SAN DIEGO, April 21, 2016 /PRNewswire/ -- Leading BioSciences Inc. today announced that the United States Patent and Trademark Office has granted a key patent covering the composition of its lead drug candidate LB1148, which is currently in Phase 2 clinical trials.
U.S. Patent No. 9,314,442 entitled "Compositions for the Treatment of Autodigestion" provides commercial rights in the United States through March 2035, which is in addition to the regulatory exclusivity that will be granted by the Food and Drug Administration. This patent covers a proprietary composition of tranexamic acid, polyethylene glycol, glucose and electrolytes.
"Having an issued U.S. patent for our lead drug LB1148 is a critical step in the development of this important therapeutic," said Clark Straw, CEO of Leading BioSciences. "The issued patent will protect this novel discovery and allow Leading BioSciences to maintain a leadership position as a protector of the intestinal mucosal barrier."
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 are approved compounds, having been used in hundreds of thousands of patients, and all have well-characterized and established safety profiles. The components of LB1148 are reconstituted in 700 milliliters of water prior to oral or enteral 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. Phase 2 clinical trials are underway for Leading BioSciences' investigational drug LB1148, which 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.
Chief Operating Officer, Leading BioSciences Inc.
Vice President, Canale Communications Inc.
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SOURCE Leading Biosciences Inc.