Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company that
is reimagining therapeutic delivery, today announced progress with
its latest clinical device performance study, evaluating the device
function and safety of its NaviCap™ targeted oral delivery
platform.
“In this study evaluating twelve subjects to date, the NaviCap
device accurately identified entry into the colon, triggered
release of its non-drug payload, and achieved distribution
throughout the colon in all subjects,” said Sharat Singh, PhD, Head
of Research at Biora Therapeutics. “Importantly, we observed no
early or late deployments,” continued Dr. Singh.
The NaviCap platform uses an ingestible device designed for
targeted delivery of therapeutics to improve treatment of IBD. Once
swallowed, Biora’s GItrac™ autolocation technology enables the
device to autonomously identify targeted locations in the GI tract
and release its payload.
“We are continuing to see excellent device performance in human
studies with the NaviCap platform, following similar results in
three previous functional studies in both healthy volunteers and
patients with active ulcerative colitis,” said Ariella Kelman, MD,
Chief Medical Officer of Biora Therapeutics. “With more than 40
study participants receiving over 70 NaviCap devices to date, the
combined results build confidence as we proceed toward an IND
application in the third quarter of this year for our BT-600
program for treatment of ulcerative colitis,” continued Dr.
Kelman.
Biora’s BT-603 clinical device performance study was designed to
evaluate the safety and tolerability of its phase 1-ready NaviCap
device and the device’s localization and delivery function in
healthy volunteers. During the study, NaviCap devices filled with a
saline solution that included radioisotopes were ingested orally by
healthy volunteers. Scintigraphic imaging was used to indicate
device localization and payload delivery to the lower GI tract. No
drug was administered as part of this study.
Sequential scintigraphic images of NaviCap delivery in a BT-603
study subject can be viewed on the company’s website.
About the NaviCap™ Targeted Oral Delivery Platform and
BT-600 Biora'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 GItrac™ autolocation technology enables the
device to autonomously identify targeted locations in the GI tract
and release a therapeutic dose of up to 500µl.
Biora’s BT-600 program consists of a unique, liquid formulation
of tofacitinib delivered to the colon via the NaviCap device, for
the treatment of ulcerative colitis. 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. The company plans to
submit an Investigational New Drug (IND) application to begin a
Phase 1 study with its BT-600 program during the second half of
2023.
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
statements of historical facts included in this press release,
including statements concerning the progress and future
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identify forward-looking statements by terms such as “may,”
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statements involve known and unknown risks, uncertainties and other
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from the forward-looking statements expressed or implied in this
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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 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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