Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company that
is reimagining therapeutic delivery, today announced initiation of
its phase 1, first-in-human clinical study of BT-600 in healthy
adult volunteers. BT-600 is a drug-device combination program
consisting of the orally administered NaviCap™ device which
delivers a unique, liquid formulation of tofacitinib to the colon
for the potential treatment of moderate to severe ulcerative
colitis.
“Initiation of this trial represents a critical step toward
establishing evidence for our novel therapeutic approach of
targeted, topical delivery of tofacitinib directly to the colon,
which we believe could lead to better outcomes for patients
suffering from ulcerative colitis,” said Ariella Kelman, MD, Chief
Medical Officer of Biora Therapeutics. “Direct delivery to the
colon with BT-600 has potential for improved efficacy driven by
increased colonic tissue exposure, while reducing
systemic-exposure-associated adverse events in patients with
UC.”
Dr. Kelman continued, “By evaluating both serum and tissue in
this phase 1 trial, we expect to receive important insight into the
pharmacokinetic and pharmacodynamic effects of BT-600, in addition
to safety data. We anticipate increased colonic tissue drug levels
and reduced systemic levels compared with conventional oral
tofacitinib. We look forward to sharing preliminary data from the
SAD portion of the study in two to three months, followed by final
SAD/MAD data in ensuing months.”
Phase 1 Study DesignThe objectives of this
phase 1 randomized, double-blind, placebo-controlled, single and
multiple ascending dose (SAD/MAD) clinical study are to evaluate
the safety, pharmacokinetics and pharmacodynamics, including
effects on colon tissue, of BT-600 when administered orally in
healthy adult volunteers. The study, which is being conducted in
the United States, consists of two parts. The first is a
single-dose ascending cohort comprised of 24 participants receiving
BT-600 with tofacitinib at 5 mg and 10 mg doses or placebo. The
second is a multiple-dose ascending cohort comprised of 24
participants receiving BT-600 with tofacitinib at 5 mg and 10 mg
doses or placebo.
About BT-600 BT-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.
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 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. 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 and research collaboration plans and expectations 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,
clearance, or acceptance of our clinical trials or 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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