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Patent Advances for Gut Damage Treatment Delivery

U.S. Patent and Trademark Office

U.S. Patent and Trademark Office in Alexandria, Virginia (A. Kotok)

10 August 2016. A developer of therapies for damage to an intestinal barrier received a notice that the U.S. intends to issue a patent protecting the technology to deliver the treatments. Leading Biosciences Inc. in San Diego said today it received a notice of allowance from the U.S. Patent and Trademark Office for its application to protect part of the intellectual property behind the technology.

Leading Biosciences is developing therapies for damage to the intestinal wall, particularly the mucosal barrier that holds in digestive enzymes. When the mucosal barrier is compromised, the escaping enzymes can cause severe damage to other organs leading to shock. These problems can occur after abdominal surgery, when ileus, or normal contractions of the intestinal wall fail to occur, or when unwanted adhesions or bands of scar tissue develop over intestinal tissue.

The company’s lead product, code-named LB1148 limits the actions of proteases, a class of enzymes that break down proteins and peptides, damaging to the mucosal barrier in the intestine. The company’s basic technology is based in part on research in the lab of Geert Schmid-Schönbein at University of California in San Diego, and a scientific adviser to Leading Biosciences.

In April 2016, Leading Biosciences received a patent on the composition of LB1148, while the notice of allowance indicates the patent office believes the company has met the requirements, and the agency intends to issue a new patent. The additional patent will protect an extension of the technology for delivering the protease inhibitors directly to the stomach, via a tube inserted through the nose through the esophagus, or a catheter. The application also covers administration of oral drugs. Geert Schmid-Schönbein is listed as one of the inventors.

Leading Biosciences is planning an intermediate stage clinical trial testing LB1148 among 120 adults scheduled to undergo elective bowel resection surgery. The participants will be randomly assigned to receive LB1148 treatments or a placebo, with the time needed for gastrointestinal functions to return as the main measure of efficacy. Recruitment has not yet begun for the trial.

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