SAN DIEGO, Oct. 24, 2022 (GLOBE NEWSWIRE) -- 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.
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Managing Director, LifeSci Advisors