Press Release Details

An average bioavailability of 37% for a GLP-1 receptor agonist was achieved in animals

SAN DIEGO, June 26, 2023 (GLOBE NEWSWIRE) -- Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company that is reimagining therapeutic delivery, today shared detailed results from its preclinical study titled “Evaluation of the Pharmacokinetics of Glucagon-Like-Peptide-1 (GLP-1) Receptor Agonist delivered through the BioJet™ Oral Biotherapeutic Delivery Platform in a Porcine Model,” which were presented during the American Diabetes Association (ADA) 83rd Scientific Sessions, held June 23–26, 2023 in San Diego, California.

“In this preclinical study, we assessed the bioavailability of semaglutide when delivered via our BioJet device in a porcine model. Following administration of semaglutide, the average oral bioavailability was 37%, ranging from 19% to 60% (CV: 40%). All dosed animals showed detectable drug levels up to ten days after administration,” said Sharat Singh, PhD, Head of Research at Biora Therapeutics. “We then conducted a second study, which also achieved an average bioavailability of 37%, demonstrating the repeatability of the results,” continued Dr. Singh.

Biora’s preclinical studies included a single dose of a liquid formulation of ~1 mg of semaglutide. Animals were dosed using the BioJet device, which was administered and activated endoscopically, as is typical in a porcine model, and blood sampling was performed from 0 to 240 hours post-dose, with comparison to a control animal with drug administered intravenously. The BioJet platform is designed to use needle-free, liquid jet injection to deliver drug into the small intestine for systemic absorption, with the potential to deliver almost any liquid drug, without requiring reformulation.

“Oral delivery of large molecules presents many challenges,” said Ariella Kelman, MD, Chief Medical Officer of Biora Therapeutics. “The bioavailability levels we have seen indicate that the BioJet platform could deliver proven, existing liquid drug formulations at doses similar to injection, without requiring reformulation or higher doses. These advantages of our technology represent the potential for substantial benefit for patients,” continued Dr. Kelman.

The poster presentation can be viewed on the American Diabetes Association website and is also available on the Biora Therapeutics website.

About the BioJet™ Systemic Oral Delivery Platform
Biora's BioJet systemic oral therapeutics platform uses an ingestible capsule for needle-free, oral delivery of large molecules designed to achieve systemic bioavailability and replace injection for better management of chronic diseases.

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 intestinal tissue 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 up to 400µL.

Biora is developing multiple molecules for delivery via the BioJet platform, including BT-002, a drug-device combination consisting of a variant of adalimumab delivered via the BioJet device for the treatment of inflammatory conditions, and BT-200, which consists of a GLP-1 receptor agonist delivered via the BioJet device for the treatment of type 2 diabetes. The company is currently advancing preclinical development of both programs.

Biora holds a comprehensive patent position for the BioJet systemic oral delivery platform, with approximately 34 patents and 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 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 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 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, 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