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Model LB1148 - Novel Oral Liquid Formulation
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.
Phase 2 data demonstrated that LB1148 provided a 30% improvement in the time to normal bowel function following cardiovascular surgery (p
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
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.
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.