Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company that
is reimagining therapeutic delivery, today announced completion of
dosing for the multiple-ascending dose cohorts for its clinical
study of BT-600, a drug-device combination consisting of the orally
administered NaviCap™ device that delivers a proprietary liquid
formulation of tofacitinib to the colon. BT-600 is being developed
for the potential treatment of patients with ulcerative colitis
(UC). The MAD portion of the trial evaluated daily doses of BT-600
for seven days at 5 mg and 10 mg tofacitinib or placebo, in healthy
adult participants.
“Data from daily dosing in the MAD portion of the trial can
further our confidence in device performance and build upon what we
learned from the SAD cohorts, which demonstrated the NaviCap
platform’s unique ability to achieve localized delivery to the
colon, with a corresponding reduction in systemic drug exposure,”
said Ariella Kelman, MD, Chief Medical Officer of Biora
Therapeutics. “Research has shown that increased colon tissue
exposure, which is our goal with localized therapeutic delivery, is
correlated with better outcomes for patients suffering from UC. We
expect to receive data from the study, including all SAD and MAD
cohorts, this quarter.”
Biora previously shared positive interim results from the
single-ascending dose (SAD) portion of the clinical trial.
Highlights from the interim results can be found in the corporate
presentation on the company’s website.
About BT-600BT-600 is a drug/device combination
designed to use Biora’s 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.
Phase 1 Clinical Trial DesignThe objectives of
this phase 1 randomized, double-blind, placebo-controlled, single
and multiple ascending dose (SAD/MAD) clinical trial are to
evaluate the safety, pharmacokinetics and pharmacodynamics,
including effects on colon tissue, of BT-600 when administered
orally in healthy adult participants. The study, conducted in the
United States, consists of two parts. The first part is comprised
of 24 participants receiving a single ascending dose of BT-600 with
tofacitinib at 5 mg or 10 mg doses or placebo. The second part is
comprised of 24 participants receiving multiple ascending-doses of
BT-600 with tofacitinib at 5 mg or 10 mg doses or placebo daily for
7 days. The trial is listed at clinicaltrials.gov
(NCT06275464).
About the NaviCap™ Targeted Oral Delivery
Platform 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 direct delivery
of therapeutics has the potential to improve patient outcomes in
IBD.
The NaviCap platform uses an ingestible device designed for
direct 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. 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 UC also
demonstrated successful device performance in active UC patients.
About Ulcerative Colitis Ulcerative colitis
(UC) is a type of IBD that causes chronic inflammation and damage
to the colon. Common symptoms include abdominal pain, increased
bowel movements, stool urgency, and rectal bleeding. Despite the
availability of advanced treatments for UC, including biologics,
immunomodulators, and targeted synthetic small molecules, only
about 40% of patients achieve clinical remission in induction
trials. Surgical intervention is needed in approximately 20% of UC
patients, with up to 10% of patients requiring surgical removal of
the colon. About 1.5 million people are affected with UC in the
United States alone, and ~40,000 new cases are diagnosed each
year.
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 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,” “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 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
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