Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company that
is reimagining therapeutic delivery, presented a poster titled
“Results of human device function studies for the NaviCap™ Targeted
Oral Delivery Platform in healthy volunteers and patients with UC”
at the Digestive Disease Week® conference in Washington DC, on
Sunday, May 19, 2024.
“In four separate clinical studies, we evaluated the
functionality and safety of the NaviCap device in healthy
participants and in patients with active ulcerative colitis (UC),”
said Ariella Kelman, MD, Chief Medical Officer of Biora
Therapeutics. “The NaviCap device was well-tolerated in 81
administrations to 47 participants, releasing its payload in the
colon, regardless of variable GI transit time, the level of
inflammation, or the presence of blood in stool. The NaviCap
platform’s ability to function across variable GI conditions and
eating schedules illustrates its potential to deliver therapeutics
locally to the colon of patients with UC.”
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.
Four clinical device performance studies evaluated the
functionality and safety of the NaviCap device. Three studies
(PM-601, PM-602, and BT-603) used gamma scintigraphy to assess
delivery of radiolabeled payload into the colon in either healthy
participants or patients with active UC, and one study (PM-611)
assessed device function in healthy participants in both fasted and
fed states. All devices were safely ingested and exited the body
naturally, with no serious adverse events reported. No
investigational drug was administered during the studies. The
poster can be viewed by visiting
bioratherapeutics.com/publications.
About Digestive Disease WeekDigestive Disease
Week® (DDW) is the largest international gathering of physicians,
researchers and academics in the fields of gastroenterology,
hepatology, endoscopy and gastrointestinal surgery. Jointly
sponsored by the American Association for the Study of Liver
Diseases (AASLD), the American Gastroenterological Association
(AGA), the American Society for Gastrointestinal Endoscopy (ASGE)
and the Society for Surgery of the Alimentary Tract (SSAT), DDW is
an in-person and online meeting from May 18-21, 2024. The meeting
showcases more than 5,600 abstracts and hundreds of lectures on the
latest advances in GI research, medicine and technology. More
information can be found at www.ddw.org.
About the NaviCap™ Targeted Oral Delivery
PlatformBiora'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
anatomically targeted, direct delivery of therapeutics to the GI
tract 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 recently announced completion of its Phase 1 SAD/MAD
clinical trial to evaluate the safety and PK/PD of BT-600 in
healthy volunteers. BT-600 is a drug-device combination consisting
of the orally administered NaviCap™ device that delivers a unique,
liquid formulation of tofacitinib directly to the colon for the
potential treatment of moderate to severe ulcerative colitis.
Highlights from the SAD interim results can be found in the
corporate presentation on the company’s website. Final SAD/MAD
results are expected to be available in late Q2 2024.
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, preclinical
and clinical trial activities, and partnering and collaboration
efforts with third parties, 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,” “anticipate,” “forward,” “believe,”
“design,” “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 FDA filings and
initiate and execute 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 or partners, 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, 2023
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
Biora Therapeutics (NASDAQ:BIOR)
Historical Stock Chart
From May 2024 to Jun 2024
Biora Therapeutics (NASDAQ:BIOR)
Historical Stock Chart
From Jun 2023 to Jun 2024