Connect Biopharma Completes Enrollment of CBP-307 Global Phase 2 Clinical Trial in Moderate-to-Severe Ulcerative Colitis
November 19 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 it has completed full enrollment of the phase 2 clinical trial
evaluating CBP-307 in adult patients with moderate-to-severe
Ulcerative Colitis (UC).
This global, randomized, double-blind,
placebo-controlled phase 2 clinical trial is being conducted at
multiple sites, including in the U.S., to evaluate the efficacy and
safety of CBP-307 in 134 subjects, where CBP-307 or placebo is
expected to be administered to eligible adult subjects with
moderate-to-severe UC for 12 weeks (induction phase). Following
this 12-week induction phase, responders to treatment (as defined
by change in the adapted Mayo score from baseline) are expected to
be treated for a further 36 weeks in a double-blind manner, with
non-responders expected to enter an open-label arm and be treated
for an additional 36 weeks (maintenance phase). All enrolled
patients are expected to participate in a follow-up phase of 4
weeks following the end of the maintenance phase (NCT04700449).
“We are pleased to complete the enrollment of
the CBP-307 global phase 2 trial in patients with
moderate-to-severe UC, our lead clinical program for our oral S1P1
modulator,” said Zheng Wei, PhD, Co-Founder and CEO of Connect
Biopharma. “Despite the recent approval of oral therapies for the
treatment of UC, there remains the need for additional safe and
effective therapies, and we believe that CBP-307 has the potential
to address this unmet need. We look forward to announcing topline
results of the 12-week induction phase of this trial by the end of
the first quarter of 2022.”
About Ulcerative
ColitisUlcerative colitis (UC) is a common form of
inflammatory bowel disease (IBD) that causes chronic inflammation
of the large intestine. It is estimated that in 2015 there were 3.1
million U.S. adults with a diagnosis of IBD.1 As of 2016, UC
was slightly more prevalent than CD in North America.2
Current treatment options include
5-aminosalicylic acid preparations, systemic corticosteroids and
immunosuppressants, injectable biologics and surgery.3 While
these treatments provide benefit, significant unmet need remains.
We believe that CBP-307 has the potential to improve care outcomes
for patients with UC by providing improved safety, efficacy and
ease of administration compared with currently available
therapies.
About CBP-307CBP-307 is an
orally available, next generation small molecule modulator of the
sphingosine-1-phosphate 1 receptor (S1P1), a G-protein coupled
receptor (GPCR) that plays a central role in regulating T cell
movement out of lymph nodes and into the periphery and is a
validated therapeutic target. CBP-307 has been shown to be a highly
potent and selective modulator of S1P1 in in vitro preclinical
studies and has shown selectivity of over 80,000-fold in S1P1
versus S1P3. In two completed Phase 1 randomized, double blind,
placebo-controlled studies, CBP-307 exhibited an excellent safety
profile and potent T cell modulation activity as well as a
pharmacokinetic and pharmacodynamic profile consistent with once
daily dosing.
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 atopic dermatitis (AD),
asthma, and chronic rhinosinusitis with nasal polyps (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 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
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-307 to address
the unmet needs of patients with UC and/or the execution, size,
duration, and/or results of the phase 2 clinical trial evaluating
CBP-307. 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
planning or ongoing studies will be initiated or completed as
planned, that future study results will be consistent with the
results to date, that CBP-307 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.com
Erich Sandoval (Media)T:
+1-(917)-497-2867erich.sandoval@finnpartners.com
Corporate Contacts:info@connectpharm.com
References
- Dahlhamer JM,
Zammittie EP, Ward BW, et al. Prevalence of Inflammatory Bowel
Disease Among Adults Aged >18 Years – United States, 2015.
MMWR. 2016;65(42):1166-1169.
- Hanauer SB.
Advances in IBD. Gastroentrerology & Hepatology.
2016;12(11):704-707
- Kobayahsi T,
Siegmund B, Le Berre C, et al. Ulcerative Colitis. Nature Reviews:
Disease Primers. 2020;6:74.
Connect Biopharma (NASDAQ:CNTB)
Historical Stock Chart
From Mar 2024 to Apr 2024
Connect Biopharma (NASDAQ:CNTB)
Historical Stock Chart
From Apr 2023 to Apr 2024