Equillium Announces Interim Enrollment Achieved in Phase 3 EQUATOR Study of Itolizumab in Acute Graft-Versus-Host Disease
14 Maggio 2024 - 2:00PM
Business Wire
More than 100 patients enrolled from over 100
clinical trial sites active in 12 countries
Delivery of the interim data review to Ono
Pharmaceutical Co. Ltd. (Ono) expected during Q3 will trigger Ono’s
option exercise period
Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology
company focused on developing novel therapeutics to treat severe
autoimmune and inflammatory disorders, today announced that it has
surpassed the interim enrollment target for the Phase 3 EQUATOR
study of itolizumab in acute graft-versus-host disease (aGVHD).
Equillium expects to deliver the results of the EQUATOR interim
data review to Ono during the third quarter, which will then
trigger Ono’s three-month option exercise period to acquire
Equillium’s rights to itolizumab.
“Our clinical development team has done an excellent job of
recruiting and activating trial sites globally,” said Bruce Steel,
chief executive officer at Equillium. “While the interim data will
be blinded to Equillium and Ono, our independent data monitoring
committee will conduct an unblinded analysis of the data and make a
recommendation whether the study should proceed to conclusion based
on pre-determined futility and efficacy stopping boundaries. Having
now met the enrollment threshold for the interim review, we believe
we are well on track to meet our guidance of delivering this final
data milestone to Ono during the third quarter, setting the
timeline for Ono’s option exercise decision to acquire itolizumab,
which will expire three months following delivery of the results of
the interim analysis.”
If Ono exercises the option, Ono will pay Equillium a one-time
payment of JPY 5.0 billion, or approximately $32.2 million based on
the currency exchange rate on May 8, 2024. Equillium is also
eligible to receive up to $101.4 million upon the achievement of
certain development, regulatory, and commercialization
milestones.
About the EQUATOR Study
The Phase 3, randomized, double-blind, placebo-controlled
multicenter study (NCT05263999) will compare the efficacy and
safety of IV administered itolizumab versus placebo (randomized
1:1) as a first-line therapy in approximately 200 adult and
adolescent patients with Grade III-IV aGVHD, or Grade II aGVHD with
lower GI involvement, in combination with high doses of
corticosteroids, the current standard of care. The primary study
endpoint is complete response rate at Day 29; key secondary
endpoints include overall response rate at Day 29 and durability of
complete response rate from Day 29 through Day 99.
Per the study protocol, patients must receive itolizumab within
3-days of the first administration of high-dose corticosteroids
with a treatment period from Days 1-99, and a follow-up period from
Days 100-365. Approximately 200 eligible subjects will receive 2
mg/kg methylprednisolone or equivalent on Day 1 and will be
randomized in a 1:1 ratio to the following two treatment
groups:
- Group A: Itolizumab, 1.6 mg/kg initial dose followed by 6 doses
of 0.8 mg/kg once every 2 weeks (q2w), plus systemic
corticosteroids (100 subjects)
- Group B: Placebo, 7 doses q2w, plus systemic corticosteroids
(100 subjects)
An independent data monitoring committee will regularly review
safety data, and an interim analysis for both futility and efficacy
will be conducted after approximately 100 subjects have completed
Day 29 assessments.
About Itolizumab
Itolizumab is a clinical-stage, first-in-class anti-CD6
monoclonal antibody that selectively targets the CD6-ALCAM
signaling pathway to selectively 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.
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. EQ101: a selective
tri-specific cytokine inhibitor targeting IL-2, IL-9, and IL-15;
currently under evaluation in a Phase 2 proof-of-concept clinical
study of patients with alopecia areata being conducted in Australia
and New Zealand by Equillium’s Australian subsidiary as the trial
sponsor. EQ302: an orally delivered, selective bi-specific cytokine
inhibitor targeting IL-15 and IL-21; currently in pre-clinical
development. The multi-cytokine platform: generates rationally
designed composite peptides that selectively block key cytokines at
the shared receptor level targeting pathogenic cytokine
redundancies and synergies while preserving non-pathogenic
signaling. Itolizumab: a monoclonal antibody that targets the
CD6-ALCAM signaling pathway which plays a central role in the
modulation of effector T cells; currently under evaluation in a
Phase 3 clinical study of patients with acute graft-versus-host
disease (aGVHD) and recently completed a Phase 1b clinical study of
patients with lupus/lupus nephritis. Equillium acquired rights to
itolizumab through an exclusive partnership with Biocon Limited and
has entered a strategic partnership with Ono Pharmaceutical Co.,
Ltd., for the development and commercialization of itolizumab under
an option and asset purchase agreement.
For more information, visit www.equilliumbio.com.
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. These statements include, but are not limited to,
statements regarding Equillium’s plans to deliver the results of
the interim review of the EQUATOR study to Ono Pharmaceutical and
related timing thereof, the timing for triggering Ono’s option
period and for receiving Ono’s option decision, plans for
developing EQ101, EQ302 and itolizumab, the expected timeline for
results from clinical studies, anticipated upcoming milestones, the
fluctuation of the foreign exchange rate, 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; Equillium’s plans and
product development, including the initiation and completion of
clinical studies and the reporting of data therefrom; changes in
the competitive landscape; risks related to Ono’s financial
condition and decision to exercise its option, if ever, to purchase
itolizumab or terminate the asset purchase agreement; and
uncertainties related to Equillium’s capital requirements. 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20240514537675/en/
Investor Michael Moore Vice President, Investor Relations
& Corporate Communications 619-302-4431 ir@equilliumbio.com
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