Equillium Provides Itolizumab COVID-19 Program Update
November 25 2020 - 8:00AM
Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology
company developing itolizumab to treat severe autoimmune and
inflammatory disorders, today announced that due to the rapidly
evolving COVID-19 treatment landscape, the company will not
initiate the EQUINOX Phase 3 clinical trial to evaluate itolizumab
in hospitalized COVID-19 patients at this time.
“Based on a thorough review of recent updates regarding the
efficacy of new potential vaccines and other treatment options, we
have made the strategic decision not to initiate our EQUINOX Phase
3 trial as previously planned. We are continuing to assess the
rapidly evolving clinical and commercial landscape related to this
pandemic and may consider other options to evaluate itolizumab in
COVID-19 patients, including government research initiatives,” said
Bruce Steel, chief executive officer of Equillium. “While this is a
difficult decision given the current high rates of infection and
significant unmet medical need, we believe it is prudent given the
recent positive advancements by our biopharma colleagues to combat
this serious pandemic. We greatly appreciate the support and effort
of our trial investigators, clinical trial sites, and our Equillium
team who played a vital role in preparing for the EQUINOX study,
especially during this challenging time.”
Mr. Steel added, “Based on recent positive itolizumab interim
clinical data in acute graft-versus-host disease (aGVHD) we plan to
prioritize our resources on expanding and accelerating this
program, as well as advancing our lupus / lupus nephritis and
uncontrolled asthma studies. We look forward to providing
additional pipeline updates at our Analyst Day on Friday, December
4.”
About Itolizumab
Itolizumab is a clinical-stage, first-in-class 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. Itolizumab is currently being evaluated in multiple
clinical trials in patients with severe diseases, including aGVHD,
lupus / lupus nephritis and uncontrolled asthma. Equillium acquired
rights to itolizumab through an exclusive partnership with Biocon
Limited. Itolizumab is marketed in India under the trade name
“ALZUMAb-L” for the treatment of chronic plaque psoriasis and has
received emergency use approval in India to treat cytokine release
syndrome in COVID-19 patients with moderate to severe acute
respiratory distress syndrome.
About Equillium
Equillium 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, aGVHD, lupus
nephritis and uncontrolled asthma.
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. 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 potential benefit of treating
patients with aGVHD, uncontrolled asthma, lupus / lupus nephritis,
or COVID-19 with itolizumab, Equillium’s business strategy,
Equillium’s plans and expected timing for developing itolizumab,
including the expected timing of initiating, completing and
announcing further results from the EQUATE, EQUIP and EQUALISE
studies, the potential benefits of itolizumab, the potential for
the any of Equillium’s ongoing or planned clinical trials to show
safety or efficacy, the impact of the COVID-19 pandemic. Risks that
contribute to the uncertain nature of the forward-looking
statements include: the risk that interim results of a clinical
trial 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 trials
and the reporting of data therefrom; the risk that studies will not
be completed as planned; uncertainties related to Equillium’s
capital requirements; Equillium’s plans and product development,
including the initiation, restarting and completion of clinical
trials; uncertainties related to the actual impacts and length of
such impacts caused by the COVID-19 pandemic; uncertainties caused
by the recent restarting of the EQUIP and EQUALISE clinical trials
after a pause; whether the results from clinical trials will
validate and support the safety and efficacy of itolizumab; changes
in the competitive landscape, and uncertainties 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 with the
United States Securities and Exchange Commission. 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
Communications+1-619-302-4431ir@equilliumbio.com
Media ContactKatherine Carlyle SmithSenior
Account AssociateCanale Communications+1-805-907-2497
katherine.smith@canalecomm.com
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