Connect Biopharma Announces First Patient Dosed in China Pivotal Trial Evaluating CBP-201 in Adults with Moderate-to-Severe Atopic Dermatitis
September 02 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 patient has been dosed in a China specific pivotal
trial evaluating CBP-201 in adults with moderate-to-severe atopic
dermatitis.
This multicenter, randomized, double-blind,
parallel group, placebo-controlled trial was designed to assess the
efficacy and safety of up to two doses of CBP-201 administered
subcutaneously (SC) to eligible patients with moderate to severe
atopic dermatitis. The trial is expected to enroll approximately
255 patients across 55 clinical sites in China and is divided into
an initial treatment period of 16 weeks, a further maintenance
period of 36 weeks and a follow-up period of 8 weeks
(NCT05017480).
“Atopic dermatitis is a chronic inflammatory
skin disease that significantly impacts patients’ quality of life,
and its prevalence in China is increasing, leading to a growing
burden for patients,” said Dr. Jianzhong Zhang, MD, Principal
Investigator and Director of the Dermatology Disease Department at
Peking University People’s Hospital. “Despite the recent approval
of a new biologic treatment in China, many patients do not achieve
a return to clear and normal skin. It is hoped that CBP-201, which
is capable of blocking both IL-4 and IL-13 that drive the
inflammation associated with atopic dermatitis may bring additional
benefit to patients, particularly in measures of efficacy and
possibly in lowering the burden of treatment through a need for
fewer injections.”
“The commencement of this China specific
clinical trial of CBP-201 in moderate to severe atopic dermatitis
is a significant step for Connect as we look to advance the
development pathway for CBP-201,” said Dr. Pauline Li, MD, Head of
Clinical Development, Asia for Connect Biopharma. “While we are
advancing CBP-201 across multiple indications in global trials,
this trial, if successful, could accelerate the availability of
CBP-201 to patients in China.”
About Atopic Dermatitis
Atopic dermatitis (AD), which has an estimated
lifetime prevalence of up to 20% and is increasing globally, is the
most commonly diagnosed chronic inflammatory skin disorder. It is
characterized by skin barrier disruption and immune dysregulation.
Estimates of prevalence of AD in China show this increasing over
time and recent longitudinal studies have reported a dermatologist
diagnosed prevalence of 7.8% in Chinese outpatients visiting
tertiary hospitals. In the United States, it is estimated that 26.1
million people have AD, of which 6.6 million have
moderate-to-severe disease. Further, over 58% of adults with
moderate-to-severe AD have disease which physicians consider to be
inadequately controlled by approved therapeutic modalities,
including topical anti-inflammatory agents and systemic agents.
About CBP-201
CBP-201, discovered 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
several Phase 2b clinical trials: in adult patients with
moderate-to-severe atopic dermatitis (NCT04444752), in adult
patients with moderate-to-severe persistent asthma (NCT04773678),
and in adult patients for the treatment of 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 development
for the treatment of ulcerative colitis (UC) and Crohn’s disease
(CD). Furthermore, we are developing CBP-174, a peripherally
restricted antagonist of histamine receptor 3, for the treatment of
pruritus associated with skin inflammation.
With current 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 AD and the size, the duration, and the results of the
Company's China only pivotal trial and phase 2 clinical trials of
CBP-201. 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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