Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company
reimagining therapeutic delivery, presented supplemental data from
the Phase 1 trial of BT-600 during the company’s virtual KOL event
on Wednesday, July 17, 2024. BT-600, an orally administered
drug-device combination, is 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.
“We are excited by the colon tissue drug exposure we are seeing
in this trial,” said Ariella Kelman, MD, Chief Medical Officer of
Biora Therapeutics. “We observed levels above the IC50 at 24 hours
and five half-lives after dosing, despite extensive pre-procedure
colon prep. We know higher tissue levels are associated with better
responses to tofacitinib in UC, and our model projects tissue
levels well above IC90 through at least 16 hours post dose. This is
especially notable since we studied daily doses of 5 mg and 10 mg
in this trial, which are 50–75% lower than approved doses for
conventional tofacitinib. We also observed lower systemic
concentrations, which may be associated with reduced toxicity
risks.”
Tissue biopsies were performed to assess drug concentration in
colonic tissues at 24 hours after dosing during the Phase 1 trial
in healthy participants. Mean tissue concentrations for the splenic
flexure, descending colon, and sigmoid colon were above the
established IC50 for the JAK-STAT pathway, and a strong correlation
was shown between tissue and corresponding plasma levels. The
plasma/tissue correlation was used to model tissue levels at
earlier time points, with the model projecting tissue levels above
the IC90 through at least 16 hours after BT-600 5 mg or 10 mg
doses.
“The results of this trial confirm that BT-600 can deliver drug
topically throughout the length of the colon and could achieve both
of our pharmacokinetic goals: higher tissue exposure and lower
systemic concentrations. This certainly gives us confidence as we
move into our planned clinical trial in UC patients,” continued Dr.
Kelman.
“There is an urgent need to break the therapeutic ceiling of
20–30% remission rates over placebo in UC,” said Adi Mohanty, Chief
Executive Officer of Biora Therapeutics. “We plan to break through
by changing the way gastrointestinal diseases are treated with our
NaviCap platform, which can reliably deliver to specific locations
within the GI tract. The clinical trial results for our current
program, BT-600, demonstrate its potential and also provide proof
of concept for the NaviCap platform’s ability to deliver other
molecules and drug classes in UC and beyond.”
Biora’s virtual KOL event on July 17 featured 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 discussed the unmet need and
current treatment landscape for patients with UC, as well as the
value of colonic drug delivery for improving efficacy. A replay of
the live event can be accessed on the company’s website.
SUMMARY OF KEY BT-600 PHASE 1 TRIAL
RESULTSResults from the Phase 1 clinical trial demonstrate
a pharmacokinetic (PK) profile consistent with drug delivery and
absorption in the colon for both single and multiple ascending dose
(SAD/MAD) cohorts:
- First evidence of systemic absorption of tofacitinib was at six
hours, consistent with colonic (vs. upper gastrointestinal)
delivery. Maximal levels in the trial occurred at eight to ten
hours vs. 30 minutes for conventional oral tofacitinib in other
trials.
- Maximal systemic drug exposure was three to four times lower
than that seen with conventional oral tofacitinib in other trials,
demonstrating the NaviCap platform’s ability to deliver locally to
the colon and limit systemic drug exposure.
The distribution of colon tissue exposure suggests that
pan-colonic delivery of tofacitinib was achieved:
- Sites in the distal colon were biopsied, following delivery of
tofacitinib in the proximal colon.
- Biopsy results provided evidence of drug exposure extending to
the distal colon, at common sites of disease.
- Modeling projects tissue levels at or above the estimated IC90
through at least 16 hours after dosing.
- Post-retrieval device analysis further confirmed that NaviCap
devices accurately delivered drug in the colon, with no early
release, and with >95% of devices detecting colon entry.
NaviCap devices were well tolerated by participants in both the
SAD and MAD cohorts:
- All AEs were mild and consistent with those expected in a
healthy population.
- No evidence of device or drug colon toxicity; colon tissue
histology was within normal limits.
- There were no notable changes or differences in safety
laboratory parameters between groups.
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, including those involving BT-600 and
our NaviCap platform and model projections, and partnering and
collaboration efforts with third parties, are forward-looking
statements. In some cases, you can identify forward-looking
statements by terms such as “envision,” “may,” “might,” “will,”
“objective,” “intend,” “should,” “could,” “can,” “would,” “expect,”
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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
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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
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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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