Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology
company focused on developing novel therapeutics to treat severe
autoimmune and inflammatory disorders, today announced that Biocon
Limited, in collaboration with Equillium, has initiated a Phase 2
clinical study of itolizumab in patients with ulcerative colitis
(UC).
The Phase 2 double-blinded placebo-controlled clinical study is
evaluating the safety and efficacy of itolizumab for
biologics-naïve patients with moderate to severe active UC, where
patients are randomized 1:1:1 to receive a fixed dose of 140 mg of
itolizumab, adalimumab, or placebo every two weeks for a 12-week
treatment period, with adalimumab non-responders able to cross over
to itolizumab. The study is expected to enroll up to 90 patients in
multiple clinical trial sites in India. The trial design and
initiation have been a collaborative effort, with help from the
gastroenterologist community and leading global clinical and
scientific experts in the field of inflammatory bowel disease
(IBD).
“T cells play a pivotal role in the immune response that leads
to IBD and preclinical models show a role for CD6 in disease
pathogenesis,” said Dr. Maple Fung, senior vice president of
clinical development at Equillium. “As itolizumab has a novel dual
mechanism of action that modulates both the activity and
trafficking of CD6-expressing T effector cells, it is a promising
candidate for treatment of ulcerative colitis, where the severe
inflammation can be debilitating. Additional supportive rationale
can be found in our ongoing program investigating itolizumab in
severe acute graft-versus-host disease, where our Phase 1b EQUATE
study demonstrated meaningful complete responses, particularly in
those with lower gastroenterological symptoms. We’re excited to see
the UC study begin enrollment, as it may provide evidence of an
efficacy signal for the use of itolizumab in the treatment of
patients with ulcerative colitis.”
“We are encouraged by the progress being made on our high-value,
multi-indication molecule, itolizumab, in collaboration with
Equillium,” said Siddharth Mittal, managing director and chief
executive officer of Biocon Limited. “The commencement of the Phase
2 clinical study, that will provide data related to its efficacy as
a treatment of ulcerative colitis, is an important step forward in
our efforts to bring the potential benefit of itolizumab to
patients in India suffering from this disease. The development also
underpins Biocon’s commitment to bring innovative, affordable
medicines, that address unmet patient needs, to market
expeditiously.”
For more information on UC and Biocon’s clinical study of
itolizumab in UC, as well as queries to enroll in the study, please
write to ucp2_itoli_study.team@biocon.com.
About Itolizumab
Itolizumab is a clinical-stage, first-in-class anti-CD6
monoclonal antibody that selectively targets the CD6-ALCAM pathway.
This pathway plays a central role in modulating the activity and
trafficking of T cells that drive a number of immuno-inflammatory
diseases. Equillium acquired rights to itolizumab through an
exclusive partnership with Biocon Limited. Equillium has executed
an exclusive option and asset purchase agreement for the
development and commercialization of itolizumab with Ono
Pharmaceutical Co., Ltd.
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 immunomodulatory assets targeting
immuno-inflammatory pathways. Itolizumab, a first-in-class
monoclonal antibody that targets the CD6-ALCAM signaling pathway
which plays a central role in the modulation of effector T cells,
is currently in a Phase 3 study for patients with acute
graft-versus-host disease (aGVHD) and is in a Phase 1b study for
patients with lupus/lupus nephritis. EQ101 is a first-in-class
tri-specific cytokine inhibitor that selectively targets IL-2,
IL-9, and IL-15. Equillium is currently enrolling patients in a
Phase 2 proof-of-concept study of EQ101 for patients with alopecia
areata. EQ102 is a bi-specific cytokine inhibitor that selectively
targets IL-15 and IL-21. Equillium is currently enrolling patients
in a Phase 1 study of EQ102, including healthy volunteers and
celiac disease patients.
For more information, visit www.equilliumbio.com.
About Biocon Limited
Biocon Limited, publicly listed in 2004, (BSE code: 532523, NSE
Id: BIOCON, ISIN Id: INE376G01013) is an innovation-led, global
biopharmaceutical company committed to enhancing affordable access
to complex therapies for chronic conditions like diabetes, cancer
and autoimmune diseases. 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 and Europe. It also has a pipeline of promising novel assets
in immunotherapy under development. For more information, visit
www.biocon.com.
Additional Information and Where to Find It
This communication does not constitute an offer to sell or the
solicitation of an offer to buy any securities or a solicitation of
any vote or approval with respect to the proposed merger or
otherwise. No offer of securities shall be made except by means of
a prospectus meeting the requirements of Section 10 of the
Securities Act of 1933, as amended. In connection with Metacrine,
Inc.’s pending acquisition by Equillium, Inc., Equillium filed a
registration statement on Form S-4 (File No. 333-268024) containing
a joint proxy statement/prospectus of Equillium and Metacrine and
other documents concerning the proposed merger with the Securities
and Exchange Commission (the “SEC”). EQUILLIUM URGES
INVESTORS TO READ THE JOINT PROXY STATEMENT/PROSPECTUS AND THESE
OTHER MATERIALS CAREFULLY BECAUSE THEY CONTAIN IMPORTANT
INFORMATION ABOUT EQUILLIUM, METACRINE AND THE PROPOSED MERGER.
Investors may obtain free copies of the joint proxy
statement/prospectus and other documents filed by Equillium and
Metacrine with the SEC at the SEC’s website at www.sec.gov. Free
copies of the joint proxy statement/prospectus and Equillium’s
other SEC filings are also available on Equillium’s website at
www.equilliumbio.com.
Equillium, Metacrine and their respective directors, executive
officers, certain members of management and certain employees may
be deemed, under SEC rules, to be participants in the solicitation
of proxies with respect to the proposed merger. Information
regarding Equillium’s officers and directors is included in
Equillium’s Definitive Proxy Statement on Schedule 14A filed with
the SEC on April 13, 2022, with respect to its 2022 Annual Meeting
of Stockholders. This document is available free of charge at the
SEC’s website at www.sec.gov or by going to Equillium’s Investors
page on its corporate website at www.equilliumbio.com. Information
regarding Metacrine’s officers and directors is included in
Metacrine’s Definitive Proxy Statement on Schedule 14A filed with
the SEC on April 7, 2022, with respect to its 2022 Annual Meeting
of Stockholders. This document is available free of charge at the
SEC’s website at www.sec.gov or by going to Metacrine’s Investors
page on its corporate website at www.metacrine.com. Additional
information regarding the persons who may, under the rules of the
SEC, be deemed participants in the solicitation of proxies in
connection with the proposed Merger, and a description of their
direct and indirect interests in the proposed Merger, which may
differ from the interests of Equillium’s stockholders or
Metacrine’s stockholders generally, will be set forth in the joint
proxy statement/prospectus when it is filed with the SEC.
Forward Looking Statements
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” and
"project" and other similar expressions that predict or indicate
future events or trends or that are not statements of historical
matters. Because such statements are subject to risks and
uncertainties, many of which are outside of the Company’s control,
actual results may differ materially from those expressed or
implied by such forward-looking statements. Such statements
include, but are not limited to statements regarding the potential
benefits and risks of the transactions contemplated by the option
and asset purchase agreement entered into by the Company and Ono,
including the possibility that Ono does not exercise the option,
the Company receives no further payments under the option and asset
purchase agreement other than those payable upon signing, the
possibility that, if commercialized, itolizumab proves to be more
valuable than contemplated by the option and asset purchase
agreement, the fluctuation of the foreign exchange rate, the
benefit of treating patients with aGVHD or lupus/lupus nephritis
with itolizumab, Equillium’s plans and expected timing for
developing itolizumab including the expected timing of initiating,
completing and announcing further results from the EQUATOR, EQUATE
and EQUALISE studies, Equillium’s plans and expected timing for
developing EQ101 and EQ102 including the expected timing of
initiating, completing and announcing further results from Phase 2
and Phase 1 studies, respectively, the potential for any of
Equillium’s ongoing or planned clinical studies to show safety or
efficacy, Equillium’s anticipated timing of regulatory review and
feedback, Equillium’s cash runway, and Equillium’s plans and
expected timing for developing its product candidates and potential
benefits of its product candidates. Risks that contribute to the
uncertain nature of the forward-looking statements include:
uncertainties related to the abilities of the leadership team to
perform as expected; Equillium’s ability to execute its plans and
strategies; risks related to performing clinical studies; the risk
that interim results of a clinical study do not necessarily predict
final results and that one or more of the clinical outcomes may
materially change as patient enrollment continues, following more
comprehensive reviews of the data, and as more patient data become
available; potential delays in the commencement, enrollment and
completion of clinical studies and the reporting of data therefrom;
the risk that studies will not be completed as planned; Equillium’s
plans and product development, including the initiation and
completion of clinical studies and the reporting of data therefrom;
whether the results from clinical studies will validate and support
the safety and efficacy of Equillium’s product candidates; risks
related to Ono’s financial condition, willingness to continue to
fund the development of itolizumab, and decision to exercise its
option to purchase itolizumab or terminate the option and asset
purchase agreement; changes in the competitive landscape;
uncertainties related to Equillium’s capital requirements; and
having to use cash in ways or on timing other than expected and the
impact of market volatility on cash reserves. 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 EDGAR on the SEC web site at
http://www.sec.gov and on the Company’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.
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version on businesswire.com: https://www.businesswire.com/news/home/20221216005090/en/
Investor & Media Contact Equillium, Inc. Michael
Moore Vice President, Investor Relations Officer & Head of
Corporate Communications 619-302-4431 ir@equilliumbio.com
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