Biora Therapeutics Announces New Patent for its NaviCap Targeted Oral Delivery Platform

Biora Therapeutics, Inc. recently announced it received an Issue Notification from the US Patent and Trademark Office for a patent related to the treatment of gastrointestinal (GI) disorders through targeted delivery of JAK inhibitors for its NaviCap targeted oral delivery platform under development.

US Patent Application No. 17/313,339, titled Treatment of a Disease of the Gastrointestinal Tract with a JAK Inhibitor and Devices, will issue as US Patent No. 11,857,669 on January 2, 2024. The patent is directed to methods of treating a GI disease by delivering a therapeutically effective amount of a JAK inhibitor at a desired location in the GI tract, where the therapeutically effective amount of the JAK inhibitor is less than an amount that is effective when the JAK inhibitor is administered systemically. The patent covers many JAK inhibitors, including those that are approved or in development for a range of indications.

“This is another big IP win for us, as it encompasses the novel treatment paradigm of our BT-600 program, which is designed to use targeted delivery of a JAK inhibitor to potentially achieve better therapeutic effect in ulcerative colitis, at lower doses than those required with systemic delivery,” said Adi Mohanty, Chief Executive Officer of Biora Therapeutics. “We are eager to prove this out as we initiate our phase 1 trial for BT-600 shortly.”

The NaviCap ingestible device platform is protected by a patent portfolio consisting of 30 patent families, including 86 granted patents and 81 pending applications. Included in the NaviCap portfolio are 34 granted patents and 6 pending applications directed to the device’s proprietary autonomous localization technology and to various therapeutic targets for the treatment of inflammatory bowel disease, including, but not limited to, Janus kinases (JAK), TNF-alpha, integrins, chemokines, IL-12/23, S1P, and IL-10 inhibitors, and the delivery of antibodies, peptides, small molecules, nucleic acids, stem cells, bacterial yeast, or phages to the gastrointestinal tract. Biora’s total corporate portfolio consists of 73 patent families, including approximately 190 issued patents and 135 pending applications filed in major jurisdictions around the world, including the US, Europe, China, Japan, South Korea, Israel, Australia, Canada, and Mexico.

Biora’s NaviCap targeted oral therapeutics platform utilizes a novel approach that could improve patient outcomes by enabling delivery of therapeutics directly to the site of disease, increasing therapeutic levels in tissue while reducing systemic uptake. For the 1.8 million patients in the United States who suffer from inflammatory bowel disease (IBD), existing therapeutics offer less than ideal efficacy, likely because of the challenges with safely achieving sufficient drug levels in the affected tissues. Research has shown that targeted delivery of therapeutics has the potential to improve patient outcomes in IBD.

The NaviCap platform uses an ingestible device designed for targeted delivery of therapeutics to improve treatment of IBD. Once swallowed, Biora’s GItrac autolocation technology enables the device to autonomously identify targeted locations in the GI tract and release a therapeutic dose of up to 500 µl.

Biora’s BT-600 program consists of a unique, liquid formulation of tofacitinib delivered to the colon via the NaviCap device, for the treatment of ulcerative colitis. Studies in healthy volunteers have demonstrated accurate localization and delivery in a fasted state and demonstrated the device’s ability to function in both fasted and fed states, making it potentially the first ingestible therapeutic delivery device that does not require fasting or other food restriction for use. A device function study in participants with active ulcerative colitis (UC) also demonstrated successful device performance in active UC patients. The company recently received FDA clearance for its Investigational New Drug (IND) application to begin a phase 1 study for BT-600.

Biora Therapeutics is reimagining therapeutic delivery. By creating innovative smart pills designed for targeted drug delivery to the GI tract, and systemic, needle-free delivery of biotherapeutics, the company is developing therapies to improve patients’ lives. Biora is focused on development of two therapeutics platforms: the NaviCap™ targeted oral delivery platform, which is designed to improve outcomes for patients with inflammatory bowel disease through treatment at the site of disease in the gastrointestinal tract, and the BioJet™ systemic oral delivery platform, which is designed to replace injection for better management of chronic diseases through needle-free, oral delivery of large molecules. For more information, visit bioratherapeutics.com.