Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company that
is reimagining therapeutic delivery, today announced completion of
the single-ascending dose (SAD) cohorts for its phase 1,
first-in-human clinical study of BT-600 in healthy adult
volunteers. BT-600 is a drug-device combination 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.
“Completion of the SAD cohorts of the clinical study is an
exciting step advancing clinical development for BT-600, and we are
pleased with the execution of the study and its progress so far,”
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, which we believe could lead to better outcomes for patients
suffering from ulcerative colitis.”
“We are on track to complete the multiple-ascending dose (MAD)
portion of the study, in which 24 participants will receive BT-600
with tofacitinib at 5 mg and 10 mg doses or placebo. We anticipate
sharing data from the SAD portion of the study during our corporate
update in March, and we plan to have final study data, which
includes all SAD and MAD cohorts, in the second quarter,” continued
Dr. Kelman.
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.
The phase 1 study is listed at clinicaltrials.gov
(NCT06275464).
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 Ulcerative Colitis Ulcerative colitis
(UC) is a chronic, inflammatory bowel disease that causes
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 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 our anticipated milestones, 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
“anticipate,” “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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