Equillium Announces Initiation of Phase 1 study of EQ102, A First-in-Class Multi-Cytokine Inhibitor of IL-15 and IL-21 Targeting Celiac Disease
November 02 2022 - 8:00AM
Business Wire
Phase 1 study evaluating safety,
tolerability and PK/PD after single and multiple ascending doses in
healthy volunteers and biological activity in subjects with celiac
disease
Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology
company focused on developing novel therapeutics to treat severe
autoimmune and inflammatory disorders with high unmet medical need,
today announced that it has initiated a Phase 1 study of EQ102 in
healthy volunteers, completed dosing of the initial cohort of eight
study participants and begun dosing the second cohort.
The single ascending dose/multiple ascending dose (SAD/MAD)
study is a randomized, double-blind, placebo-controlled study of
EQ102 administered subcutaneously as single or multiple doses in up
to 64 healthy volunteers. The primary endpoint of the study is to
assess the safety and tolerability of EQ102 with secondary
endpoints to assess pharmacokinetic and pharmacodynamic (PK/PD)
changes. Following the SAD/MAD portion of this study Equillium
plans to evaluate the biological activity of EQ102 in subjects with
celiac disease.
“This marks a major milestone as the first human study of EQ102,
a therapeutic candidate generated de novo from our multi-cytokine
inhibitor platform,” said Bruce Steel, chief executive officer at
Equillium. “EQ102 inhibits the natural biological synergy of
cytokines IL-15 and IL-21 that drive cytotoxic T cell responses in
gastrointestinal inflammation. We believe this may be an optimal
approach to treating patients with celiac disease, and we look
forward to reporting initial clinical data from this study next
year.”
“Patients with celiac disease are unfortunately still without an
effective therapy to treat their debilitating symptoms and it
remains one of the most underserved conditions globally,” said Bana
Jabri, M.D., Ph.D., professor of medicine, vice-chair for research
in the Department of Medicine at the University of Chicago School
of Medicine, and director of research at the University of Chicago
Celiac Disease Center. “There is strong evidence that increased
levels of the cytokines IL-15 and IL-21 synergize to promote
cytotoxic activity of immune cells leading to inflammation and
villous atrophy in intestinal tissues of patients with celiac
disease. I’m encouraged by the strong pre-clinical and
translational data for EQ102 and believe this novel approach and
dual-targeting of IL-15 and IL-21 is very well aligned to treat
gastrointestinal inflammation in celiac disease and look forward to
seeing results from this study.”
EQ102 has been shown to inhibit both IL-15 and IL-21 induced
signaling pathways in celiac patient-derived intraepithelial
cytotoxic T-Lymphocytes and key genes for tissue destruction in
patient-derived organoid cultures. Similarly, in pre-clinical
studies, EQ102 has demonstrated the prevention of intestinal tissue
damage in a humanized mouse model of gastrointestinal
inflammation.
About the Phase 1 Study of EQ102
This is a Phase 1 randomized, double-blind, placebo-controlled
study of EQ102 administered subcutaneously as single or multiple
doses in up to 64 normal healthy volunteers. In Part A, healthy
volunteers will be enrolled and randomized to five cohorts (n=8 per
cohort) to receive single ascending doses of EQ102 or placebo. In
Part B, healthy volunteers will be enrolled and randomized to three
cohorts (n=8 per cohort) to receive multiple ascending doses (MAD)
of EQ102 or placebo. The starting dose in Part A will be 50mg with
five ascending dose levels planned up to 1,000mg. In Part B, up to
three dose levels will be evaluated in healthy volunteers, where
the starting dose will be based on safety and pharmacokinetic data
from Part A. The primary endpoint of the study is to assess the
safety and tolerability of EQ102 after single and multiple
ascending subcutaneous doses. Secondary endpoints include the
assessment of pharmacokinetic/pharmacodynamic changes after single
and multiple ascending doses. Following the MAD portion of this
study, Part C of the study will evaluate the biological activity of
EQ102 in subjects with celiac disease.
About Celiac Disease
Celiac Disease (CeD), with an estimated global incidence of over
50 million patients, is a chronic inflammatory intestinal disorder
caused by an inappropriate immune response to the dietary intake of
gluten. It occurs selectively in individuals expressing human
leukocyte antigen (HLA)-DQ2 or HLA-DQ8, and results in a mucosal
inflammatory response in the intestine. The loss of mucosal
integrity in CeD is associated with a high burden of illness
resulting from a large number of intestinal and extra-intestinal
disease manifestations. Currently, there are no approved treatments
and a strict adherence to a gluten-free diet is the only approach
for CeD patients to manage the disease. A full recovery is often
observed in pediatric CeD patients, but greater than 40% of adult
CeD patients maintain histological abnormalities following complete
removal of dietary gluten. A significant body of evidence
implicates the roles of IL-15 and IL-21 in the pathoetiology of
CeD.
About Multi-Cytokine Platform: EQ101 & EQ102
Our proprietary Multi-Cytokine Platform (MCP) 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. This approach provides multi-cytokine inhibition at the
receptor level and is expected to avoid the broad
immuno-suppression and off-target safety liabilities that may be
associated with other therapeutic classes, such as JAK inhibitors.
Many immune-mediated diseases are driven by the same combination of
dysregulated cytokines, and we believe identifying the key
cytokines for these diseases will allow us to target and develop
customized treatment strategies for multiple autoimmune and
inflammatory diseases.
Current MCP assets include EQ101, a first-in-class, selective,
tri-specific inhibitor of IL-2, IL-9 and IL-15, and EQ102, a
first-in-class, selective, bi-specific inhibitor of IL-15 and
IL-21.
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 expects to begin enrolling patients in
an alopecia areata Phase 2 study of EQ101 in the fourth quarter of
2022. 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.
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 of using our multi-cytokine platform to develop treatments
for patients with certain autoimmune and inflammatory diseases,
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, 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; 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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Investor Contact Michael Moore Vice President, Investor
Relations & Corporate Communications 619-302-4431
ir@equilliumbio.com
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