Equillium Announces Data from Phase 1b EQUALISE Study Presented at the 2023 Annual Meeting of the American Society of Nephrology
November 06 2023 - 7:00AM
Business Wire
Itolizumab continues to show clinically
meaningful response in highly proteinuric subjects
At Week 28, 73% of subjects achieved >50%
reduction in urine protein creatinine ratio (UPCR)
Itolizumab demonstrated a favorable safety and
tolerability profile
Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology
company focused on developing novel therapeutics to treat severe
autoimmune and inflammatory disorders, today announced that data
from the Type B portion of the EQUALISE study in lupus nephritis
patients was presented at the annual meeting of the American
Society of Nephrology (ASN). The data highlights that subjects had
high complete and partial response rates with rapid and deep
reduction in urine protein creatinine ratio (UPCR) when itolizumab
was added to mycophenolate mofetil (MMF) and corticosteroids.
“The presentation at ASN represents current data from the
EQUALISE study, which includes all but the last patient in the
follow up period,” said Bruce Steel, chief executive officer at
Equillium. “We are encouraged that we continue to see clinically
meaningful response rates, particularly in these highly proteinuric
subjects. While the study is largely complete, we plan to deliver
the full data package to Ono Pharmaceutical under the terms of our
strategic partnership in early 2024.”
“I’m excited that we saw both early and deep reductions in
proteinuria,” said Dr. Maple Fung, chief medical officer at
Equillium. “Physicians are looking for a treatment that can safely
and rapidly reduce the levels of proteinuria in patients, as this
is historically associated with improved long-term outcomes. The
data from the EQUALISE study demonstrates that subjects had high
complete and partial response rates and tolerated well the
subcutaneous injections every two weeks; this is in the setting of
tapering their systemic corticosteroids, maintaining stable kidney
function, or eGFR, and increasing serum albumin while on
study.”
The Type B portion of the EQUALISE study in patients with active
proliferative LN (apLN) is evaluating the safety, tolerability and
clinical activity of subcutaneous delivery of itolizumab. Patients
must present with greater than 1 gram of proteinuria and have a
recent kidney biopsy showing ISN/RPS class III or IV apLN to be
eligible for the study. During the 24-week treatment period,
patients receive a subcutaneous dose of 1.6 mg/kg every two weeks,
with follow up out to 36 weeks. Consistent with standard of care,
patients on study also receive 2-3 g/day of mycophenolate
mofetil/mycophenolic acid (MMF/MPA), and patients may receive pulse
systemic corticosteroids that are rapidly tapered.
A total of 17 subjects have been enrolled in the study, with 15
subjects reaching Week 28 (4 weeks following the final dose, or the
end of study (EOS)). Based on published guidelines for the
management of lupus nephritis from the European League Against
Rheumatism (EULAR) and European Renal Association-European Dialysis
and Transplant Association (ERA-EDTA), clinical activity
assessments in this study are focused on the change in UPCR from
baseline; proportion of apLN subjects with a complete response
(CR), defined as 50% or greater reduction in UPCR and less than
0.5-0.7 g/g; and proportion of subjects achieving a partial
response (PR), defined as 50% or greater reduction in UPCR.
Key findings from analysis of the Type B portion of the
EQUALISE study in lupus nephritis:
- Subjects were highly proteinuric: baseline mean UPCR of 4.9
g/g
- Percent reduction from baseline in median spot UPCR is
~73%
- Clinically meaningful responses were observed:
- By week 28 (EOS):
- 6 of 15 (40%) subjects achieved CR (UPCR < 0.7 g/g)
- Additional 5 of 15 (33%) subjects achieved PR (UPCR
> 50% reduction)
- There was a greater overall response rate (ORR) achieved in
patients receiving itolizumab by 12 and 28 weeks than expected
compared to the ORR in patients receiving standard of care alone
using data generated from the Accelerating Medicines Partnership®
(AMP) Lupus Network. Results are comparable to those observed in
the Phase 3 AURORA1 study of voclosporin (ORR 70% at 6 and 12
months in active treatment).
- Consistent with the decline in UPCR overtime, subjects were
able to taper their systemic corticosteroids over the course of the
study.
- Itolizumab induced consistent pharmacodynamic responses in
patients reducing the levels of cell surface CD6 on T cells, which
is known to reduce T cell activity.
- Itolizumab treatment (over 6 months) was also associated with
reductions in absolute lymphocyte counts (ALC), another known
pharmacodynamic effect.
- As noted in other studies of drugs whose mechanism leads to
reductions in ALC, such as the S1P modulators, the reduction in ALC
observed here was not associated with increased rates of infection
or other adverse clinical signals.
- 77% of TEAEs were assessed as mild (Grade 1) or moderate (Grade
2) by the investigators. Two subjects had at least one serious
adverse event.
The poster presentation is available on the Presentations page
of Equillium’s website under the Lupus tab.
About Systemic Lupus Erythematosus (SLE) & Lupus Nephritis
(LN)
SLE is an autoimmune disease in which the immune system attacks
its own tissues, causing widespread inflammation and tissue damage
in the affected organs. It can affect the joints, skin, brain,
lungs, kidneys, and blood vessels. LN is a serious complication of
SLE, occurring in approximately 30% – 60% of individuals with SLE.
LN involves the body’s own immune system attacking the kidneys,
causing inflammation and significantly reducing kidney function
over time. LN is associated with an increase in mortality compared
with the general population and may lead to end-stage renal
disease.
About the EQUALISE Study
The EQUALISE study is a two-part Phase 1b open-label
proof-of-concept study of itolizumab in patients with SLE and LN.
The Type A portion of the study was a multiple ascending-dose
clinical study evaluating the safety and tolerability of
subcutaneous delivery of itolizumab over a two-week treatment
period in 35 patients with SLE. The Type B portion of the study, is
evaluating the safety, tolerability and clinical activity of
subcutaneous delivery of itolizumab dosed at 1.6 mg/kg every two
weeks over a 24-week treatment period in patients with active
proliferative LN.
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 targeting
immuno-inflammatory pathways. EQ101: a tri-specific cytokine
inhibitor that selectively targets IL-2, IL-9, and IL-15; currently
under evaluation in a Phase 2 proof-of-concept clinical study of
patients with alopecia areata. EQ102: a bi-specific cytokine
inhibitor that selectively targets IL-15 and IL-21; currently under
evaluation in a Phase 1 first-in-human clinical study to include
healthy volunteers and celiac disease patients. EQ302: an
orally-delivered, bi-specific inhibitor of IL-15 and IL-21;
currently in preclinical development. 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 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 plan to deliver full data package
from its EQUALISE study to Ono Pharmaceuticals in early 2024, the
potential benefits of itolizumab as a treatment for SLE and LN; and
other statements regarding management’s intentions, plans, beliefs
or expectations for the future. 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; 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;
changes in the competitive landscape; 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 at www.sec.gov 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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Investor Contact Michael Moore Vice President, Investor
Relations & Corporate Communications 619-302-4431
ir@equilliumbio.com
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