XOMA Presents Positive Phase 1 XOMA 358 Data at the ENDO Meeting
March 07 2015 - 4:05PM
- Results show XOMA 358 reduces insulin receptor signaling and
increased glucose production after exogenous insulin injection
- XOMA 358 shows potential for treatment of hyperinsulinemic
hypoglycemia conditions
XOMA Corporation (Nasdaq:XOMA), a leader in the discovery and
development of therapeutic antibodies, announced the presentation
of data from XOMA 358, the lead antibody in the Company's XMet D
program, today, at the Endocrine Society's Annual Meeting – ENDO
2015. Paul Rubin, M.D., Senior Vice President, Research and
Development, and Chief Medical Officer at XOMA, presented the
Company's data, titled "XOMA 358, a Novel Treatment for
Hyperinsulinemic Hypoglycemia: Safety and Clinical Pharmacology
from the First in Human Trial".
"The XOMA 358 Phase 1 data is the first to show that a
monoclonal antibody can down-regulate the insulin receptor and its
downstream signaling. Insulin is the primary hormone in blood
glucose regulation, and there are several rare diseases where the
body produces inappropriately high levels of insulin, causing
dangerously low blood sugars. This condition, which can lead to
brain damage or, in rare cases, death, often requires extensive
therapy including continuous ingestion of glucose or even
pancreatectomy," stated Dr. Rubin. "Our results suggest XOMA 358 is
a first-in-class molecule active against the insulin receptor and
shows potential for treatment of patients who experience this
endogenous over-production of insulin."
The Phase 1 first-in-human study enrolled 19 healthy volunteer
subjects; 14 received XOMA 358 and 5 received placebo. Individual
cohorts were administered XOMA 358 doses of 0.1, 0.3, 1, and 3
mg/kg or placebo, with dose escalation based on review of safety
and pharmacokinetic data from each cohort. Changes in insulin and
glucose were monitored through the use of Mixed meal tests (MMTs)
and insulin tolerance tests (ITT). Dose-related increases in
post-prandial (after eating a meal) glucose levels, consistent with
down-regulation of insulin signaling, were observed through Day 6
following drug infusion, with the Day 3 glucose AUC nearly 80%
greater than placebo at the 1 mg/kg dose level. Fasting HOMA-IR
values, a measure of reduced insulin signaling, were likewise
elevated in a dose-dependent manner and, at peak time points, were
several fold over baseline.
Subjects who were given a single administration of XOMA 358 at 3
mg/kg were infused with insulin before and 2, 3 and 5 days after
dosing. Prior to administration of the drug, as expected, the
infusion caused a significant lowering of blood sugar. This
lowering of blood sugar was significantly blunted at all subsequent
time points tested.
These preliminary data provide a strong rationale for continued
study of XOMA 358 in adults and children with hypoglycemia due to
overproduction of insulin. XOMA 358 appeared to be well-tolerated;
there were no serious adverse events.
About XOMA 358
Insulin is the major hormone for lowering blood glucose levels.
Abnormal increases in insulin secretion can lead to profound
hypoglycemia (low blood sugar), a state that can result in
significant morbidities including cerebral damage and epilepsy. In
some instances, profound hypoglycemia can be fatal. XOMA 358 is a
fully human allosteric modulating monoclonal antibody that binds to
insulin receptors and attenuates insulin action. XOMA 358 is being
investigated as a novel treatment for non-drug-induced, endogenous
hyperinsulinemic hypoglycemia (low blood glucose caused by
excessive insulin production) and other related disorders. A
therapy that safely and effectively mitigates insulin-induced
hypoglycemia has the potential to address a significant unmet
therapeutic need for certain rare medical conditions associated
with hyperinsulinism.
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, non-infectious uveitis and
pyoderma gangrenosum. XOMA's scientific research also produced the
XMet program, which consists of three classes Selective Insulin
Receptor Modulators (SIRMs) antibodies. XOMA 358, the lead antibody
in the XMetD program, 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.
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, 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: Company and Investor Contacts:
Ashleigh Barreto
510-204-7482
barreto@xoma.com
Juliane Snowden
The Oratorium Group, LLC
jsnowden@oratoriumgroup.com
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