Connect Biopharma Announces First Subject Dosed in Phase 2 Trial Evaluating CBP-201 in Adult Patients with Chronic Rhinosinusitis with Nasal Polyps
September 08 2021 - 8:00AM
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
that the first subject has been dosed in a Phase 2 trial evaluating
CBP-201 in adult patients with chronic rhinosinusitis with nasal
polyps (“CRSwNP”).
This multi-center, randomized, double-blind,
placebo-controlled trial was designed to evaluate the effect of
CBP-201 administered as a subcutaneous injection (“SC”) on a
background of mometasone furoate nasal spray (“MFNS)” in reducing
endoscopic nasal polyp score (“NPS”) and nasal
congestion/obstruction score (“NCS”) severity in eligible patients
with CRSwNP whose disease remains inadequately controlled despite
daily treatment with intranasal corticosteroid (“INCS”) therapy in
comparison to placebo. The trial is divided into a treatment period
of 24 weeks and a follow-up period of 8 weeks and is expected to
enroll approximately 140 patients with CRSwNP across approximately
60 clinical sites in the United States, China, European Union and
Eurasian Economic Union (NCT04783389).
“CRSwNP is a chronic inflammatory condition that
can cause long-term symptoms that negatively affect patients’
health-related quality of life,” says Dr. Rodney J. Schlosser,
M.D., Director of Rhinology and Sinus Surgery at the Medical
University of South Carolina, Investigator in the Phase 2 study.
“Current treatment options for CRSwNP are limited, some patients do
not respond well and there is an unmet need for therapies that can
prove to be effective and safe in controlling symptoms and
minimizing reoccurrences.”
“The initiation of this global clinical trial in
CRSwNP expands our ongoing research programs exploring the
potential of CBP-201 in patients with atopic dermatitis and asthma,
and reinforces our commitment to developing treatment solutions for
patients suffering with chronic type 2 inflammatory diseases where
IL-4 and IL-13 are known to play critical roles,” said Zheng Wei,
PhD, Co-founder and CEO of Connect Biopharma.
About Chronic Rhinosinusitis with Nasal
Polyps Chronic rhinosinusitis (CRS), which is
characterized by chronic inflammation of the nasal mucosa and
paranasal sinuses, is a common condition with an estimated
prevalence of 5-12% of the general population. Approximately 25-30%
of individuals with CRS develop nasal polyps, which are growths
that occur in the nasal passages and sinuses and are frequently
associated with asthma, allergic rhinitis and chronic
rhinosinusitis. As nasal polyps increase in size and/or number,
they can interfere with normal breathing and may lead to a loss of
sense of smell. In some cases, nasal polyps may need to be removed
surgically. Patients with CRSwNP may experience significant
morbidity and can have decreased quality of life. Despite the
availability of an injectable biologic for nasal polyps due to
chronic rhinosinusitis, many patients continue to have unmet
medical need.
About CBP-201CBP-201,
discovered internally using Connect Biopharma's proprietary Immune
Modulation Technology Platform, is an antibody designed to target
interleukin-4 receptor alpha (IL-4Rα), which is a validated target
for the treatment of several inflammatory diseases including atopic
dermatitis (AD). CBP-201 has shown a favorable safety and efficacy
profile in a Phase 1b clinical trial in adult patients with
moderate-to-severe atopic dermatitis, suggesting a potential for a
differentiated efficacy profile compared with data from clinical
trials of the current biologic standard of care therapy. CBP-201 is
currently being evaluated in a global Phase 2b trial in adult
patients with moderate-to-severe atopic dermatitis (NCT04444752),
in a China specific pivotal trial in adults with moderate-to-severe
atopic dermatitis (NCT05017480), in a Phase 2b trial in adult
patients with moderate-to-severe persistent asthma (NCT04773678)
and in a Phase 2b trial in adult patients with chronic
rhinosinusitis with nasal polyps (CRSwNP) (NCT04783389).
About Connect Biopharma Holdings
LimitedConnect Biopharma Holdings Limited is a global
clinical-stage biopharmaceutical company dedicated to improving the
lives of patients living with chronic inflammatory diseases through
the development of therapies derived from our T cell-driven
research.
Our lead product candidate, CBP-201, is an
antibody designed to target interleukin-4 receptor alpha (IL-4Rα)
and is currently being evaluated in clinical trials for the
treatment of atopic dermatitis (AD), Asthma and chronic
rhinosinusitis with nasal polyps (CRSwNP). Our second lead product
candidate is CBP-307, a modulator of a T cell receptor known as
sphingosine 1-phosphate receptor 1 (S1P1) that is in clinical
trials for ulcerative colitis (UC) and Crohn’s disease (CD).
Furthermore, we have started the clinical development of CBP-174, a
peripherally restricted antagonist of histamine receptor 3, for the
treatment of pruritus associated with AD.
With headquarters in China, additional
operations in the United States and Australia, and clinical
development activities in those geographies as well as Europe,
Connect Biopharma is building a rich global pipeline of internally
designed, wholly owned small molecules and antibodies targeting
several aspects of T cell biology. For additional information about
Connect Biopharma, please visit our website at
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 statements regarding the potential of CBP-201 to achieve
a differentiated profile to address the unmet needs of patients
with CRSwNP and the size, the duration, and/or the results of the
Company's Phase 2 clinical trial evaluating CBP-201 in adult
patients with CRSwNP. 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
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"). 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.
IR/PR Contacts: Lazar FINN Partners David
Carey (IR) T: +1-(212)
867-1768david.carey@finnpartners.comErich Sandoval
(Media)T:
+1-(917)-497-2867erich.sandoval@finnpartners.com
Corporate
Contacts:info@connectpharm.com
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