Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company that
is reimagining therapeutics, announced today the appointment of Dr.
Bruce Sands as board chair of its Clinical Advisory Board for
Inflammatory Bowel Disease (IBD), which also includes leading IBD
researchers Dr. Geert D’Haens, Dr. Brian Feagan, and Dr. Séverine
Vermeire. The clinical advisory board provides strategic guidance
on clinical development of Biora’s Targeted Therapeutics pipeline.
“Targeted drug delivery to the large intestine has the potential
to enable new therapeutic approaches, including combination
therapy, for IBD patients,” said Dr. Bruce Sands. “I’m pleased to
accept this role as chair of the IBD clinical advisory board and
help progress these urgently needed therapies into the clinic.”
“We thank Dr. Bruce Sands, who is one of the leading minds in
IBD clinical research, for his commitment to serve as chair of our
advisory board,” said Adi Mohanty, Chief Executive Officer of Biora
Therapeutics. “We are also fortunate to have several of the world’s
foremost experts in IBD research and clinical trials on our
advisory board, including Dr. Geert D’Haens, Dr. Brian Feagan, and
Dr. Séverine Vermeire. Their guidance will be invaluable as we
prepare to enter clinical trials with our targeted therapeutics
program in the coming months,” continued Mr. Mohanty.
Dr. Bruce Sands is the Dr. Burrill B. Crohn Professor of
Medicine at the Icahn School of Medicine at Mount Sinai, New York,
NY. Dr. Sands was awarded his BA and MD from Boston University and
trained in internal medicine at the Hospital of the University of
Pennsylvania. After completing GI fellowship at the Massachusetts
General Hospital, he joined the faculty of Harvard Medical School
and served as the Acting Chief of the Gastrointestinal Unit at MGH
before moving to Mount Sinai in 2010 as Chief of the Dr. Henry D.
Janowitz Division of Gastroenterology. Dr. Sands is widely
recognized for his clinical investigations of new therapeutics for
the inflammatory bowel diseases and has published over 250 original
manuscripts. He was the lead investigator of the landmark studies
ACCENT 2, UNIFI, and VARSITY, published in the New England Journal
of Medicine. Dr. Sands is also a paid consultant of Biora
Therapeutics.
Biographical information for all members of Biora’s Clinical
Advisory Board for Inflammatory Bowel Disease (IBD) can be found at
bioratherapeutics.com/leadership.
About Biora Therapeutics’ Targeted Therapeutics
Platform Biora Therapeutics’ targeted
therapeutics platform utilizes a novel approach that could improve
IBD patient outcomes by enabling delivery of therapeutics directly
to the site of disease. The objective is to increase 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. Recent data have
shown that targeted delivery of therapeutics has the potential to
improve patient outcomes in IBD.
Biora’s Drug Delivery System (DDS) is an ingestible capsule
designed for targeted delivery of therapeutics to improve treatment
of IBD. It is approximately the size of a fish oil capsule and
delivers a payload of up to 500µl liquid or solid formulation. Once
swallowed, the capsule is designed to autonomously identify
specific locations in the GI tract and release a therapeutic dose.
Previous studies in healthy volunteers demonstrated accurate
localization and delivery in a fasted state and also 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. The company also recently announced topline results from
its PM-602 device function study, which demonstrated successful
device performance in active ulcerative colitis (UC) patients.
Biora is a recipient of the Crohn’s and Colitis Foundation IBD
Ventures development grant to, in part, support development and
further clinical evaluation of the DDS platform, which aims to
improve quality of life for patients with inflammatory bowel
disease.
Biora is developing the PGN-600 program, which consists of a
liquid formulation of tofacitinib delivered to the colon via the
DDS capsule, for the treatment of ulcerative colitis. The company
has shown preclinically in canines that successful targeted
delivery using PGN-600 can lead to reduced drug levels in blood and
increased drug levels in tissue at least 25 times higher along the
length of the colon as compared to the equivalent standard oral
dose.
About Biora TherapeuticsBiora Therapeutics is
the biotech company that is reimagining therapeutics. 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 envisions a world where patients have access to needle-free
drug delivery and better therapeutic outcomes.
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 efforts, 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” 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 precision medicine, risks related to the supply and
manufacturing of and complexity of components in our devices, 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 future revenue
generating opportunities with current or future pharmaceutical
collaborators, our ability to raise sufficient capital to achieve
our business objectives, the ongoing COVID-19 pandemic, competition
from other companies, 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, 2021 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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