XOMA Initiates XOMA 358 Proof-of-Concept Study in Patients with Hypoglycemia Post Gastric Bypass Surgery
April 28 2016 - 10:46AM
XOMA Corporation (Nasdaq:XOMA), a leader in the discovery and
development of therapeutic antibodies, announced today it has
initiated its proof-of-concept study to evaluate the safety and
clinical pharmacology of a single dose of XOMA 358 in patients who
experience dangerously low blood glucose levels (hypoglycemia)
after undergoing gastric bypass surgery. XOMA 358 is a fully human
allosteric monoclonal antibody that reduces both the binding of
insulin to its receptor and downstream insulin signaling.
“Significant numbers of morbidly obese patients
have turned to gastric bypass surgery as a critical healthcare
intervention,” said Paul Rubin, M.D., Senior Vice President,
Research and Development, and Chief Medical Officer at XOMA.
“Unfortunately, some of these bypass surgery patients can develop a
condition where they experience severe hypoglycemia after eating a
meal. In some cases, this severe hypoglycemia cannot be managed by
diet modification or resolved by existing pharmacologic agents,
requiring patients to be treated with either a reversal of the
bypass procedure or even a partial pancreatectomy. This clinical
study will determine if XOMA 358 could be developed further as a
first-in-class medical alternative for the treatment of severe
hyperinsulinemic hypoglycemia in post gastric bypass patients.”
Proof-of-Concept Study Design The
open-label, single-dose, multi-center study, in which patients
serve as their own control, is designed to evaluate ascending dose
levels of XOMA 358 in patients with documented hypoglycemia after
gastric bypass surgery. This is a cohort study, with the first
cohort receiving a dose of XOMA 358 chosen based on the safety and
pharmacodynamics results from XOMA’s Phase 1 study in healthy
subjects. Subsequent cohorts may receive a higher or lower dose
dependent on the results seen in the first cohort. The study will
document consistent hypoglycemic events prior to treatment with
XOMA 358 and the ability of XOMA 358 to prevent these events after
dosing.
Safety will be monitored throughout the study. In
addition, serial blood samples will be collected for
pharmacokinetic and pharmacodynamic assessments. Various markers of
drug activity will be assessed, including changes in glucose,
ketones, insulin, C-peptide and free fatty acid levels. Additional
measurements of biological effect will include protein challenges
and continuous glucose monitoring.
About XOMA 358 Insulin is
the major physiologic hormone for controlling 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 brain damage, seizures and
epilepsy. XOMA, leveraging its scientific expertise in allosteric
monoclonal antibodies, developed the XMet platform, consisting of
separate classes of selective insulin receptor modulators (SIRMs)
that could have a major effect on treating patients with abnormal
metabolic states. XOMA 358 binds selectively to insulin receptors
and attenuates insulin action.
XOMA presented positive Phase 1 data on XOMA 358 at
ENDO 2015, the Endocrine Society's annual meeting, in March 2015.
Results of the study, in which 14 healthy volunteers received XOMA
358 and 5 received placebo, showed XOMA 358 reduced insulin
sensitivity and decreased glucose lowering after exogenous insulin
injection. In the study, XOMA 358 appeared to be well tolerated,
with no serious adverse events observed.
XOMA 358 is being investigated as a novel treatment
for non-drug-induced, endogenous hyperinsulinemic hypoglycemia, as
well as hypoglycemia post-bariatric surgery 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. More information
on the XOMA 358 clinical trials may be found at
www.clinicaltrials.gov.
About Hypoglycemia Post Gastric Bypass
Surgery i,ii,iii,ivAs the number of gastric bypass
surgeries to treat severe obesity has increased, so too has the
awareness that this population may experience postprandial
hypoglycemia (low blood glucose following a meal) with symptoms
developing months or years following the gastric bypass
surgery. Postprandial hypoglycemia occurs with a range of
severity in post-gastric bypass patients. The mild end of the
spectrum may be managed largely through diet modification.
The most severe forms are more prevalent in patients who underwent
a Roux-en-Y procedure, and result in severe refractory postprandial
hyperinsulinemic hypoglycemia with neuroglycopenic symptoms
(altered mental status, loss of consciousness, seizures) that
cannot be managed through diet modification. If currently
available pharmacologic agents do not resolve the condition, these
patients are treated with either a partial pancreatectomy or
reversal of the gastric bypass.
About XOMA CorporationXOMA
Corporation is a leader in the discovery and development of
therapeutic antibodies. The Company's innovative product candidates
result from its expertise in developing ground-breaking monoclonal
antibodies, including allosteric antibodies, which have created new
opportunities to potentially treat a wide range of human diseases.
XOMA's scientific research has produced a portfolio of five
endocrine assets, each of which has the opportunity to address
multiple indications. The Company's lead product candidate, XOMA
358, is an allosteric monoclonal antibody that reduces insulin
receptor activity, which could have a major impact on
hyperinsulinism. The Company recently initiated Phase 2 development
activities for XOMA 358 in patients with congenital hyperinsulinism
and in patients who experience hypoglycemia following gastric
bypass surgery. For more information, visit www.xoma.com.
Forward-Looking StatementsCertain
statements contained in this press release including, but not
limited to, statements related to anticipated timing of clinical
trials, anticipated timing of the release of clinical data,
regulatory approval of unapproved product candidates, the
anticipated process of clinical data analysis, the anticipated
success of any clinical trial, cash usage, 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.
i Foster-Schubert KE. Hypoglycemia
complicating bariatric surgery: incidence and mechanisms. Curr Opin
Endocrinol Diabetes Obes 2011;18(2):129-33.ii Patti ME
and Goldfine AB. Hypoglycaemia following gastric bypass
surgery--diabetes remission in the extreme? Diabetologia
2010;53(11):2276-9.iii Service GJ, Thompson GB, Service FJ,
Andrews JC, Collazo-Clavell ML and Lloyd RV. Hyperinsulinemic
hypoglycemia with nesidioblastosis after gastric-bypass surgery. N
Engl J Med 2005;353(3):249-54.iv Vella A and Service FJ.
Incretin hypersecretion in post-gastric bypass
hypoglycemia--primary problem or red herring? J Clin Endocrinol
Metab 2007;92(12):4563-5.
Company and Investor Contact:
Ashleigh Barreto
510-204-7482
barreto@xoma.com
Juliane Snowden
The Oratorium Group, LLC
jsnowden@oratoriumgroup.com
Media Contact:
Ryan Flinn
W2O Group
415-946-1059
rflinn@w2ogroup.com
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