Servier Initiates Phase 2 Study of Gevokizumab in Patients With Diabetic Nephropathy
April 01 2015 - 8:01AM
XOMA Corporation (Nasdaq:XOMA), a leader in the discovery and
development of therapeutic antibodies, announced today gevokizumab
will be tested in a Phase 2 study in patients with Type 2 diabetes
and diabetic kidney disease, clinically referred to as diabetic
nephropathy. The international, multicenter, randomized,
double-blind, parallel-group, placebo-controlled study is expected
to enroll 370 patients who will be randomized to receive
gevokizumab or placebo for 52 weeks. The primary objective of this
study is to detect the existence of an overall dose-response
relationship of subcutaneously dosed gevokizumab on the measured
glomerular filtration rate (mGFR), an accurate measure of kidney
function, at Week 52. The study also will determine gevokizumab's
effect on a number of biological biomarkers assessing kidney
function. Servier will fully sponsor the study's execution and
cost.
"We are very pleased Servier has elected to pursue gevokizumab
in patients with diabetic nephropathy," stated John Varian, Chief
Executive Officer of XOMA. "This disease, which is a common
long-term complication associated with diabetes, has long been
identified as a disease that needs new therapeutic options.
Approximately one-third of all diabetics will develop some form of
nephropathy, and many will progress to end-stage renal
disease. Treating patients early hopefully will reduce the
number who progress to the most serious stages of the disease."
"Servier is highly committed to developing innovative treatments
for diseases with clear unmet medical needs, such as the diabetic
nephropathy. The potential anti-inflammatory properties of
gevokizumab ultimately may prove its clinical value in this
disease. Servier is delighted by this new and important step
in the clinical development of the drug," said Isabelle
Tupinon-Mathieu, M.D., R&D Vice President, Head of Metabolism
and Cardiovascular Innovation Centers at Servier.
Inflammatory kidney disease is a cause of morbidity and
mortality in diabetic patients. There is an increasing amount
of evidence that interleukin-1 beta (IL-1 beta), is one of the
cytokines involved in the pathogenesis of diabetic
nephropathy. A mouse model study of renal inflammation showed
gevokizumab significantly decreased proteinuria, a commonly seen
abnormality in diabetic nephropathy, and several other renal
function biomarkers compared to placebo. Gevokizumab also
reduced inflammatory cytokine responses in blood and kidney cortex
extracts, as well as reduced development of fibrosis, the scarring
of tissues that is central to the reduction of kidney function.
About Gevokizumab
Gevokizumab is a potent monoclonal antibody with unique
allosteric modulating properties and has the potential to treat
patients with a wide variety of inflammatory and other
diseases. Gevokizumab binds strongly to interleukin-1 beta
(IL-1 beta), a pro-inflammatory cytokine, and modulates the
cellular signaling events that produce inflammation. IL-1 beta
has been shown to be involved in diverse array of disease states,
including non-infectious and Behçet's disease uveitis,
cardiometabolic diseases and other auto-inflammatory diseases.
Gevokizumab currently is being studied in multiple indications,
including global Phase 3 clinical programs in Behçet's disease
uveitis, non-infectious uveitis and pyoderma
gangrenosum. Information about all gevokizumab clinical
studies can be found at www.clinicaltrials.gov and
www.clinicaltrialsregister.eu.
About XOMA Corporation
XOMA's innovative product candidates are the result of the
Company's expertise in developing ground-breaking monoclonal
antibodies, including allosteric modulating antibodies, which have
created new opportunities to potentially treat a wide range of
human diseases. XOMA is developing its lead product gevokizumab
(IL-1 beta modulating antibody) with Servier through a global Phase
3 program for Behçet's disease uveitis and non-infectious
uveitis. XOMA also has an ongoing Phase 3 study of gevokizumab
in pyoderma gangrenosum. Additionally, XOMA's scientific
research has produced the XMet program, which consists of three
classes Selective Insulin Receptor Modulators (SIRMs)
antibodies. XOMA 358, the lead antibody in the XMetD program
that recently completed Phase 1 testing, is an allosteric
modulating monoclonal antibody that reduces both the binding of
insulin to its receptor and down-regulates insulin signaling and
could have a major effect on the treatment of abnormal metabolic
states.
More detailed information can be found at www.xoma.com.
About Servier
Servier is an independent French pharmaceutical research company
with a strong international presence in 146 countries that employs
more than 21,400 people worldwide. Its development is based on the
continuous pursuit of innovation in the therapeutic areas of
cardiovascular, metabolic, neurologic, psychiatric, bone and joint
diseases, as well as cancer. In 2014, the company recorded revenue
of 4 billion euros, 92 percent of which was generated from sales
outside of France, and reinvested 28 percent of the revenue in
Research and Development activities.
More information is available at: www.servier.com.
Forward-Looking Statements
Certain statements contained in this press release including,
but not limited to, statements related to anticipated timing of
initiation and completion of clinical trials, anticipated size and
rate of enrollment of clinical trials, regulatory approval of
unapproved product candidates, the anticipated success of any
product launch, or statements that otherwise relate to future
periods are forward-looking statements within the meaning of
Section 27A of the Securities Act of 1933 and Section 21E of the
Securities Exchange Act of 1934. These statements are based on
assumptions that may not prove accurate, and actual results could
differ materially from those anticipated due to certain risks
inherent in the biotechnology industry and for companies engaged in
the development of new products in a regulated
market. Potential risks to XOMA meeting these expectations are
described in more detail in XOMA's most recent filing on Form 10-K
and in other SEC filings. Consider such risks carefully when
considering XOMA's prospects. Any forward-looking statement in
this press release represents XOMA's views only as of the date of
this press release and should not be relied upon as representing
its views as of any subsequent date. XOMA disclaims any obligation
to update any forward-looking statement, except as required by
applicable law.
CONTACT: XOMA Corporation
Ashleigh Barreto
510-204-7482
barreto@xoma.com
Juliane Snowden
The Oratorium Group, LLC
jsnowden@oratoriumgroup.com
Servier Communications Department
+33 1-5572-6037
presse@servier.fr
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