Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company that
is reimagining therapeutic delivery, today announced achievement of
its device performance targets for the company’s BioJet™ platform
for oral, systemic delivery of biotherapeutics, which uses an
ingestible device designed to achieve systemic uptake through
liquid jet delivery to the small intestine.
The company announced during its recent quarterly conference
call that it had preliminary results from animal testing indicating
achievement of both its device function targets and its performance
target of greater than or equal to 15% average bioavailability with
the autonomous version of its next-generation device. As planned,
the company subsequently conducted repeat studies and has now
confirmed the achievement of its development targets for the BioJet
platform.
“Achieving these performance targets in multiple animal studies
has enabled us to initiate testing the molecules of two of our
three pharma collaborators with our next-gen device, which is in
line with our stated goal to progress our collaborations and work
towards meaningful partnerships this year,” said Adi Mohanty, Chief
Executive Officer of Biora Therapeutics.
“While many organizations have been working to solve the
challenge of oral delivery of large molecules, our approach stands
out because of our ability to deliver essentially existing liquid
formulations with multi-milligrams per dose. Looking ahead to the
future of disease management, we think our BioJet platform will be
well positioned to deliver more complex molecules, such as dual and
triple agonists for diabetes management, monoclonal antibodies,
peptides, and other large molecules used for many complex diseases,
without the use of needles,” continued Mr. Mohanty.
In June, the company presented data generated with the BioJet
platform at the American Diabetes Association 83rd Scientific
Sessions, assessing the bioavailability of semaglutide delivered
via the BioJet device in an animal model. Biora will be presenting
more BioJet device-generated data in a short oral discussion at the
59th annual meeting of the European Association for the Study of
Diabetes, to be held October 2–6, 2023 in Hamburg, Germany.
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 holds a comprehensive patent position for the BioJet
systemic oral delivery platform, with approximately 11 issued
patents and 27 pending 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
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
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
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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 allowed patents or intended
grants to result in issued or granted patents, 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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