Biora Therapeutics to Participate in Crohn’s & Colitis Foundation’s IBD Innovate Conference
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.
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SAN DIEGO, April 20, 2023 (GLOBE NEWSWIRE) -- Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company that is reimagining therapeutic delivery, today announced that it will participate in IBD Innovate: Product Development for Crohn’s & Colitis, an event hosted by the Crohn’s & Colitis Foundation to showcase innovative product development programs in inflammatory bowel disease (IBD), which will take place in New York City on April 26, 2023.
Biora’s Head of Strategy and Business Development, Chris Wahl, MD, MBA, will present a session titled “Colonic Delivery of Therapies by a Novel Ingestible Medical Device.” The presentation will focus on Biora’s NaviCap™ targeted oral delivery platform currently under development, which is designed to improve patient outcomes in ulcerative colitis by increasing the available dose at the site of disease while reducing systemic toxicity.
About the NaviCap™ Targeted Oral Delivery Platform and BT-600
Biora's NaviCap targeted oral therapeutics platform utilizes a novel approach that could improve IBD 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. It is approximately the size of a fish oil capsule and delivers a payload of up to 500µl liquid or solid formulation. Once swallowed, the device is designed to autonomously identify specific locations in the GI tract and release a therapeutic dose.
Biora’s BT-600 program consists of a 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 plans to submit an Investigational New Drug (IND) application to begin a Phase 1 study with its BT-600 program to evaluate drug concentration in tissue and plasma.
About Biora Therapeutics
Biora Therapeutics is the biotech company that 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 design 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 or follow the company on LinkedIn or Twitter.
Safe Harbor Statement or Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, including statements concerning the progress and future expectations and goals of our research and development and clinical efforts, are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “plan,” “target,” or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements reflect our plans, estimates, and expectations, as of the date of this press release. These statements involve known and unknown risks, uncertainties and other factors that could cause our actual results to differ materially from the forward-looking statements expressed or implied in this press release. Such risks, uncertainties, and other factors include, among others, our ability to innovate in the field of therapeutics, our ability to make future filings and initiate clinical trials on expected timelines or at all, our ability to obtain and maintain regulatory approval or clearance of our products on expected timelines or at all, our plans to research, develop, and commercialize new products, the unpredictable relationship between preclinical study results and clinical study results, our expectations regarding opportunities with current or future pharmaceutical collaborators, our ability to raise sufficient capital to achieve our business objectives, the ongoing COVID-19 pandemic, and those risks described in “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the year ended December 31, 2022 filed with the SEC and other subsequent documents, including Quarterly Reports, that we file with the SEC.
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
Chuck Padala
Managing Director, LifeSci Advisors
IR@bioratherapeutics.com
(646) 627-8390
Media Contact
media@bioratherapeutics.com
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