Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company
reimagining therapeutic delivery, today announced further details
on its virtual event to be held on Wednesday, July 17, 2024. The
event will feature Bruce Sands, MD, MS (Icahn School of Medicine at
Mount Sinai) and Brian Feagan, MD, FRCPC (Schulich School of
Medicine & Dentistry at the University of Western Ontario), who
will discuss the unmet need and current treatment landscape for
patients with ulcerative colitis (UC), as well as the value of
colonic drug delivery for improving efficacy.
Biora leadership will highlight key results from the Phase 1
clinical trial of BT-600, an orally administered drug-device
combination in development for the treatment of patients with
ulcerative colitis (UC). BT-600 leverages Biora’s ingestible
NaviCap™ device to deliver a proprietary liquid formulation of
tofacitinib directly to the colon.
“I look forward to sharing details of our Phase 1 results, which
show the NaviCap platform reliably and precisely delivers drug
throughout the colon, including the sites most commonly affected in
patients with UC,” said Ariella Kelman, MD, Chief Medical Officer
of Biora Therapeutics. “Delivery of therapeutics directly to
affected tissues in the colon could improve patient outcomes in UC.
This clinical trial provides proof of concept for our anatomically
targeted approach to therapeutic delivery and gives us confidence
to study BT-600 next in patients with UC.”
A live question and answer session will follow the formal
presentations.
Virtual Event Details |
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Date: |
Wednesday, July 17, 2024 |
Time: |
2:00 PM Eastern / 11:00 AM Pacific time |
Registration: |
https://lifescievents.com/event/biora/ |
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A replay will be available online following the event.
About Bruce Sands, MD, MS Bruce Sands, MD, MS
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.
About Brian Feagan, MD, FRCPCBrian Feagan, MD,
FRCPC is a Professor of Medicine at the Schulich School of Medicine
& Dentistry at the University of Western Ontario, a
gastroenterologist at London Health Sciences Centre in Ontario,
Canada, and the Senior Scientific Director of Alimentiv, Inc. Dr.
Feagan completed his MD at the University of Western Ontario, and
his postdoctoral training included a residency in internal medicine
and a clinical fellowship in gastroenterology in the Department of
Medicine at UWO, and postgraduate training in the Department of
Epidemiology and Biostatistics at McMaster University, Ontario. His
research is focused on the development, validation and optimization
of outcome measures to assess the efficacy of novel therapeutics in
Crohn’s disease (CD) and ulcerative colitis (UC), with a specific
focus on the design and execution of large-scale randomized
controlled trials. Dr. Feagan has been the principal investigator
in over 140 multi-center randomized controlled trials in CD and
UC.
About BT-600BT-600 is a drug/device combination
of 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
anatomically targeted therapeutic delivery directly to the colon in
this application.
About the NaviCap™ Targeted Oral Delivery
PlatformBiora'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 activity 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
activity 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
ulcerative colitis. 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 of the NaviCap device in healthy volunteers and
patients with ulcerative colitis demonstrated successful delivery
to the colon regardless of variable GI conditions, in both fasted
and fed states.
About Ulcerative Colitis Ulcerative colitis
(UC) is a type of IBD that causes chronic 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, 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, 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 X.
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, preclinical
and clinical trial activities, and partnering and collaboration
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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 FDA filings and
initiate and execute 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 or partners, our ability to raise
sufficient capital to achieve our business objectives, our ability
to maintain our listing on the Nasdaq Global Market, 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, 2023
filed with the Securities and Exchange Commission (SEC) and other
subsequent documents, including Quarterly Reports on Form 10-Q,
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 ContactLiz RobinsonCG
Lifelrobinson@cglife.com
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