Leading BioSciences Inc. announced that the United States Patent and Trademark Office issued a Notice of Allowance for a patent application covering the composition of its lead drug candidate, LB1148.
US Patent Application No. 13,825,779, entitled "Administration of Serine Protease Inhibitors to the Stomach," has claims directed to compositions containing tranexamic acid, polyethylene glycol and electrolytes. The patent granted from this application will provide exclusivity in the US through 2031, further strengthening the existing patents for LB1148 that are scheduled to expire in 2034.
"This allowed patent application provides additional composition-of-matter IP protection for our lead therapeutic," said Greg Doyle, CEO of Leading BioSciences. "Through the efforts of our internal IP team, led by John Rodenrys, executive director of R&D and Dr. Tom Hallam, senior vice president of Clinical and Regulatory Affairs, we continue to strengthen the company's intellectual property position. This, in turn, will support long product exclusivity and revenue growth."
LB1148 is currently being evaluated in a phase 2 clinical trial for post-surgical complications following cardiovascular shock. Leading BioSciences plans to initiate an additional phase 2 clinical trial of LB1148 for the treatment of postoperative ileus and surgical adhesions before the end of the year, and an investigator-sponsored study of LB1148 for the treatment of severe shock is planned for the third quarter of 2016.
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.