Biora Therapeutics Announces FDA Clearance of IND Application for Drug/Device Combination BT-600 Targeting Treatment of Ulcerative Colitis
November 30 2023 - 3:48PM
Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company that
is reimagining therapeutic delivery, today announced that the U.S.
Food and Drug Administration (FDA) has cleared the company’s
Investigational New Drug (IND) application for BT-600, a
drug/device combination for the treatment of moderate to severe
ulcerative colitis.
“The FDA has agreed with our plans to proceed
with clinical development of BT-600 and has activated our IND
application. We appreciate the agency’s collaborative relationship
as they have worked with us to achieve what is, to our knowledge,
the first active IND for an ingestible drug and device
combination,” said Ariella Kelman, MD, Chief Medical Officer of
Biora Therapeutics. “We believe our therapeutic approach could lead
to better outcomes for patients suffering from ulcerative colitis.
We look forward to completing the activities required by FDA and
the trial site prior to enrolling the first subject in our phase 1
clinical trial in the United States in the coming weeks.”
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 treatment of
moderate to severe ulcerative colitis. The NaviCap device has been
designed for targeted delivery directly to the colon in this
application. The phase 1 trial of BT-600 is planned as a
randomized, double-blind, placebo-controlled, single and multiple
ascending dose study to evaluate safety, pharmacokinetics and
pharmacodynamics, including effects on colon tissue, in healthy
volunteers receiving BT-600 with tofacitinib at 5 mg and 10 mg
doses.
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.
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
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including statements concerning the progress and future
expectations and goals of our research and development and clinical
efforts including phase 1 trial readiness, phase 1 trial execution
timeline, phase 1 trial commencement, and working through the final
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ContactChuck PadalaManaging Director, LifeSci
AdvisorsIR@bioratherapeutics.com(646) 627-8390
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