procedure. There are currently no therapeutics available to prevent or treat adhesions.