Leading BioSciences Receives FDA Clearance to Proceed with Phase 2 Clinical Trial of LB1148 for Ileus and Adhesions

SAN DIEGO, Sept. 7, 2016 /PRNewswire/ -- Leading BioSciences Inc. today announced that it has received clearance from the U.S. Food and Drug Administration to initiate the PROFILE study, a Phase 2 clinical trial of its lead drug candidate, LB1148, for post-operative ileus and abdominal adhesions. Post-operative ileus and adhesions are conditions that can result after abdominal surgery, often resulting in additional surgeries, extended hospital stays and higher medical costs. Roughly 20 million abdominal surgeries are performed in the U.S. every year.

The PROFILE study will help determine if LB1148, given prophylactically prior to surgery, can reduce the formation of adhesions and expedite the recovery time to normal gastrointestinal function following elective abdominal procedures, potentially leading to a new treatment option for two prevalent, painful and costly health issues.

"This IND clearance is a significant milestone for Leading BioSciences, as we build momentum toward demonstrating the broad therapeutic potential of LB1148," said Greg Doyle, CEO of Leading BioSciences. "This study is a major pillar of our three-trial approach to demonstrate efficacy of LB1148. We are now working diligently with our partners to prepare the PROFILE trial and begin recruiting patients."

In addition to the PROFILE trial, LB1148 is currently being evaluated in a Phase 2 clinical trial for post-surgical complications following cardiovascular shock. The company also plans to initiate an investigator-sponsored study of LB1148 in the third quarter for the treatment of severe shock. The investigational drug is designed to protect the intestinal lining, known as the mucosal barrier, which is believed to play a driving role in many widespread medical conditions.

The PROFILE trial is a randomized, double-blind, placebo-controlled Phase 2 study to evaluate LB1148 in approximately 120 patients. The study will evaluate the safety, efficacy and tolerability of LB1148 for the treatment of post-operative ileus and intra-abdominal adhesions in subjects undergoing elective bowel resection. The drug is taken orally 8 to 10 hours prior to surgery as part of the patient's bowel preparations. Additional information about this clinical trial is available at www.clinicaltrials.gov using identifier: NCT02836470.

About Postoperative Ileus and Adhesions

Postoperative ileus, a temporary impairment of gastrointestinal motility, is a leading cause of delay in return to normal bowel function after abdominal surgery. Patients who experience the condition typically require five additional days in the hospital.

Abdominal adhesions are bands of scar tissue that develop after approximately 95 percent of all abdominal surgeries, with up to 6 percent of cases requiring follow-up care. Every year, 400,000 individuals in the U.S. require surgical correction of abdominal adhesions, and nearly 30 percent of them will need yet another operation due to recurrence. Adhesions can cause bowel obstruction, are the leading cause of preventative infertility in women and a leading cause of postoperative pain.

About LB1148

LB1148 is a formulated, broad-spectrum serine protease inhibitor designed to preserve the intestine's mucosal barrier, thereby preventing the escape of potent digestive enzymes that can lead to acute shock, multiple organ failure, postoperative ileus, surgical adhesions and other conditions that currently have no or limited treatment options.

All of the components in the LB1148 formulation have approved uses in man, having been used in hundreds of thousands of patients. The components all have well-characterized and established safety profiles. LB1148 is reconstituted in water prior to oral administration, making the therapy suitable for use in a variety of clinical settings.

Leading BioSciences has an open Investigational New Drug application with the FDA for LB1148.

About Leading BioSciences Inc.

Leading BioSciences is a clinical-stage biopharmaceutical company advancing a novel therapeutic that addresses the breakdown of the intestinal mucosal barrier—a process believed to drive a range of serious health conditions in need of effective treatment options. With a deep and pioneering scientific understanding of this emerging area of biology, Leading BioSciences has developed a patented approach that can be applied to widespread conditions, including postoperative ileus, surgical adhesions, acute shock, and multiple organ failure. LB1148 will be evaluated in 2016 in a Phase 2 clinical trial for the treatment of postoperative ileus and surgical adhesions. Additional investigator initiated studies using LB1148 are planned in severe shock, beginning in the third quarter of 2016. The company's clinical development is supported by a robust base of positive preclinical outcomes and more than $22 million in foundational research backed by the National Institutes of Health. Visit www.leadingbiosciences.com for additional information.

SOURCE Leading BioSciences Inc.

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