Phase 2 proof-of-concept study evaluating EQ101
efficacy, safety, tolerability and PK/PD in subjects with alopecia
areata over 24 weeks of treatment
EQ101 targets IL-2, IL-9, and IL-15, key
cytokines known to be upregulated in alopecia areata, and therefore
may provide a more selective and potent approach to disease
treatment
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 2 open-label study of
EQ101 to assess efficacy and safety in adult subjects with moderate
to severe alopecia areata. The study is expected to enroll
approximately 30 subjects at multiple clinical sites in
Australia.
This is a proof-of-concept study in adult subjects with at least
35% scalp hair loss due to alopecia areata (AA) where EQ101 will be
administered intravenously once weekly over 24 weeks at a dose
level of 2 mg/kg, with follow-up for an additional four weeks. The
objectives of the study are to evaluate the efficacy, safety,
tolerability, and pharmacokinetic/pharmacodynamic (PK/PD)
properties of EQ101 in adult subjects with moderate to severe
AA.
“We are pleased to announce another major milestone as we
initiate this proof-of-concept study of EQ101 in alopecia areata
and now have both of our multi-cytokine inhibitors we acquired
earlier this year in the clinic,” said Bruce Steel, chief executive
officer at Equillium. “EQ101 is a first-in-class, tri-specific
cytokine inhibitor selectively targeting IL-2, IL-9 and IL-15 at
the receptor level, that may afford significant advantages over
other treatment approaches, including JAK inhibition. We recently
presented data at the Sixth Annual Dermatology Drug Development
Summit outlining that EQ101 demonstrated more effective hair
regrowth and suppression of cytotoxic CD8+ T-cells than ruxolitinib
in a mouse model of immune-mediated hair loss. We believe this
study will benefit from strong enrollment support and look forward
to presenting data from this study next year.”
“Alopecia areata is one of the most common auto-immune diseases
in man with a lifetime risk of two percent. Despite the significant
psychosocial distress experienced by patients with AA, there are
still very few treatment options,” said Dr. Rodney Sinclair,
Professor of Medicine at the University of Melbourne and Director
of Sinclair Dermatology and principal investigator for the EQ101 AA
study. “EQ101 specifically targets IL-2, IL-9 and IL-15, which are
key cytokines implicated in the pathogenesis of AA. The mechanism
of action has the potential to produce fewer side effects than
recently approved treatments for this disease. I am excited to see
the presentation of pre-clinical and translational data of EQ101
targeting alopecia areata at the World Congress for Hair Research
2022 in Melbourne, Australia later this month, and to lead this
Phase 2 study of EQ101 in AA, from which we hope to have clinical
data in 2023.”
A previous Phase 1/2 proof-of-concept study in cutaneous T cell
lymphoma (CTCL) demonstrated that EQ101 was safe and well
tolerated, and treatment resulted in clinically meaningful
improvement in skin scores. The differentiated approach of EQ101 to
block multiple cytokines (IL-2, IL-9 & IL-15) of the common
gamma chain receptor that are known to be upregulated in animal
models and human biopsies of alopecia areata may provide a more
selective and potent approach to treatment than direct JAK
inhibition, and may position EQ101 as an attractive alternative to
JAK inhibitors.
About the Phase 2 Study of EQ101
This is a multicenter, open-label, proof-of-concept Phase 2
study in approximately 30 adult subjects between 18 and 60 years of
age, with at least 35% scalp hair loss due to alopecia areata (AA).
Subjects will be dosed intravenously once weekly for 24 weeks with
EQ101 at a dose level of 2 mg/kg, and subsequently followed for an
additional four weeks. The primary objective of the study is to
evaluate the safety and tolerability of EQ101 in subjects with
moderate to severe AA over a 24-week treatment period; secondary
objectives will be to evaluate drug efficacy,
pharmacokinetic/pharmacodynamic (PK/PD) properties, and to assess
changes in patient biomarkers.
About Alopecia Areata
Alopecia areata (AA) is a common, inflammatory, non-scarring
condition resulting in hair loss that occurs when the immune system
attacks hair follicles on any hair-bearing area of the body, most
frequently on the head and face. The lifetime incidence of AA is
estimated at about two percent globally, affecting men and women of
all racial and ethnic groups. It has a higher prevalence in
children and adolescents with 40% of cases occurring prior to age
20, and 80% before age 40. AA is associated with other
immune-mediated or autoimmune disorders such as thyroiditis,
vitiligo, and atopic diseases. Approximately 50% of patients have
chronic relapsing, remitting disease persisting more than 12 months
and approximately 10% to 35% ultimately experience complete loss of
scalp hair (alopecia totalis, or AT) or complete loss of scalp and
body hair (alopecia universalis, or AU). AA has a significant
psychosocial burden that can have a significant negative impact on
health-related quality of life and has been associated with
depression and anxiety.
There are currently limited treatment options and few countries
have approved drugs for the treatment of AA. IL-2, IL-9, and IL-15
are cytokines of the common gamma chain receptor known to be
upregulated in animal models and human biopsies of alopecia areata
and may provide a selective and potent approach to disease
treatment.
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 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.
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 for developing EQ101 and EQ102, including the
expected timing of presenting topline data from the Phase 2 study
of EQ101, the potential for any of Equillium’s ongoing or planned
clinical studies to show safety or efficacy, 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20221110005503/en/
Michael Moore Vice President, Investor Relations & Corporate
Communications 619-302-4431 ir@equilliumbio.com
Equillium (NASDAQ:EQ)
Historical Stock Chart
From Aug 2024 to Sep 2024
Equillium (NASDAQ:EQ)
Historical Stock Chart
From Sep 2023 to Sep 2024