Itolizumab demonstrates clinically meaningful
response in highly proteinuric subjects:
5 of 6 (83%) subjects achieved complete or
partial response and 4 of 6 (67%) subjects achieved > 80%
reduction in urine protein creatinine ratio (UPCR) by week 28
8 of 12 (67%) subjects achieved > 50%
reduction in UPCR (6 subjects still dosing)
Itolizumab continues to demonstrate favorable
safety and tolerability through six months of treatment
Management will host a conference call and
webcast today at 8:00 am ET
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 interim results from the Type B portion of the
EQUALISE study evaluating itolizumab, a first-in-class anti-CD6
monoclonal antibody selectively targeting the CD6-ALCAM pathway, in
patients with lupus nephritis (LN).
“Despite recently approved therapies, 60% of lupus nephritis
patients are failing to achieve a complete response at 12 months,
highlighting the need for new medicines with differentiated
mechanisms,” said Bruce Steel, chief executive officer at
Equillium. “We are very encouraged by the interim data from the LN
portion of the EQUALISE study as we observed compelling responses
in a patient population with significantly greater baseline
proteinuria than recent studies, with a mean baseline UPCR of 5.8
grams. At end of study, 83% of patients achieved a complete or
partial clinical response, with 67% reaching a greater than 80%
reduction in UPCR. The interim data adds to our conviction in the
clinical activity of itolizumab and the potential to be an
impactful therapy for patients with lupus nephritis. We look
forward to continuing to enroll patients in the Type B portion of
the EQUALISE study and anticipate sharing topline data in mid-2023.
In parallel, we are engaged with key opinion leaders to prepare for
later stage development that we expect can support potential
product registration.”
“I’m impressed with these promising early and deep reductions in
proteinuria, especially given the high nephrotic baseline levels,”
said Dr. Kenneth Kalunian, professor of clinical medicine at the
University of California San Diego School of Medicine and the lead
principal investigator on the EQUALISE trial. “What is particularly
striking are the higher overall response rates observed early in
the treatment course that are not typically achieved with standard
of care alone and that look competitive with data emerging from the
recently approved drugs. As a clinician, an ideal therapy would
safely and rapidly reduce the levels of proteinuria in a greater
number of patients as this has been shown to be associated with
improved long-term outcomes. These interim results from the
EQUALISE study are encouraging and provide the type of signal we’re
looking for to advance a drug to larger controlled trials.”
The Type B portion of the EQUALISE study in patients with active
proliferative LN is evaluating the safety, tolerability and
clinical activity of subcutaneous delivery of itolizumab. Patients
must present with greater than 1 gram of proteinuria and positive
biopsy 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.
For this interim analysis, 13 subjects have been enrolled and
dosed, with 11 subjects reaching at least 12 weeks of treatment and
6 subjects reaching 28 weeks 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 the interim analysis of the Type B portion
of the EQUALISE study in lupus nephritis:
- Subjects were highly proteinuric: baseline mean UPCR of 5.8
g/g
- Clinically meaningful responses were observed:
- By week 28 (or EOS):
- 3 of 6 (50%) subjects achieved CR (UPCR < 0.7 g/g)
- 2 of 6 (33%) subjects achieved PR (UPCR > 50% reduction)
- 4 of 6 (67%) subjects achieved greater than 80% reduction in
UPCR
- In all subjects receiving more than one dose:
- 8 of 12 (67%) subjects achieved greater than 50% reduction in
UPCR
- Average reduction of 60% in UPCR (over 3g of proteinuria)
- Subjects titrated steroid dose to < 7.5 mg/day consistent with EULAR/ERA-EDTA
recommendations
- Itolizumab was generally safe and well tolerated with no drug
related serious adverse events or treatment discontinuations
Data reported from the Type B portion of the EQUALISE study are
preliminary and subject to change as more patient data become
available.
Top-line data from the Type B portion of the EQUALISE study in
patients with lupus nephritis is expected to be announced
mid-2023.
Webcast and Conference Call
Management will host a conference call accompanied by a slide
presentation to discuss the interim data from the Type B portion of
the EQUALISE study in patients with lupus nephritis, for analysts
and institutional investors, at 8:00 am ET today, September 27,
2022. To access the call, please dial (888) 350-3846 or (646)
960-0251 and, if needed, provide confirmation number 8770084. A
live webcast of the call will also be available on the company’s
Investor Relations page at
https://www.equilliumbio.com/investors/events-and-presentations/default.aspx.
The webcast will be archived for 180 days.
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 pathway.
This pathway plays a central role in modulating the activity and
trafficking of T cells that drive a number of immuno-inflammatory
diseases. Equillium acquired rights to itolizumab through an
exclusive partnership with Biocon Limited.
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, a first-in-class
tri-specific cytokine inhibitor that selectively targets IL-2,
IL-9, and IL-15, is Phase 2 ready and expected to begin enrolling
patients in an alopecia areata study in the fourth quarter of 2022.
EQ102, a bi-specific cytokine inhibitor that selectively targets
IL-15 and IL-21, is ready for clinical development and expected to
begin enrolling patients in a Phase 1 study anticipated to include
normal healthy volunteers and celiac disease patients, in the
fourth quarter of 2022.
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
benefit of treating patients with aGVHD or lupus/lupus nephritis
with itolizumab, Equillium’s plans and expected timing for
developing itolizumab including the expected timing of initiating,
completing and announcing further results from the EQUALISE study,
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, 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.
Where You Can Find Additional Information
This communication does not constitute an offer to sell or the
solicitation of an offer to buy any securities or a solicitation of
any vote or approval with respect to the proposed merger pursuant
to which Equillium will acquire Metacrine, Inc. (Metacrine) or
otherwise. No offer of securities shall be made except by means of
a prospectus meeting the requirements of Section 10 of the
Securities Act of 1933, as amended. In connection with Equillium’s
pending acquisition of Metacrine, we will file a registration
statement on Form S-4 containing a joint proxy statement/prospectus
of Equillium and Metacrine and other documents concerning the
proposed Merger with the Securities and Exchange Commission (the
“SEC”). WE URGE INVESTORS TO READ THE JOINT PROXY
STATEMENT/PROSPECTUS AND THESE OTHER MATERIALS CAREFULLY WHEN THEY
BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION
ABOUT US, METACRINE AND THE PROPOSED MERGER. Investors may
obtain free copies of the joint proxy statement/prospectus (when
available) and other documents filed by us and Metacrine with the
SEC at the SEC’s website at www.sec.gov. Free copies of the joint
proxy statement/prospectus (when available) and our other SEC
filings are also available on our website at
http://www.equilliumbio.com/. Equillium, Metacrine and their
respective directors, executive officers, certain members of
management and certain employees may be deemed, under SEC rules, to
be participants in the solicitation of proxies with respect to the
proposed merger. Information regarding our officers and directors
is included in our Definitive Proxy Statement on Schedule 14A filed
with the SEC on April 13, 2022 with respect to its 2022 Annual
Meeting of Stockholders. Information regarding Metacrine’s officers
and directors is included in Metacrine’s Definitive Proxy Statement
on Schedule 14A filed with the SEC on April 7, 2022 with respect to
its 2022 Annual Meeting of Stockholders. This document is available
free of charge at the SEC’s website at www.sec.gov or by going to
Metacrine’s Investors page on its corporate website at
www.metacrine.com. This document is available free of charge at the
SEC’s website at www.sec.gov or by going to our Investors page on
its corporate website at www.equilliumbio.com. Additional
information regarding the persons who may, under the rules of the
SEC, be deemed participants in the solicitation of proxies in
connection with the proposed Merger, and a description of their
direct and indirect interests in the proposed Merger, which may
differ from the interests of our or Metacrine’s stockholders
generally, will be set forth in the joint proxy
statement/prospectus when it is filed with the SEC.
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version on businesswire.com: https://www.businesswire.com/news/home/20220927005571/en/
Investor Contact Michael Moore Vice President, Investor
Relations & Corporate Communications 619-302-4431
ir@equilliumbio.com
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