Connect Biopharma Presents Data and Analyses from the Global Phase 2b Trial of CBP-201 at the Maui Derm Conference
January 24 2022 - 7:00AM
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 data from the global Phase 2b clinical trial of CBP-201
administered subcutaneously (SC) to adult patients with
moderate-to-severe atopic dermatitis (AD) (WW001) (NCT04444752),
will be presented in two abstracts and posters at the Maui Derm
Conference that begins today, January 24th, and ends January 28th,
in Maui, Hawaii.
The abstracts and posters will expand on the topline results
reported by the Company on January 5, 2022, which demonstrated that
CBP-201 met the primary and key secondary efficacy endpoints of the
trial, with favorable safety data reporting low incidences of
injection site reactions, conjunctivitis and herpes infections.
The abstracts and posters will also provide detail of the
analyses performed by the Company of patients within the trial with
higher baseline disease severity that more closely approaches the
disease severity in Phase 3 trials of the approved IL-4R agent.
These analyses consistently demonstrate increased efficacy as
baseline disease severity increases, indicating that CBP-201 has
the potential for a highly competitive efficacy and safety profile
that includes a differentiated Q4W dosing schedule.
Poster Presentation Details
Title: Efficacy and Safety of CBP-201 in Adults with
Moderate-to-Severe Atopic Dermatitis (AD): A Phase 2b, Randomized,
Double-blind, Placebo-controlled Trial (CBP-201-WW001)
Presenter: Bruce Strober
Title: The Effect of Baseline Disease Characteristics on
Efficacy Outcomes: Results from a Phase 2b, Randomized,
Double-blind, Placebo-controlled Trial (CBP-201-WW001).
Presenter: Jonathan I. Silverberg
Both posters will be available on the Presentations and
Publications section of the Connect Biopharma website Monday,
January 24, 2022:
https://www.connectbiopharm.com/our-science/presentations-and-publications/.About
Atopic DermatitisAtopic 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 an
increase 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 that physicians consider to be
inadequately controlled by approved therapeutic modalities,
including topical anti-inflammatory agents and systemic agents.
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 was well tolerated and showed evidence of clinical activity
in a Phase 2b clinical trial (NCT04444752) 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
also being evaluated 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 — an antibody designed to
target interleukin-4 receptor alpha (IL-4Rα) — has been in clinical
trials for the treatment of AD, asthma, and CRSwNP. Our second lead
product candidate, CBP-307 — a modulator of a T cell receptor known
as sphingosine 1-phosphate receptor 1 (S1P1) — has been in clinical
trials for the treatment of ulcerative colitis (UC) and Crohn’s
disease (CD). Furthermore, we have started the clinical development
of an additional product candidate, CBP-174 — a peripherally acting
antagonist of histamine receptor 3 — for the treatment of pruritus
associated with AD.
With clinical development activities in the United States,
China, Europe, and Australia, and operations in those geographies
as well as Hong Kong, 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 STATEMENTSConnect 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, competitive, or
favorable benefit or profile including with respect to safety,
efficacy and/or convenience, and the Company's plans to initiate a
Phase 3 trial program to further evaluate CBP-201. 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”). Among
other things, there can be no guarantee that planned or ongoing
studies will be initiated or completed as planned, that future
study results will be consistent with the results to date, that
CBP-201 will receive regulatory approvals, or be commercially
successful. 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.comCorporate
Contacts:info@connectpharm.com
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