- Results from two Phase 2 erosive osteoarthritis of the hand
studies do not support movement to pivotal development
- FDA End of Phase 2 meeting for pyoderma gangrenosum indication
scheduled for March 2014
- Conference call to be held today at 6:00 p.m. Eastern / 3:00
p.m. Pacific
XOMA Corporation (Nasdaq:XOMA), a leader in the discovery and
development of therapeutic antibodies, provided an update on its
gevokizumab development program. Based on results from the
Company's Phase 2 program in patients with erosive osteoarthritis
of the hand (EOA), XOMA does not intend to launch pivotal
development for the broad EOA indication. The Company will conduct
a review of the full dataset to determine if there is a segment of
the patient population that best responds to gevokizumab therapy
prior to initiating any potential additional clinical studies in
this indication. Gevokizumab appeared to be well tolerated, and the
most common adverse events were comparable between both the
gevokizumab and placebo groups. XOMA will continue to focus its
efforts on completing the EYEGUARD™ Phase 3 clinical program,
preparing to initiate its Phase 3 program in patients with pyoderma
gangrenosum (PG), and assessing gevokizumab in pilot studies of
other rare diseases that are in need of new therapeutic
options.
"We launched our proof-of-concept program for gevokizumab just
over two years ago. We developed a thoughtful plan that would allow
data derived from well-designed clinical studies using gevokizumab
to lead us to the best opportunities to follow our ongoing Phase 3
studies in non-infectious and Behçet's uveitis. While we are
disappointed in today's results, the new information we received
from these Phase 2 studies informs our next decisions. The data we
generated in our erosive osteoarthritis of the hand studies enabled
our decision not to initiate large Phase 3 studies for this
indication. In contrast, the data that we generated last fall in
pyoderma gangrenosum allowed us to select this orphan indication as
our next Phase 3 effort," stated John Varian, Chief Executive
Officer of XOMA. "The data Servier and we are generating in
six additional indications we have disclosed, as well as other
indications we haven't yet disclosed, will continue to light our
pathway forward."
XOMA conducted two separate double-blind, placebo-controlled
clinical studies in patients with EOA. The first study (Study
160) enrolled 85 patients who were diagnosed with EOA and who had a
high-sensitivity C-reactive protein (CRP) level ≥2.5 mg/L.
CRP is recognized as a biomarker for generalized
inflammation. The second study (Study 162) enrolled 92
patients who met the criteria for the first study but did not have
elevated CRP. In both studies, patients were randomized 2:1 to
receive either gevokizumab 60mg or placebo, dosed subcutaneously
once monthly. Both studies were designed to determine if
gevokizumab could improve the pain, stiffness, and physical
function associated with EOA, based upon the Australian/Canadian
Osteoarthritis Hand Index (AUSCAN™) scoring scale. AUSCAN is a
validated self-administered questionnaire specifically designed to
assess the three dimensions of pain, disability, and joint
stiffness of osteoarthritis of the hand using a series of 15
questions. Study 160 assessed the change in AUSCAN score from
baseline at Days 84 and 168 in addition to assessing improvements
of the effected joints from baseline using radiographic and MRI
images taken at Days 84 and 168. Study 162 assessed the change
in AUSCAN score from baseline at Day 84, the results in the second
study did not show the same strength as the Day 84 results from
Study 160.
The initial results from Study 160 showed separation between the
gevokizumab and placebo scores favoring gevokizumab over the 84-day
period. While the gevokizumab-treated patients continued to
show an improvement in all AUSCAN measures over their baseline
scores after 168 days of therapy, the placebo treated patients
showed a greater improvement over the final three months of the
study, eliminating the separation seen between placebo and actively
treated patients by the Day 168 time point. The Company's
primary analyses and other objective measures, such as MRIs and
radiographs, did not suggest a significant drug-related benefit
after six months.
XOMA has begun analyses of relevant patient subgroups, and these
data have shown placebo response was driven by patients with milder
disease at baseline. Comparisons of patients with more severe
pain (visual analog scale ≥ 75/100) at baseline show a consistent
trend favoring gevokizumab in all components of their AUSCAN
scores. In both proof-of-concept studies, gevokizumab
demonstrated a statistically significant effect on CRP levels over
the full study periods. It is possible these observations, as
well as further analyses, could provide a reasonable group to study
in future trials but it is too early to tell at this point.
Gevokizumab was generally well tolerated, and there were no
drug-related serious adverse events reported in these
studies. The most common adverse events were headache, pain,
arthralgia, urinary tract infections, upper respiratory tract
infections and pneumonia, and they were comparable between
gevokizumab and placebo.
"We have rapidly advanced our pyoderma gangrenosum clinical
program since we launched our pilot study in June of 2013, and our
End of Phase 2 meeting with the Food and Drug Administration will
be taking place in March. We expect we will be able to
announce our Phase 3 clinical program in this rare and serious
indication during April," commented Paul Rubin, MD, Senior Vice
President Research and Development and Chief Medical Officer of
XOMA.
Investor Conference Call and Webcast
XOMA will host a webcast today, March 4, 2014, at 6:00 p.m. ET /
3:00 p.m. PT. The webcast can be accessed via the Investors
and Media section of XOMA's website at
http://investors.xoma.com/events.cfm and will be available for
replay until close of business on May 4, 2014.
Telephone numbers for the live audiocast are 877-369-6589
(U.S./Canada) and 408-337-0122 (international).
About Gevokizumab
Gevokizumab is a potent monoclonal antibody with unique
allosteric modulating properties and 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 uveitis (including Behçet's uveitis), cardiovascular
disease, and other auto-inflammatory diseases.
Gevokizumab currently is being studied in a global Phase 3
clinical program, termed EYEGUARD™, which is being conducted by
SERVIER and XOMA. This program is designed to determine
gevokizumab's ability to treat acute non-infectious uveitis (NIU)
in EYEGUARD-A, to prevent disease flares in patients with Behçet's
uveitis in EYEGUARD-B, and to prevent disease flares in NIU
patients who are controlled with steroids and immunosuppressants in
EYEGUARD-C.
XOMA has a Proof-of-Concept (POC) program underway in which the
Company is exploring or has explored the efficacy and safety of
gevokizumab in multiple indications: pyoderma gangrenosum, pustular
psoriasis, moderate to severe inflammatory acne, erosive
osteoarthritis of the hand, active non-infectious scleritis,
autoimmune inner ear disease. Separately, SERVIER initiated a
Phase 2 study to determine gevokizumab's ability to reduce arterial
wall inflammation in patients with marked atherosclerotic plaque
inflammation and who have experienced an acute coronary syndrome in
the previous twelve months, as well as POC studies in
polymyositis/dermatomyositis, Schnitzler syndrome, and giant cell
arteritis. Information about gevokizumab clinical studies can
be found at www.clinicaltrials.gov and
www.clinicaltrialsregister.eu.
About Erosive Osteoarthritis of the Hand
Erosive osteoarthritis of the hand (EOA) is caused by the
breakdown of the body's natural balance between cartilage formation
and degradation, which leads to the narrowing of the space between
the first and second joints in the fingers. Patients with EOA
experience high degrees of pain, including throbbing, swelling, and
prolonged periods of morning stiffness. Over time, the joints
become deformed, impacting hand function and ultimately reducing
EOA patients' quality of life. Approximately two million
people in the U.S. have been diagnosed with EOA, and the disease
affects women twelve times more often than men for reasons that are
not understood by the scientific or medical community.
About Pyoderma Gangrenosum
Pyoderma gangrenosum (PG) is a rare neutrophilic dermatosis of
painful expanding necrotic skin ulcers, which has four
classifications based upon the type of skin ulcers
manifested. The U.S. Department of Health and Human Services'
National Institutes of Health's Office of Rare Disease Research
lists PG occurring in about 1 per 100,000
people. Approximately 50 to 70 percent of the PG patient
population has an underlying systemic condition, while the
remainder is idiopathic (unknown cause). The most prevalent
underlying condition is inflammatory bowel disease (IBD), most
commonly ulcerative colitis and Crohn's disease. The prognosis
for PG is directly linked to the patient's response to therapy for
the underlying disease. Patients receive a combination of
topical and systemic therapy to treat the ulcers, which may take up
to two years to heal. Despite the ongoing use of systemic
therapy, up to 46 percent of patients experience a relapse.
About XOMA
XOMA has built a portfolio of innovative therapeutic antibodies,
both in late-stage clinical development and in preclinical
research. XOMA focuses its antibody research and development
on allosteric modulation, which offers opportunities for new
classes of therapeutic antibodies to treat a wide range of human
diseases. XOMA's lead product candidate, gevokizumab (IL-1
beta modulating antibody), is in a global Phase 3 program in
non-infectious uveitis with its partner SERVIER and multiple
proof-of-concept studies in other IL-1-mediated
diseases. XOMA's scientific research also produced the XMet
program, which consists of three classes of preclinical antibodies,
including Selective Insulin Receptor Modulators (SIRMs) that could
have a significant effect on the treatment of diabetes.
More detailed information can be found at www.xoma.com.
About SERVIER
"Since the company's creation, all of our
profits are ploughed back into research." |
Jacques Servier, Founding President of the
Group. |
Founded in 1954, Servier is an independent French pharmaceutical
research company. 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. With a strong international presence in 140
countries, Servier employs more than 22,000 people
worldwide. In 2012, the company recorded revenue of 3.9
billion euros, and 92% of Servier drugs are consumed
internationally. The Servier Group contributed 57% to the 2012
French trade surplus in the pharmaceuticals sector. The
Company reinvested 25% of its revenues into R&D in 2012.
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 research and
clinical trials, anticipated timing of initiation and completion of
clinical trials and proof-of-concept trials, anticipated size of
clinical trials, sufficiency of our cash resources and anticipated
levels of cash utilization, 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
Company and Investor Contact:
Ashleigh Barreto
510-204-7482
barreto@xoma.com
Juliane Snowden
The Oratorium Group, LLC
jsnowden@oratoriumgroup.com
Media Contact:
Canale Communications
Carolyn Hawley
619-849-5375
carolyn@canalecomm.com
XOMA (NASDAQ:XOMA)
Historical Stock Chart
From Apr 2024 to May 2024
XOMA (NASDAQ:XOMA)
Historical Stock Chart
From May 2023 to May 2024