Leading BioSciences Announces Top Line Phase 2 Data Demonstrating LB1148 Achieves Primary Endpoint with Statistically Significant Improvement in Bowel Function Following Cardiovascular Surgery

Leading BioSciences Announces Top Line Phase 2 Data Demonstrating LB1148 Achieves Primary Endpoint with Statistically Significant Improvement in Bowel Function Following Cardiovascular Surgery

March 24, 2020

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Data Demonstrate Efficacy on an Approvable Endpoint That May Also Result in Substantial Cost Savings Based on Reductions ICU and Hospital Length of Stay

CARLSBAD, Calif., March 24, 2020 — Leading BioSciences, a drug development company focused on improving human health through therapeutic protection of the intestinal mucosal barrier, today announced top line Phase 2 data demonstrating its lead compound, 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 1.1-day reduction in average length of stay in the ICU and a 1.2-day reduction in average hospital length of stay. One of the primary factors in discharging patients from the hospital following surgery is the return of bowel function. Reductions in 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 $2,500 per day. LB1148 was also shown to be safe and well-tolerated in the study.

The Phase 2 clinical trial was a randomized, double-blind, parallel, placebo-controlled trial in 120 subjects undergoing coronary artery bypass grafting (CABG) and/or heart valve replacement surgery requiring cardiopulmonary bypass (CPB). Patients were randomized to receive LB1148 or placebo in conjunction with surgery. The trial’s primary endpoint was time to return of bowel function with LB1148 treatment as compared to placebo. ICU length of stay, hospital length of stay, organ function changes, inflammatory response and glucose control were secondary endpoints.

“These results are significant to the development of LB1148 as they add to the previously reported interim data to confirm a clean safety profile while also showing efficacy on an approvable endpoint. In addition, based on the positive readouts we have received from use of LB1148 in cardiovascular surgery, the company has also entered into a similar study to improve return of bowel function and reduce post-operative adhesions following gastrointestinal surgery,” said Tom Hallam, Ph.D., CEO of Leading BioSciences. “Further, while these results are not part of a head-to-head comparison trial, they do a demonstrate better improvement percentage than published data from an Entereg clinical trial in a similarly designed patient population, post-GI surgery. The strength of these trial results, combined with the clear need for innovative and safe therapeutics that can improve postoperative bowel function, strengthens our belief in the potential to expeditiously bring LB1148 to patients.”

“LB1148 has demonstrated the potential for measurable improvement in patient care following surgeries,” added Robert J. Trenschel, D.O., president and CEO of Yuma Regional Medical Center in Arizona. “I believe that a treatment such as LB1148 has the potential to be considered the standard of care for post-surgery patients, as it potentially leads to shorter recovery times, an important patient benefit, while reducing the length – and thereby the cost – of hospital stays.”

About LB1148
LB1148 is a patent-protected formulation of a broad-spectrum serine protease inhibitor designed to neutralize the activity of potent digestive proteases that can cause a range of serious complications and organ dysfunction if they escape the GI tract through a compromised mucosal barrier. By safely and effectively inhibiting the activity of digestive proteases, LB1148 has the potential to prevent damage to GI tissues, speed the return of GI function and shorten patients’ post-surgery stay in the ICU and hospital. This could substantially reduce the burden on the healthcare system, based upon the average cost of both ICU and hospital stays following cardiovascular surgery.

About Leading BioSciences
Leading BioSciences is developing novel therapeutics designed to improve human health through therapeutic protection of the Gastrobiome™. The Company’s initial focus is combatting the interruption of GI function (ileus) following major surgery to reduce recovery times and shorten patients’ length of stay in the hospital. Additionally, the company believes that its investigational therapies have the potential to prevent the formation of post-operative adhesions (reducing hospital re-admissions and additional surgeries), as well as to address the myriad of health conditions and complications associated with chronic disruption of the intestinal mucosal barrier. Learn more at: www.leadingbiosciences.com

JQA Partners, Inc.
Jules Abraham

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