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CNTB - Connect Biopharma Holdings News Story

$22.1 0.1  0.5%

Last Trade - 28/07/21

Sector
Healthcare
Size
Mid Cap
Market Cap £884.3m
Enterprise Value £1.11bn
Revenue £n/a
Position in Universe 2686th / 7000

Connect Biopharma Completes Enrollment of CBP-201 Global Phase 2 Clinical Trial in Moderate-to-Severe Atopic Dermatitis

Thu 8th April, 2021 1:00pm
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SAN DIEGO and TAICANG, China, April 08, 2021 (GLOBE NEWSWIRE) -- 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 it has completed full enrollment of the phase 2 clinical trial evaluating
CBP-201 in adult patients with moderate-to-severe Atopic Dermatitis (AD).

The global, randomized, double-blind, placebo-controlled, dose-ranging
clinical trial to assess the efficacy, safety, and pharmacokinetics (PK)
profile of CBP-201, was designed to enroll 220 subjects and is being conducted
at 60 sites across the US, China, Australia, and New Zealand. CBP-201 or
placebo was administered to eligible adult subjects with moderate-to-severe AD
for 16 weeks with 8 weeks of follow up (NCT04444752).

“The completion of enrollment of the CBP-201 global phase 2 trial in
patients with moderate-to-severe AD is an important step for Connect and our
lead clinical program,” said Zheng Wei, PhD, Co-founder and CEO of Connect
Biopharma. “A significant unmet need still exists for patients and we
believe that CBP-201 has the potential to show a differentiated profile to
address it. We are optimistic that the results from this study, expected in
the second half of this year, will continue to support our hypothesis.”

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. It is estimated that 26.1 million people in the United
States have AD, of which 6.6 million have moderate-to-severe disease. It is
estimated that 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 is a novel IL-4Rα monoclonal antibody that has shown a favorable
safety and efficacy profile in a Phase 1b clinical trial in adult patients
with moderate-to-severe AD. CBP-201 was shown to be well tolerated with no new
safety signals compared to other approved IL-4Rα blockers, and no reported
injection site reactions or conjunctivitis. The proportion of patients given
CBP-201 150mg or 300 mg or placebo, weekly for 4 weeks, who achieved an
Investigator Global Assessment score of clear or almost clear skin (IGA 0,1)
was 50%, 42.9% and 12.5% respectively. Additionally, skin lesion improvements
were rapid, as evidenced as early as one week after dosing and were correlated
with a rapid reduction in pruritus intensity and frequency. This suggests the
potential for a differentiated efficacy profile, with fast onset of action for
CBP-201 compared with data from clinical trials of the current biologic
standard of care therapy.

About Connect Biopharma Holdings Limited

Connect 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), which is a validated target for the
treatment of several inflammatory diseases such as atopic dermatitis (AD) and
asthma. Our second lead product candidate is CBP-307, a modulator of a T cell
receptor known as sphingosine 1-phosphate receptor 1 (S1P1). Specifically, we
are developing CBP-307 for two types of inflammatory bowel disease (IBD),
ulcerative colitis (UC) and Crohn’s disease (CD).

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 timing of the results of the Company's phase
2 clinical trial evaluating CBP-201 in adult patients with moderate-to-severe
AD. 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) 867-1768
david.carey@finnpartners.com

Erich Sandoval (Media)
T: +1-(917)-497-2867
erich.sandoval@finnpartners.com

Corporate Contacts:
info@connectpharm.com

(https://www.globenewswire.com/NewsRoom/AttachmentNg/78b51790-903f-4b00-8502-27ce6a2a5b10)



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