Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company
reimagining therapeutic delivery, today shared positive topline
results from its clinical trial of BT-600, an orally administered
drug-device combination in development for the potential 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. Results from this
Phase 1 clinical trial involving 48 healthy volunteers met all
trial objectives, with demonstrated drug absorption in colonic
tissue that extended to the distal colon, suggesting pan-colonic
delivery. Daily dosing with BT-600 was well tolerated by all
participants.
“Successful completion of our Phase 1 clinical trial is an
important milestone for Biora,” said Ariella Kelman, MD, Chief
Medical Officer of Biora Therapeutics. “All study objectives were
met, and we confirmed that the NaviCap platform can deliver
tofacitinib topically to the colon, with lower peak systemic
exposure than with conventional oral delivery. These results
support our plan to advance BT-600 into our Phase 1b clinical
trial in patients with UC.”
“We are extremely encouraged by the results from this trial,
which demonstrate the NaviCap platform’s ability to deliver drug to
the location of disease, where it’s needed,” said Adi Mohanty,
Chief Executive Officer of Biora Therapeutics. “Our anatomically
targeted approach has the potential to improve the efficacy of JAK
inhibitors and other drug classes. We envision a portfolio of
NaviCap-delivered therapeutics unlocking new treatment potential
for patients with GI diseases.”
“I would like to thank the study participants, clinicians, and
our Biora team for conducting such a well-executed trial,”
continued Mr. Mohanty. “Our team continues to execute at a high
level as we meet our NaviCap platform milestones, while the BioJet™
platform is also progressing well and is on track to meet our
previously stated goals.”
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, for evidence of tissue drug
exposure
- Biopsy results provided evidence of drug exposure extending to
the distal colon, at common sites of disease.
- Post-retrieval device analysis further confirmed that NaviCap
devices accurately delivered drug in the colon, with 100% of
devices (SAD) and 98% of devices (MAD) detecting colon entry.
NaviCap devices were well tolerated by participants in both
the SAD and MAD cohorts.
Virtual Event DetailsThe company will host a
KOL event with members of management and its Clinical Advisory
Board to provide additional details regarding the Phase 1 trial and
plans for the next phase of clinical development.
Date: |
|
Wednesday,
July 17, 2024 |
Time: |
|
2:00 PM Eastern / 11:00 AM Pacific time |
Live Webcast: |
|
https://lifescievents.com/event/biora/ |
|
Attendees may register in advance using the webcast link above.
A replay will be available online following the event.
Phase 1 Clinical Trial DesignThe objectives of
this Phase 1 randomized, double-blind, placebo-controlled, single
and multiple ascending dose (SAD/MAD) clinical trial were to
evaluate the safety and pharmacokinetics of BT-600 when
administered orally in healthy adult participants. The trial, which
was conducted in the United States, consisted of two parts: The
first part was 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 was 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). The “other trials” referred to in
the summary of the Phase 1 clinical trial results above were
conducted at different times, with differences in trial design and
patient populations. As a result, cross-trial comparisons cannot be
made and no head-to-head clinical trials have been conducted.
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 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,” “anticipate,”
“forward,” “believe,” “design,” “estimate,” “predict,” “potential,”
“plan,” “goal(s)” “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 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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