Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company that
is reimagining therapeutic delivery, today announced an update
regarding its Investigational New Drug (IND) application. The IND
application supports the next phase of development of BT-600, a
drug/device combination designed to use Biora’s NaviCap™ ingestible
drug delivery device with a proprietary liquid formulation of
tofacitinib, for the treatment of moderate to severe ulcerative
colitis.
“Near the end of the review period, the FDA requested additional
information on our IND for BT-600 and will need additional time to
complete review of our submission. We plan to address the agency’s
questions and submit our updated filing, potentially as early as
this week,” said Ariella Kelman, MD, Chief Medical Officer of Biora
Therapeutics. “We continue to have a constructive exchange with the
FDA, and while we cannot predict their response, we anticipate
remaining on track with our previously communicated execution
timeline,” continued Dr. Kelman.
The IND application for BT-600 includes extensive manufacturing,
preclinical, human device function, and toxicology data to support
a first-in-human clinical trial for BT-600. The phase 1 trial of
BT-600 is expected to be a randomized, double-blind,
placebo-controlled study to evaluate safety, pharmacokinetics and
pharmacodynamics, including effects on colon tissue, in healthy
volunteers receiving the NaviCap device filled with a novel liquid
formulation of tofacitinib at 5 mg and 10 mg doses. The NaviCap
device has been designed for targeted delivery directly to the
colon in this application.
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 submitted an Investigational New Drug (IND) application
to begin a phase 1 study for its BT-600 program in September
2023.
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, including plans, timing, and expectations regarding
submitting an updated IND filing, phase 1 trial readiness and
BT-600 program execution timelines, FDA acceptance, and trial
commencement, 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
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 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
Biora Therapeutics (NASDAQ:BIOR)
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