Connect Biopharma Provides Business and Clinical Development Program Update
30 Diciembre 2022 - 6:30AM
Connect Biopharma Holdings Limited (Nasdaq: CNTB) (Connect
Biopharma or the Company), a global clinical-stage
biopharmaceutical company developing T cell-driven therapies to
treat inflammatory diseases, today provided a business update for
its operations and clinical trial development programs.
“We continue to have great confidence in our global development
strategy, and particularly in the potential of our lead product
candidate, CBP-201, which is currently in development to treat
atopic dermatitis and asthma,” said Zheng Wei, PhD, Co-Founder and
CEO of Connect Biopharma. “Yet, in light of the current
macroeconomic climate and challenging funding environment, we feel
that it is necessary and financially prudent to commence our Global
Phase 3 program for CBP-201 in moderate-to-severe AD after we have
secured the partnership necessary to fully complete the program.
The CBP-201 Global Phase 3 program in AD was to commence before the
end of the year, and our ongoing pivotal AD trial in China is
unaffected and remains on track.”
“With this change in timing for our Global Phase 3 program in
AD, we expect our cash runway, without taking into account any
additional funding, to extend into at least 2025 - more than a year
longer than previously forecasted - which is meaningful,
particularly under current capital market conditions,” said Steven
Chan, CFO of Connect Biopharma. “We anticipate that this longer
runway will allow us to meet the milestones for our ongoing
clinical trials and advance our preclinical assets toward the
clinic, while we continue to evaluate partnership
opportunities.”
The Company is actively seeking potential global
and regional partners who would be able to provide additional
experience and infrastructure to support the next phase of clinical
development for CBP-201, including providing potential input into
the clinical trial designs that furthers Connect Biopharma’s goal
of delivering a differentiated therapeutic program with improved
efficacy and dosing convenience. Partnership efforts focus on
CBP-201’s potential not only in AD, but also in other disease
indications with significant unmet need including asthma, which is
in Phase 2, and for which the Company expects to report topline
results during the second half of 2023.
CBP-201 Pivotal AD trial in
China
In October 2022, Connect Biopharma announced
positive topline Stage 1 data on the primary analysis population of
255 patients and is currently conducting the 36-week Stage 2
period, which importantly, includes a potentially differentiated
once a month dose regimen. The Company expects to have pre-New Drug
Application (NDA) interactions with the Center for Drug Evaluation
(CDE) of China’s National Medical Products Administration in the
first quarter of 2023 to discuss the Company’s CBP-201 data package
for a potential NDA filing as early as 2024 and potential approval
in China as early as 2025.
CBP-307 Phase 2 trial in
moderate-to-severe Ulcerative Colitis (UC)
The Company also anticipates completing the
global Phase 2 maintenance phase for CBP-307 in the first half of
2023. The Company reported efficacy data in May 2022 for the
12-week induction phase of the trial showing CBP-307 0.2 mg once
daily administration led to a significantly higher number of
patients compared to placebo achieving clinical remission based on
adapted Mayo score. The Company is actively seeking to
out-license CBP-307 for future trials in UC and Crohn’s disease to
capitalize on its potential to be a competitive asset and a welcome
addition to the gastroenterologist’s treatment armamentarium.
CBP-174 in Pruritus associated with
AD
The Company previously reported results from its
Phase 1 single ascending dose study for CBP-174 in pruritus
associated with AD and is continuing to evaluate next steps for
clinical development.
Anticipated 2023 Milestones
- CBP-201 Pivotal China trial
in AD: On track to engage with the CDE in the first
quarter of 2023. Anticipate 36-week Stage 2 completion in the
second half of 2023
- CBP-201 in Asthma:
Anticipate completing enrollment for the global Phase 2 trial in
the first half of 2023 and reporting top-line results in the second
half of 2023
- CBP-307 in UC:
Anticipate completing Phase 2 maintenance phase and reporting the
results in the first half of 2023
About Connect Biopharma Holdings
Limited
Connect Biopharma is a U.S. and China-based
clinical-stage biopharmaceutical company dedicated to improving the
lives of patients with inflammatory diseases through the
development of therapies derived from T cell research. The Company
is building a rich pipeline of proprietary small molecules and
antibodies, using functional T cell assays, to screen and discover
potent product candidates against validated immune targets. The
Company’s lead product candidate, CBP-201, is an antibody designed
to target interleukin-4 receptor alpha in development for the
treatment of atopic dermatitis and asthma. The Company’s second
most advanced product candidate, CBP-307, is a modulator of S1P1 T
cell receptor and is in development for the treatment of ulcerative
colitis. The Company’s third product candidate, CBP-174, is a
peripherally acting antagonist of histamine receptor 3, in
development for the treatment of pruritus associated with atopic
dermatitis.
For more information, please visit:
https://www.connectbiopharm.com/
Forward-Looking Statements
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,” “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 expectations with respect to how long its current cash
position will support its operation needs and capital expenditure
requirements, the Company’s plans to advance the development of its
product candidates, the Company’s ability to out-license any of its
product candidates or to obtain partnership funding for any of its
development programs, the timing of achieving any development or
regulatory milestones, and the potential of such product
candidates, including to achieve any benefit or profile or any
product approval. The inclusion of forward-looking statements
should not be regarded as a representation by Connect Biopharma
that any of its plans will be achieved. Actual results may differ
materially from those set forth in this release due to the risks
and uncertainties inherent in the Company’s 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
Ina McGuinness
805.427.1372
imcguinness@connectpharm.com
MEDIA
Deanne Eagle
917.837.5866
deanne@mcguinnessIR.com
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