Equillium Announces Plans to Initiate Phase 3 Pivotal Study of Itolizumab in First-line Treatment of Acute Graft-Versus-Host ...
July 12 2021 - 4:01PM
Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology
company developing itolizumab to treat severe autoimmune and
inflammatory disorders, today announced the completion of an
End-of-Phase 1 meeting with the U.S. Food and Drug Administration
(FDA) for itolizumab in first-line treatment of patients with acute
graft-versus-host disease (aGVHD). The meeting confirmed a path to
advance itolizumab into a single Phase 3 pivotal study to support
the Biologics License Application (BLA) filing for itolizumab in
first-line treatment of aGVHD patients. The company plans to
initiate the Phase 3 study in Q4 2021.
“Following the positive outcome of our meeting with the FDA, we
will immediately advance to a pivotal clinical study, moving one
step closer to developing the first approved therapy to treat aGVHD
patients in the first-line setting,” said Dolca Thomas, executive
vice president of research and development and chief medical
officer of Equillium. “This extremely ill patient population is
significantly underserved by today’s standard of care – high-dose
corticosteroids. Our EQUATE Phase 1b study demonstrated rapid and
durable complete clinical responses and a swift reduction in
systemic corticosteroid use that are critical for positive
longer-term patient outcomes. Itolizumab has received FDA fast
track and orphan drug designations for the treatment of aGVHD, and
with this feedback from the FDA we are immediately transitioning to
late-stage development and look forward to collecting the data
needed to support a BLA filing.”
The meeting provided guidance from the FDA on the pivotal study
design, as well as advice on chemistry, manufacturing and controls
(CMC), nonclinical and regulatory-related topics to support
Equillium’s proposed single pivotal clinical study and BLA
submission of itolizumab for the first-line treatment of aGVHD in
combination with corticosteroids. The randomized double-blinded
pivotal study will evaluate one dosing regimen of itolizumab versus
standard of care (high-dose corticosteroids) and will include
complete response at Day 29 as the primary endpoint, with an
interim evaluation for futility and efficacy at 50% patient
enrollment. Equillium is finalizing details of the Phase 3 protocol
based on feedback and guidance from the FDA.
About Graft-Versus-Host Disease (GVHD)GVHD is a
multisystem disorder that is a common complication of allogeneic
hematopoietic stem cell transplants (allo-HSCT) caused by the
transplanted immune system recognizing and attacking the
recipient’s body. Symptoms of GVHD include rash, itching, skin
discoloration, nausea, vomiting, diarrhea, and jaundice, as well as
eye dryness and irritation.
GVHD is the leading cause of non-relapse mortality in cancer
patients receiving allo-HSCT, and its risk limits the number and
type of patients receiving HSCT. GVHD results in high morbidity and
mortality, with five-year survival of approximately 53% in patients
who respond to steroid treatment and mortality as high as 95% in
patients who do not respond to steroids. There are no approved
treatments for first-line aGVHD. Published literature (MacMillan et
al., 2015) describes background response rates to high-dose steroid
administration in severe high-risk patients as 43% overall response
and 27% complete response.
About ItolizumabItolizumab 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 EquilliumEquillium is a clinical-stage
biotechnology company leveraging deep understanding of
immunobiology to develop novel products to treat severe autoimmune
and inflammatory disorders with high unmet medical need. Equillium
is developing itolizumab for multiple severe immuno-inflammatory
diseases, including a planned pivotal study in acute
graft-versus-host-disease (aGVHD), a Phase 1b study in lupus/lupus
nephritis and a Phase 1b study in uncontrolled asthma.
For more information, visit www.equilliumbio.com.
Forward Looking StatementsStatements 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. Words such as
“expect,” “estimate,” “project,” “budget,” “forecast,”
“anticipate,” “intend,” “plan,” “may,” “will,” “could,” “should,”
“believes,” “predicts,” “potential,” “continue” and similar
expressions are intended to identify such forward-looking
statements. Because such statements are subject to risks and
uncertainties, 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
capitalization, resources and funding of Equillium, the potential
benefit of treating patients with aGVHD with itolizumab,
Equillium’s plans and expected timing for developing itolizumab
including the expected timing of initiating, completing and
announcing further results from the acute graft-versus-host disease
program, the potential for any of Equillium’s ongoing or planned
clinical studies to show safety or efficacy, statements regarding
the impact of new leadership team members, Equillium’s anticipated
timing of regulatory review and feedback, and Equillium’s plans and
expected timing for developing itolizumab and potential benefits of
itolizumab. Risks that contribute to the uncertain nature of the
forward-looking statements include: uncertainties related to the
abilities of new leadership team members to integrate and 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 itolizumab; 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” in Equillium’s Annual Report on Form 10-K for the year
ended December 31, 2020, and elsewhere in Equillium’s filings
and reports with the SEC. 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.
Investor ContactMichael Moore Vice President,
Investor Relations & Corporate
Communications619-302-4431ir@equilliumbio.com
Media ContactsAljanae ReynoldsWheelhouse Life
Science Advisorsareynolds@wheelhouselsa.com
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