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Biora Therapeutics (formerly trading under the symbol BIOR) has generated frequent news coverage around its development of smart pill-based therapeutic delivery platforms and its corporate restructuring. Company releases describe Biora as a clinical-stage biotech focused on two main platforms: NaviCap, for colon-targeted treatment of inflammatory bowel disease, and BioJet, a swallowable autoinjector platform for oral delivery of large molecules designed to replace injection with needle-free, oral administration.
News items detail progress on the BioJet™ Oral Delivery Platform, including development of a smaller, 00-size device with increased payload capacity compared with a larger 000-size capsule. Biora reports that the 00-size BioJet device is designed to deliver standard liquid drug formulations with a capacity greater than 300 microliters and to enable doses greater than 50 milligrams. Releases also describe in vivo studies, work with collaborator molecules, and presentations at industry meetings such as the Partnership Opportunities in Drug Delivery meeting and the Peptide Therapeutics Symposium.
Another major theme in Biora’s news flow is the NaviCap™ platform and its application to inflammatory bowel disease. The company has announced Phase 1 clinical trial data for BT-600, a NaviCap-based program, presented at a leading gastroenterology conference and recognized with a Presidential Poster Award, with the results suggesting the potential for larger clinical trials in ulcerative colitis patients.
In addition to R&D updates, Biora’s news includes financing transactions, Nasdaq listing developments, and a chapter 11 filing in the District of Delaware as part of a court-supervised sale process. Subsequent news reports the completion of this restructuring, with Biora emerging as a privately held company and its existing common shares cancelled pursuant to a Plan of Reorganization. Readers following BIOR-related news can review this sequence of scientific, clinical, financial, and restructuring announcements to understand the company’s evolution and platform development.
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Biora Therapeutics (Nasdaq: BIOR) announced its participation in the IBD Innovate event on April 26, 2023, in New York City. The event will center on innovative product development in inflammatory bowel disease (IBD). Biora's Head of Strategy, Chris Wahl, will present on the NaviCap™ targeted oral delivery platform, which aims to enhance outcomes for ulcerative colitis patients by delivering therapies directly to disease sites, minimizing systemic toxicity.
The NaviCap device is an ingestible medical tool designed to autonomously release therapeutic doses in the gastrointestinal tract. Biora's BT-600 program uses this device to deliver a liquid formulation of tofacitinib for ulcerative colitis. Successful studies have demonstrated the device's localization capabilities and its potential as the first non-fasting ingestible delivery system. Biora aims to submit an IND application for Phase 1 trials.
Biora Therapeutics (Nasdaq: BIOR) provided a corporate update and financial results for the fourth quarter and full year ended December 31, 2022, announcing new brand names for its delivery platforms: NaviCap™ for oral delivery and BioJet™ for systemic delivery. The company achieved a significant milestone by completing a 14-day toxicology study for its BT-600 program, reporting no adverse events. Biora also announced impressive bioavailability results in preclinical studies, surpassing its target with an average of 37% for semaglutide and 51% for adalimumab. The company raised $12.9 million through its ATM program, while operating expenses decreased from the previous year.
Biora Therapeutics (Nasdaq: BIOR) will report its fourth quarter and full year financial results for the period ending December 31, 2022, on March 30, 2023, post-market close. A webcast and conference call will follow at 4:30 PM ET to discuss the results and provide corporate updates. Biora focuses on innovative therapeutic delivery solutions, including smart pills for targeted drug delivery and needle-free biotherapeutics. The company aims to enhance patient care through advanced therapeutic options.
Biora Therapeutics (Nasdaq: BIOR) announced promising preclinical data for its PGN-OB2 program, showcasing an average bioavailability of 37% for semaglutide, significantly higher than the current oral formulation's less than 1%. Utilizing liquid jet technology in porcine models, the results suggest strong potential for oral delivery of peptides and monoclonal antibodies. This aligns with the company’s goal of exceeding a 15% bioavailability target. With broad patent protection and a commitment to advancing their systemic delivery platform, Biora plans further preclinical studies in 2023 to enhance and commercialize this innovative delivery method.
Biora Therapeutics has announced promising preliminary results from its preclinical research on the PGN-OB1 program, demonstrating an average bioavailability of 51.3% for a variant of adalimumab, a result achieved using their novel liquid jet delivery technology. This marked improvement not only surpasses previous performance metrics but also shows consistent results comparable to traditional subcutaneous administration. The study evaluated a 56 mg dose in a porcine model, with the device expected to enhance future collaborations in the pharmaceutical sector. Biora possesses a robust patent portfolio with approximately 34 patents related to its delivery methods.