Biora Therapeutics Submits Updated IND Application for BT-600
31 10월 2023 - 5:05AM
Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company that
is reimagining therapeutic delivery, today announced that it
submitted an updated Investigational New Drug (IND) application for
BT-600 to the U.S. Food and Drug Administration (FDA) as planned.
The update includes additional clarifying information and provides
additional time for regulatory review of the company’s IND filing.
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, 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. The phase 1 trial of BT-600 is planned as 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-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 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.
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 phase 1 trial readiness and execution timeline,
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,”
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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
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