Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company
that is reimagining therapeutic delivery, today provided guidance
on anticipated milestones during 2024.
“In 2023, we completed the transformation of the company,
focusing on strong execution which laid the foundation for
significant value inflection in the coming months,” said Adi
Mohanty, Chief Executive Officer of Biora Therapeutics.
“We begin 2024 in the clinic with our phase 1 study for BT-600,
which will be a major de-risking step in the development of our
NaviCap™ platform. We already have data on the device alone in
humans, and tofacitinib is already used to treat UC. In this study,
we combine the two. Based on our previous work, we know that
increased colon tissue concentration correlates with endoscopic
healing in UC patients, and we observed the NaviCap platform
achieve increased colon tissue concentration in animals. This
clinical study should provide critical data to help prove our
treatment hypothesis, setting the stage for a possible new
treatment paradigm for the treatment of GI-related diseases,”
continued Mr. Mohanty.
“The BioJet platform continues to exceed its performance targets
and shows outstanding promise to solve the challenges of oral
delivery of large molecules—the holy grail of drug delivery. We are
seeing increased interest in the platform as we generate additional
performance data with multiple molecules from collaborators,
including AstraZeneca and other large pharma companies, and we
expect to progress these relationships toward broad partnership
structures later this year, which could provide non-dilutive
funding for further development,” said Mr. Mohanty.
2024 Anticipated Milestones
NaviCap™ Targeted Oral Delivery Platform and BT-600 program in
ulcerative colitis
- Phase 1 SAD/MAD study data
for BT-600 in healthy volunteers. Initial data from the
SAD arm expected in 2-3 months, followed by MAD results including
tissue data.
- Potential phase 1B study in
UC patients. Developing study protocol with a goal to
generate data for BT-600 in ulcerative colitis patients ahead of
future phase 2 study.
- 56-day GLP tox study with
BT-600. Planned to begin in 2H 2024; enabling requirement
for larger and longer duration clinical studies.
BioJet™ Systemic Oral Delivery Platform development
- Progress with pharma
collaborations. Ongoing preclinical data generation
through animal studies with multiple collaborators’ molecules
anticipated throughout 2024. Anticipate expanding research
collaborations into development partnerships.
About the NaviCap™ Targeted Oral Delivery Platform and
BT-600Biora's NaviCap targeted oral therapeutics
platform utilizes a novel approach that could improve patient
outcomes by enabling delivery of therapeutics directly to the site
of disease, increasing 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. Research has shown that targeted
delivery of therapeutics has the potential to improve patient
outcomes in IBD.
The NaviCap platform uses an ingestible device designed for
targeted delivery of therapeutics to improve treatment of IBD. Once
swallowed, Biora’s proprietary GItrac™ autolocation technology
enables the device to autonomously identify targeted locations in
the GI tract and release a therapeutic dose of up to
500µl. Studies in healthy volunteers have
demonstrated accurate localization and delivery in a fasted
state and 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 (UC) also
demonstrated successful device performance in active UC
patients.
Biora’s BT-600 program is a drug/device combination designed to
use the NaviCap™ ingestible drug delivery device with a proprietary
liquid formulation of tofacitinib, for the potential treatment of
moderate to severe ulcerative colitis. The NaviCap device is orally
administered and has been designed for targeted therapeutic
delivery directly to the colon in this application. The company is
currently conducting a phase 1 clinical study with BT-600 in adult
healthy volunteers.
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 small
intestine 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 at
multi-milligram doses, without requiring complex reformulation.
Biora holds a comprehensive patent position for the BioJet
systemic oral delivery platform, with approximately 12 issued
patents and 29 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 clinical-stage 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 preclinical-stage 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 our anticipated milestones, the
progress and future expectations and goals of our research and
development and clinical efforts and research collaboration plans
and expectations are forward-looking statements. In some cases, you
can identify forward-looking statements by terms such as
“anticipate,” “may,” “might,” “will,” “objective,” “intend,”
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“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, clearance, or
acceptance of our clinical trials or 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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