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Biora Therapeutics Provides Outlook for 2024SAN DIEGO, Jan. 16, 2024 (GLOBE NEWSWIRE) -- Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company that is reimagining therapeutic delivery, today provided guidance on anticipated milestones during 2024. “In 2023, we completed the transformation of the company, focusing on strong execution which laid the foundation for significant value inflection in the coming months,” said Adi Mohanty, Chief Executive Officer of Biora Therapeutics. “We begin 2024 in the clinic with our phase 1 study for BT-600, which will be a major de-risking step in the development of our NaviCap™ platform. We already have data on the device alone in humans, and tofacitinib is already used to treat UC. In this study, we combine the two. Based on our previous work, we know that increased colon tissue concentration correlates with endoscopic healing in UC patients, and we observed the NaviCap platform achieve increased colon tissue concentration in animals. This clinical study should provide critical data to help prove our treatment hypothesis, setting the stage for a possible new treatment paradigm for the treatment of GI-related diseases,” continued Mr. Mohanty. “The BioJet platform continues to exceed its performance targets and shows outstanding promise to solve the challenges of oral delivery of large molecules—the holy grail of drug delivery. We are seeing increased interest in the platform as we generate additional performance data with multiple molecules from collaborators, including AstraZeneca and other large pharma companies, and we expect to progress these relationships toward broad partnership structures later this year, which could provide non-dilutive funding for further development,” said Mr. Mohanty. 2024 Anticipated Milestones NaviCap™ Targeted Oral Delivery Platform and BT-600 program in ulcerative colitis
BioJet™ Systemic Oral Delivery Platform development
About the NaviCap™ Targeted Oral Delivery Platform and BT-600 The NaviCap platform uses an ingestible device designed for targeted delivery of therapeutics to improve treatment of IBD. Once swallowed, Biora’s proprietary GItrac™ autolocation technology enables the device to autonomously identify tareted locations in the GI tract and release a therapeutic dose of up to 500µl. 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. Biora’s BT-600 program is a drug/device combination designed to use the NaviCap™ ingestible drug delivery device with a proprietary liquid formulation of tofacitinib, for the potential treatment of moderate to severe ulcerative colitis. The NaviCap device is orally administered and has been designed for targeted therapeutic delivery directly to the colon in this application. The company is currently conducting a phase 1 clinical study with BT-600 in adult healthy volunteers. About the BioJet™ Systemic Oral Delivery Platform The BioJet platform uses an ingestible device designed to transit through the digestive system and activate in the small intestine, where liquid jets deliver drug directly into the small intestine for uptake into systemic circulation. The BioJet device is approximately the size of a multivitamin and is designed to autonomously deliver a wide range of large molecules, such as proteins, peptides, and nucleic acids, in liquid formulation at multi-milligram doses, without requiring complex reformulation. Biora holds a comprehensive patent position for the BioJet systemic oral delivery platform, with approximately 12 issued patents and 29 pending applications that cover its delivery platform and methods for using the platform to treat a disease or condition in a patient using liquid jet delivery of a wide range of drugs. About Biora Therapeutics Biora is focused on development of two therapeutics platforms: the clinical-stage 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 preclinical-stage 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 or follow the company on LinkedIn or Twitter. Safe Harbor Statement or Forward-Looking Statements Biora Therapeutics expressly disclaims any obligation to update any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law. Investor Contact Media Contact |