Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company that
is reimagining therapeutic delivery, today shared additional
positive interim results from the single-ascending dose (SAD)
clinical trial of BT-600, which is a drug-device combination
consisting of the orally administered NaviCap™ device that delivers
a proprietary liquid formulation of tofacitinib to the colon.
BT-600 is being developed for the potential treatment of patients
with ulcerative colitis (UC). The SAD portion of the phase 1
randomized, double-blind, placebo-controlled clinical trial tested
the tolerability and pharmacokinetics of BT-600 at 5 mg and 10 mg
doses of tofacitinib, compared to placebo, in healthy adult
participants.
“We are extremely pleased with the interim trial results, some
of which we shared during our recent quarterly call, that
demonstrate the NaviCap platform’s unique ability to achieve
localized delivery to the colon, with a corresponding reduction in
systemic drug exposure,” said Ariella Kelman, MD, Chief Medical
Officer of Biora Therapeutics. “Direct delivery of JAK inhibitors
to the colon has potential for improved efficacy driven by
increased colonic tissue exposure, while reducing toxicity risks
related to systemic exposure. We believe this could lead to better
outcomes for patients suffering from UC.”
According to the interim clinical data, all pharmacokinetic
endpoints were met in all study participants. BT-600 was well
tolerated with no serious adverse events. All devices performed as
intended, with all participants receiving BT-600 showing systemic
drug absorption. Tofacitinib was first detected in plasma at
approximately six hours following administration, which is
consistent with colonic delivery as opposed to absorption in the
upper GI tract. The mean time to reach maximum concentration (Tmax)
was 8–10 hours following administration of BT-600, versus 0.5-1.0
hours for conventional oral tofacitinib. Tofacitinib was present in
fecal samples of all subjects, further confirming delivery of the
drug in the colon.
Colonic delivery of BT-600 was associated with 3–4x lower
systemic absorption of tofacitinib, with a maximum plasma
concentration (Cmax) of 26 ng/mL for BT-600 at the 10 mg dose of
tofacitinib, versus 88 ng/mL for conventionally administered oral
tofacitinib at a 10 mg dose.
“Many IBD drugs could benefit from localized delivery—research
shows that for JAK inhibitors, integrin inhibitors and TNF
inhibitors, higher colon tissue concentrations correlate with
better outcomes,” said Adi Mohanty, Chief Executive Officer of
Biora Therapeutics. “Our NaviCap platform represents a new
therapeutic approach to UC and beyond. We continue to demonstrate
that our localized delivery technology can enable higher colon
tissue concentrations, without subjecting patients to high systemic
drug levels, and results from the SAD portion of our clinical trial
further confirm the platform’s capability.”
Highlights from the interim results can be found in the
corporate presentation on Biora’s website.
The multiple-ascending dose (MAD) portion of the trial,
currently underway, will evaluate daily doses of BT-600 for 7 days
at 5 mg and 10 mg tofacitinib or placebo. Final results are
expected to be available in late Q2 2024.
Phase 1 Clinical Trial DesignThe objectives of
this phase 1 randomized, double-blind, placebo-controlled, single
and multiple ascending dose (SAD/MAD) clinical trial are to
evaluate the safety, pharmacokinetics and pharmacodynamics,
including effects on colon tissue, of BT-600 when administered
orally in healthy adult participants. The study, which is being
conducted in the United States, consists of two parts. The first
part is comprised of 24 participants receiving a single ascending
dose of BT-600 with tofacitinib at 5 mg or 10 mg doses or placebo.
The second part is comprised of 24 participants receiving multiple
ascending-doses of BT-600 with tofacitinib at 5 mg or 10 mg doses
or placebo daily for 7 days. The trial is listed at
clinicaltrials.gov (NCT06275464).
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 UC also
demonstrated successful device performance in active UC
patients.
About Ulcerative Colitis Ulcerative colitis
(UC) is a chronic 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 clinical-stage 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 preclinical-stage 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 the progress and future
expectations and goals of our research and development,
preclinical, and clinical trial efforts including our BT-600
clinical trial execution and data timelines, 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,” “forward,”
“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 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, 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 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
A photo accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/9067f7a9-c86c-419f-9741-1e7c5cca0a40
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