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
PlatformBiora'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 TherapeuticsBiora 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
StatementsThis 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
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including statements concerning the progress and future
expectations and goals of our research and development and clinical
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identify forward-looking statements by terms such as “may,”
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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 ContactChuck PadalaManaging Director,
LifeSci AdvisorsIR@bioratherapeutics.com(646) 627-8390
Media Contactmedia@bioratherapeutics.com
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