Connect Biopharma Holdings Limited (Nasdaq: CNTB) (“Connect
Biopharma” or the “Company”), a global clinical-stage
biopharmaceutical company dedicated to improving the lives of
patients with chronic inflammatory diseases through the development
of therapies derived from T cell-driven research, today announced
top-line results at 12 weeks from its Phase 2 trial for CBP-307
(CBP-307CN002), a once-daily, orally administered, selective
sphingosine 1-phosphate (S1P) receptor modulator in development for
the treatment of ulcerative colitis (UC).
Administration of CBP-307 0.2 mg demonstrated a
numerical reduction for the primary endpoint of least squares (LS)
mean change from baseline in adapted Mayo Score at Week 12 that did
not meet statistical significance. A significantly higher
proportion of patients who received CBP-307 0.2 mg dose achieved
Clinical Remission based on both the complete and adapted Mayo
Scores, which has been accepted by the FDA as the primary endpoint
in clinical trials that have supported prior approvals for
treatments of UC. Additionally, reductions in lymphocyte counts
amongst individuals receiving CBP-307 0.2 mg confirmed
pharmacodynamic activity of CBP-307 in patients with active UC.
“Ulcerative colitis is a serious chronic
condition with continued unmet need. The overall 12-week results
for CBP-307 demonstrate the therapeutic potential to induce a
significant treatment response consistent with clinical data of
other S1P modulators in patients with UC,” said David T. Rubin, MD,
Professor of Medicine and Chief of the Section of Gastroenterology,
Hepatology, and Nutrition at The University of Chicago
Medicine.
The primary endpoint of LS mean change from
baseline in adapted Mayo Score (stool frequency, rectal bleeding,
and endoscopy scores) at Week 12 for CBP-307 0.2 mg and placebo
were -2.65 and -2.01, respectively (p=0.103). Secondary endpoints
that were met for CBP-307 0.2 mg included a significantly higher
proportion of patients reaching Clinical Remission compared to
placebo as measured by both adapted (28.3% vs 9.6%,
difference=18.7; p=0.016) and complete Mayo Scores (18.9% vs 5.8%,
difference=13.1; p=0.044), respectively. For patients receiving
CBP-307 0.2 mg, significant improvements were also noted for change
in complete Mayo Score (adapted Mayo Score with physician’s global
assessment) from baseline to Week 12 (LS Mean Change from Baseline
for CBP-307 vs. placebo: -3.67 vs -2.74, p=0.05) and in Clinical
Response as measured by complete Mayo Score (52.8% vs 30.8%,
p=0.023). Analysis of exploratory pharmacodynamic endpoints showed
that patients receiving CBP-307 0.2 mg demonstrated a mean percent
lymphocyte count reduction from baseline of 51.2% with mean
absolute lymphocyte counts reduced to approximately 0.8 (109/L) at
week 12.
Across the CBP-307 0.2 mg and placebo groups,
the occurrence of drug-related treatment emergent adverse events
(TEAEs) was 66.0% and 38.5%, respectively. In addition, CBP-307 0.2
mg and placebo groups were similar in the occurrence of Grade 3 or
higher TEAEs (7.5% vs 7.7%, respectively) and Serious TEAEs (3.8%
vs 5.8%, respectively). There were no cases of progressive
multifocal leukoencephalopathy and no deaths. The overall safety
results in this study showed CBP-307 to be generally well tolerated
in patients with moderate-to-severe UC. Given the safety findings
along with the efficacy results of this study, the Company believes
that CBP-307 warrants further clinical development in UC.
“These top-line, induction phase data
demonstrate the potential for CBP-307 to provide benefit to
patients living with moderate-to-severe UC,” said Zheng Wei, Ph.D.,
Co-Founder and CEO of Connect Biopharma. "Together, with recent
positive results from our Phase 2 study of CBP-201 in atopic
dermatitis, they support our approach to T cell-driven research in
immunological pathways. To focus our resources to advance CBP-201,
our lead product candidate, in a global Phase 3 clinical program
and the ongoing pivotal China trial for atopic dermatitis, we plan
to explore strategic partnerships to progress CBP-307 into future
trials.”
An accompanying deck of today’s CBP-307 data is
available in the Events and Presentations section of Connect
Biopharma’s Investor Relations site at
https://investors.connectbiopharm.com/presentations-events/events.
About CBP-307CN002 Trial
CBP-307CN002 is an active Phase 2 study
evaluating the efficacy and safety of CBP-307 as an induction and
maintenance therapy in adult patients with moderate-to-severe UC.
The randomized, double-blind, placebo-controlled, multi-center
study enrolled a total of 145 patients in two active dose arms
(CBP-307 0.1 mg [n=39]; CBP-307 0.2 mg [n=53]) and a placebo arm
(n=53) from over 60 sites in 4 countries.
About Ulcerative Colitis
Ulcerative Colitis (UC) is an idiopathic
inflammatory condition of the mucosal and submucosal colon that has
a globally increasing prevalence thought to be driven by societal
changes. There are approximately 600,000 to 900,000 people in the
United States living with ulcerative colitis. When insufficiently
controlled, UC leads to progressive organ damage that presents as
functional impairment and anatomical changes such as dysplasia,
which may ultimately progress to cancer. Despite the availability
of new treatments that have advanced the standard of care, a
“therapeutic ceiling” means that treatment options remain limited
and clinical remission is still not achieved in 70–80%
patients.
About CBP-307
Discovered internally using Connect Biopharma's
proprietary Immune Modulation Technology, CBP-307 is an orally
administered small molecule designed to modulate sphingosine
1-phosphate receptor 1 (S1P1), which is a validated target for the
treatment of several inflammatory diseases, including UC. CBP-307
was observed to be generally well tolerated and showed evidence of
clinical activity in the induction period of a Phase 2 clinical
trial in adults with moderate-to-severe UC, suggesting a potential
for a differentiated risk–benefit profile compared with data from
clinical trials of current orally administered therapies. CBP-307
is also the subject of an ongoing maintenance phase and safety
follow-up in the Phase 2 UC trial and two completed and two ongoing
Phase 1 trials in healthy volunteers.
About Connect Biopharma Holdings
Limited
Connect Biopharma is a global, clinical-stage
biopharmaceutical company dedicated to improving the lives of
patients with inflammatory diseases through the development of
therapies derived from T cell-driven research. It is building a
rich pipeline of internally-designed, wholly-owned, small molecules
and antibodies using functional cellular assays with T cells to
screen and discover potent product candidates against validated
immune targets. Its lead product candidate, CBP-201, is an antibody
designed to target interleukin-4 receptor alpha (IL-4Rα) in
development for the treatment of atopic dermatitis (AD) and asthma.
The Company’s second most advanced product candidate, CBP-307, is a
modulator of a T-cell receptor known as S1P1 in development for the
treatment of UC. Clinical development has begun for its third
product candidate, CBP-174, a peripherally acting antagonist of
histamine receptor 3, for the treatment of pruritus associated with
AD.
With operations in the United States and China,
Connect Biopharma is building a rich global pipeline of molecules
and antibodies targeting several aspects of T cell biology. For
additional information, please visit www.connectbiopharm.com.
FORWARD-LOOKING STATEMENTS
(UPDATED)
Connect Biopharma cautions that statements
included in this press release that are not a description of
historical facts are forward-looking statements. Words such as
"may," "could," "will," "would," "should," "expect," "plan,"
"anticipate," "believe," "estimate," "intend," "predict," "seek,"
"contemplate," “look forward,” "potential," "continue" or "project"
or the negative of these terms or other comparable terminology are
intended to identify forward-looking statements. These statements
include the Company’s plans to advance the development of its
product candidates, the potential of such product candidates,
including to achieve any benefit or profile, and trends within the
ulcerative colitis population, and partnerships for the future
development of CBP-307. The inclusion of forward-looking statements
shall not be regarded as a representation by Connect Biopharma that
any of its plans will be achieved. Actual results may differ from
those set forth in this release due to the risks and uncertainties
inherent in the Connect Biopharma business and other risks
described in the Company's filings with the Securities and Exchange
Commission (“SEC”), including the Company’s Annual Report on Form
20-F filed with the SEC on March 31, 2022, and its other reports.
Investors are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date hereof,
and Connect Biopharma undertakes no obligation to revise or update
this news release to reflect events or circumstances after the date
hereof. Further information regarding these and other risks is
included in Connect Biopharma's filings with the SEC which are
available from the SEC’s website (www.sec.gov) and on Connect
Biopharma’s website (www.connectbiopharm.com) under the heading
"Investors." All forward-looking statements are qualified in their
entirety by this cautionary statement. This caution is made under
the safe harbor provisions of Section 21E of the Private Securities
Litigation Reform Act of 1995.
INVESTOR CONTACT:David
Carey Lazar FINN Partners T: +1-(212)
867-1768david.carey@finnpartners.com
MEDIA CONTACT:Erich
SandovalLazar FINN Partners +1 (646) 871-8482 or +1 (917)
497-2867erich.sandoval@finnpartners.com
CORPORATE
CONTACT:info@connectpharm.com
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