Equillium Announces Abstracts Accepted for Presentation at the 2023 Annual Meetings of the American Society of Nephrology and the American College of Rheumatology
October 19 2023 - 8:00AM
Business Wire
EQUALISE Phase 1b Study in lupus nephritis
fully enrolled – topline data in early 2024
Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology
company focused on developing novel therapeutics to treat severe
autoimmune and inflammatory disorders, today announced that
abstracts were accepted for poster presentations at the annual
meetings of the American Society of Nephrology (ASN) and the
American College of Rheumatology (ACR). ASN is taking place at the
Pennsylvania Convention Center in Philadelphia, PA, November 1 – 5,
and ACR is taking place at the San Diego Convention Center in San
Diego, CA, November 10 - 15.
The abstracts highlight data from 17 Type B subjects in the
Phase 1B EQUALISE study in highly proteinuric lupus nephritis
patients (mean 24-hour urine protein creatinine ratio (UPCR) > 4
g/day). The data demonstrate that subjects had high complete and
partial response rates with rapid and deep reduction in UPCR when
itolizumab was added to mycophenolate mofetil and corticosteroids.
This is in the setting of tapering the corticosteroids, stable
kidney function (eGFR) and increasing serum albumin while on study.
Itolizumab was well tolerated when treated every 2 weeks for 24
weeks; with only 2 subjects reporting serious adverse events.
American Society of Nephrology American College of
Rheumatology Title: EQUALISE Type B: Clinical results of
itolizumab, a novel anti-CD6 therapy, in subjects with lupus
nephritis Author: Dr. Kenneth Kalunian, Professor, Medicine, UCSD
School of Medicine Poster Number: SA-PO875 Assigned Session:
Glomerular Diseases: Therapeutics Date and Time: November 4, 10:00
am ET – 12:00 pm ET
American College of Rheumatology Title: Clinical Safety
and Efficacy Results from EQUALISE Type B: A Phase 1b Open-label
Clinical Study of Itolizumab, a Novel anti-CD6 Therapy, in Subjects
with Active Proliferative Lupus Nephritis Author: Dr. Kenneth
Kalunian, Professor, Medicine, UCSD School of Medicine Abstract
Number: 1496 Assigned Session: SLE – Treatment Poster II Date and
Time: November 13, 9:00 am ET – 11:00 am PT
The abstracts are available on the ASN website and ACR website.
Poster presentations will be 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,
currently enrolling, 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 up to
20 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. 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. 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. 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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