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Leading BioSciences Announces Top Line Phase 2 Data Demonstrating LB1148 Achieves Primary Endpoint with Statistically Significant Improvement in Bowel Function Following Cardiovascular SurgeryCARLSBAD, Calif., March 24, 2020 (GLOBE NEWSWIRE) -- 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 clea 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 About Leading BioSciences Contact:
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