Itolizumab demonstrated clinical efficacy after
12 weeks of treatment, achieving a clinical remission rate of 23.3%
compared to 20.0% for adalimumab and 10.0% for placebo
Itolizumab achieved key secondary endpoint of
endoscopic remission of 16.7% compared to 16.7% for adalimumab and
6.7% for placebo
Itolizumab was generally well tolerated
consistent with prior clinical experience
Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology
company leveraging a deep understanding of immunobiology to develop
novel therapeutics to treat severe autoimmune and inflammatory
disorders, and Biocon Limited (BSE code: 532523, NSE: BIOCON), an
innovation-led global biopharmaceutical company, today announced
positive topline results from the Phase 2 study evaluating
itolizumab in the treatment of moderate to severe ulcerative
colitis (UC).
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The double-blinded, placebo- and active-controlled Phase 2
clinical study evaluated the safety and efficacy of itolizumab in
biologic-naïve patients with moderate to severe active UC. A total
of 90 patients were randomized 1:1:1 to receive itolizumab (fixed
dose of 140 mg), placebo, or adalimumab (a global standard of care
biologic treatment used as an active control) every two weeks for
an initial 12-week treatment period. The primary endpoint of the
study was clinical remission as defined by Total Mayo Score, and
secondary endpoints included the proportion of participants who
achieved clinical response and endoscopic remission (evaluated by
central endoscopy). The study was co-sponsored by Equillium and
Biocon Limited and conducted at multiple clinical trial sites in
India. The design and conduct of the trial were a collaborative
effort, with input from the gastroenterology community and leading
global clinical and scientific experts in the field of inflammatory
bowel disease (IBD).
“The CD6-ALCAM pathway is elevated in gastrointestinal
inflammation and is associated with severity of disease in both
ulcerative colitis and Crohn’s patients. As such, we are delighted
with the strength of data across the primary and secondary
endpoints of this Phase 2 study in moderate to severe ulcerative
colitis patients,” said Dr. Stephen Connelly, chief scientific
officer at Equillium. “Itolizumab was well tolerated and achieved a
clinical remission rate of 23 percent despite an imbalance of more
severe patients in the itolizumab arm compared to the other arms of
the study. While these positive results add to itolizumab’s
critical mass of safety and efficacy data across different patient
populations, we are particularly encouraged by this data in the
context of our Phase 3 EQUATOR study in acute graft-versus-host
disease, where lower gastrointestinal pathogenesis is a key driver
of mortality, with topline data expected this quarter.”
“Itolizumab demonstrated proof of concept with a meaningful
effect size – comparable to biologic standard of care adalimumab –
in this Phase 2 study in subjects with moderate to severe
ulcerative colitis,” said Dr. Brian Feagan, Professor of Medicine
at the Schulich School of Medicine & Dentistry at the
University of Western Ontario. “Itolizumab represents a novel
selective immune modifying mechanism of action with great potential
in a treatment paradigm needing differentiation and improved
outcomes for patients.”
Summary of Key Study Results
Baseline demographics of the study included a median age of 39
years, relatively equal proportions of male and female subjects
evenly distributed among study arms, and a mean weight of 58
kilograms.
Baseline disease severity of the study was greater in the
itolizumab arm, where 23% of patients were classified as severe
(Total Mayo Score of 11) versus 0% in the placebo and adalimumab
arms, and 66% had left-sided colitis versus 30% and 43% in the
placebo and adalimumab arms, respectively.
The primary endpoint of the study was clinical remission,
defined as Total Mayo Score of ≤ 2 with no individual sub-score
greater than 1 at Week 12. Secondary endpoints included the
proportion of participants who achieved clinical response (per
Total Mayo Score) and endoscopic remission (evaluated by central
endoscopy) at Week 12 and Week 24. Additional data is expected to
be presented at a future scientific conference during 2025.
- 23.3% clinical remission in the itolizumab arm at 12 weeks
(primary endpoint) vs. 20.0% in adalimumab* vs. 10.0% in
placebo
- 63.3% clinical response in the itolizumab arm at 12 weeks vs.
60.0% in adalimumab vs. 46.7% in placebo
- 16.7% endoscopic remission in the itolizumab arm at 12 weeks
vs. 16.7% in adalimumab vs. 6.7% in placebo
- Itolizumab was generally well tolerated, and no safety signal
was observed
* One patient from the adalimumab arm had ‘endoscopic
remission,’ but was recorded as ‘not in clinical remission’ at week
12 due to missing sub-score data
About Itolizumab
Itolizumab is a clinical-stage, first-in-class immune-modifying
monoclonal antibody that selectively targets the CD6-ALCAM
signaling pathway to downregulate pathogenic T effector cells while
preserving T regulatory cells critical for maintaining a balanced
immune response. This pathway plays a central role in modulating
the activity and trafficking of T cells that drive a number of
immuno-inflammatory diseases.
The blockade of CD6 with itolizumab has demonstrated a reduction
in T effector cell proliferation and downregulation of several
important pathways that contribute to T effector cell development.
The downregulation of these pathways is accompanied by decreased
secretion of the pro-inflammatory T effector cytokines IFN-γ,
TNF-α, IL-6 and IL-17. Additionally, inhibiting the binding of
ALCAM to CD6 modulates lymphocyte trafficking and results in
reduced T effector cell infiltration into inflamed tissues.
About Biocon Limited
Biocon Limited, publicly listed in 2004, (BSE code: 532523, NSE
Id: BIOCON, ISIN Id: INE376G01013) is an innovation-led global
biopharmaceuticals company committed to enhance affordable access
to complex therapies for chronic conditions like diabetes, cancer
and autoimmune. It has developed and commercialized novel
biologics, biosimilars, and complex small molecule APIs in India
and several key global markets as well as Generic Formulations in
the US, Europe & key emerging markets. It also has a pipeline
of promising novel assets in immunotherapy under development.
Website: www.biocon.com; Follow-us on Twitter: @bioconlimited for
company updates.
About Equillium
Equillium is a clinical-stage biotechnology company leveraging a
deep understanding of immunobiology to develop novel therapeutics
to treat severe autoimmune and inflammatory disorders with high
unmet medical need. The company’s pipeline consists of the
following novel first-in-class immunomodulatory assets and product
platform targeting immuno-inflammatory pathways. Itolizumab: a
monoclonal antibody that targets the CD6-ALCAM signaling pathway
which plays a central role in the modulation of effector T cells
that drive a number of immuno-inflammatory diseases. It is
currently under evaluation in a Phase 3 clinical study of patients
with acute graft-versus-host disease (aGVHD) and has exhibited
positive data from both a Phase 2 clinical study of patients with
moderate to severe ulcerative colitis and a Phase 1b clinical study
of patients with lupus/lupus nephritis. Equillium acquired rights
to itolizumab through an exclusive partnership with Biocon Limited,
who also provides commercial manufacturing for the product. EQ101:
a selective tri-specific cytokine inhibitor targeting IL-2, IL-9,
and IL-15, has exhibited positive results in both a Phase 2
proof-of-concept clinical study of patients with moderate to severe
alopecia areata and a Phase 1/2 proof-of-concept clinical study of
patients with cutaneous T cell lymphoma (CTCL). EQ302: an orally
delivered, selective bi-specific cytokine inhibitor targeting IL-15
and IL-21 at pre-clinical stage.
For more information, visit www.equilliumbio.com.
Forward-Looking Statements
Equillium
Statements contained in this press release regarding matters
that are not historical facts are “forward-looking statements”
within the meaning of the Private Securities Litigation Reform Act
of 1995. Forward-looking statements may be identified by the use of
words such as “anticipate”, “believe”, “could”, “continue”,
“expect”, “estimate”, “may”, “plan”, “outlook”, “future”,
“potential” and “project” and other similar expressions that
predict or indicate future events or trends or that are not
statements of historical matters. These statements include, but are
not limited to, statements regarding Equillium’s plans and
strategies with respect to developing itolizumab, the encouraging
impact of the positive data in the context of Equillium’s Phase 3
EQUATOR study in aGVHD, the expected timeline for the presentation
of additional data from the Phase 2 study of itolizumab in UC, and
the potential benefits of Equillium’s product candidates. Because
such statements are subject to risks and uncertainties, many of
which are outside of Equillium’s control, actual results may differ
materially from those expressed or implied by such forward-looking
statements. Risks that contribute to the uncertain nature of the
forward-looking statements include: Equillium’s ability to execute
its plans and strategies; risks related to performing clinical and
pre-clinical studies; whether the results from clinical and
pre-clinical studies will validate and support the safety and
efficacy of Equillium’s product candidates; changes in the
competitive landscape; and changes in Equillium’s strategic plans.
These and other risks and uncertainties are described more fully
under the caption "Risk Factors" and elsewhere in Equillium's
filings and reports, which may be accessed for free by visiting the
Securities and Exchange Commission’s website and on Equillium’s
website under the heading “Investors.” Investors should take such
risks into account and should not rely on forward-looking
statements when making investment decisions. All forward-looking
statements contained in this press release speak only as of the
date on which they were made. Equillium undertakes no obligation to
update such statements to reflect events that occur or
circumstances that exist after the date on which they were made,
except as required by law.
Biocon
This press release may include statements of future expectations
and other forward-looking statements based on management's current
expectations and beliefs concerning future developments and their
potential effects upon Biocon and its subsidiaries/ associates.
These forward-looking statements involve known or unknown risks and
uncertainties that could cause actual results, performance or
events to differ materially from those expressed or implied in such
statements. Important factors that could cause actual results to
differ materially from our expectations include, amongst other:
general economic and business conditions in India and overseas, our
ability to successfully implement our strategy, our research and
development efforts, our growth and expansion plans and
technological changes, changes in the value of the Rupee and other
currency changes, changes in the Indian and international interest
rates, change in laws and regulations that apply to the Indian and
global biotechnology and pharmaceuticals industries, increasing
competition in and the conditions of the Indian and global
biotechnology and pharmaceuticals industries, changes in political
conditions in India and changes in the foreign exchange control
regulations in India. Neither Biocon, nor our Directors, nor any of
our subsidiaries/associates assume any obligation to update any
particular forward-looking statement contained in this release.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20250206241338/en/
Corporate Contact Michael Moore Vice President, Investor
Relations & Corporate Communications 619-302-4431
ir@equilliumbio.com
Biocon Limited Saurabh Paliwal Head – Investor Relations
+91 9538380801 saurabh.paliwal@biocon.com
Biocon Limited Calvin Printer Head – Corporate
Communications +91 7032969537 Calvin.printer@biocon.com
Equillium (NASDAQ:EQ)
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