Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company that is reimagining therapeutic delivery, today announced the five posters presented at the American College of Gastroenterology (ACG) 2022 Annual Scientific Meeting, which is being held in Charlotte, NC and virtually from October 21–26, 2022.

At the ACG meeting, the company presented detailed results from two human trials for its targeted therapeutics platform that were performed first in healthy patients and subsequently in active ulcerative colitis patients. In posters titled “A scintigraphic study to evaluate the safety, tolerability, and functionality of a Drug Delivery System (DDS) device in healthy volunteers in fasted state” and “A scintigraphic study to evaluate the localization and delivery function of a Drug Delivery System (DDS) device in patients with active ulcerative colitis (UC) in fasted state,” researchers found that the DDS device was well tolerated and functioned as intended in autonomously identifying colon entry and releasing a radioactive payload in the colon.

In the poster titled “Pilot study to assess pharmacokinetic and pharmacodynamic markers following enema-dosing with adalimumab in patients with active ulcerative colitis (UC),” researchers at Mater Hospital Brisbane, Royal Adelaide Hospital, and Biora Therapeutics assessed pharmacokinetic and pharmacodynamic parameters following dosing with an adalimumab enema in patients with active UC, to evaluate whether topical treatment with adalimumab may be beneficial for treatment of UC.

Biora Therapeutics also presented two posters presenting preclinical data on its systemic therapeutics platform, titled “Development of ex-vivo and in-vivo models to assess the performance of an oral biotherapeutic delivery system (OBDS) device” and “Evaluation of the pharmacokinetics of PGN-OB1 following oral administration of an oral biotherapeutics delivery system (OBDS) in Yucatan swine.”

All five posters can be viewed by visiting bioratherapeutics.com/publications. 

About Biora Therapeutics’ Targeted Therapeutics Platform    
Biora Therapeutics’ targeted therapeutics platform utilizes a novel approach that could improve IBD patient outcomes by enabling delivery of therapeutics directly to the site of disease. The objective is to increase 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. Recent data have shown that targeted delivery of therapeutics has the potential to improve patient outcomes in IBD.    
   
Biora’s Drug Delivery System (DDS) is an ingestible capsule 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 capsule is designed to autonomously identify specific locations in the GI tract and release a therapeutic dose.

Biora is developing the PGN-600 program, which consists of a liquid formulation of tofacitinib delivered to the colon via the DDS capsule, for the treatment of ulcerative colitis. Studies in healthy volunteers have demonstrated accurate localization and delivery in a fasted state and also 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 also demonstrated successful device performance in active UC patients.    

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 envisions a world where patients have access to needle-free drug delivery and better therapeutic outcomes.

For more information, visit bioratherapeutics.com or follow the company on LinkedIn or Twitter.

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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 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” 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 precision medicine, risks related to the supply and manufacturing of and complexity of components in our devices, 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 future revenue generating opportunities with current or future pharmaceutical collaborators, our ability to raise sufficient capital to achieve our business objectives, the ongoing COVID-19 pandemic, competition from other companies, 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, 2021 filed with the SEC and other subsequent documents, including Quarterly Reports, that we file with the SEC.

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Investor Contact
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(646) 627-8390

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