XOMA Corporation (Nasdaq:XOMA), a leader in the discovery and
development of therapeutic antibodies, announced today it has
initiated a Phase 2 proof-of-concept study to evaluate the safety
and ability to prevent hypoglycemia (dangerously low blood sugar)
of a single dose of XOMA 358 in patients with congenital
hyperinsulinism (HI). XOMA 358 is a fully human allosteric
monoclonal antibody that reduces insulin receptor activity.
HI is a genetic disorder in which the beta cells of the pancreas
secrete excessive insulin that causes hypoglycemia, which can lead
to brain damage or, in rare cases, death. HI is a rare disease,
affecting approximately 1 in 50,000 newborns. The U.S. Food and
Drug Administration (FDA) granted Orphan Drug Designation to XOMA
358 for the treatment of HI.
"New treatments that safely and effectively attenuate
insulin-induced hypoglycemia are needed for patients with
congenital hyperinsulinism, as well as other diseases that cause
hypoglycemia due to high insulin levels. There are no approved
medications, and those currently used have inconsistent efficacy
and issues with tolerability. Current disease management options
are limited to continuous ingestion or infusion of glucose or
surgical removal of part or all of the pancreas," said Paul Rubin,
M.D., Senior Vice President, Research and Development, and Chief
Medical Officer at XOMA. "We are developing XOMA 358 as a
first-in-class therapeutic for patients with this potentially fatal
disease, and we are pleased to be conducting this study at a
world-class medical center recognized for its leadership in
treating HI patients."
Proof-of-Concept Study Design
The open-label, single-administration study will evaluate XOMA
358 in congenital hyperinsulinism patients with documented
hypoglycemia after a prolonged fast. Two cohorts of patients are
planned, with the first cohort receiving a dose of XOMA 358 chosen
based on the results from XOMA's Phase 1 study in healthy subjects.
The second cohort of patients may receive a higher or lower dose
dependent on the results seen in cohort 1. Patients will serve as
their own control. The study will attempt to provoke and document
hypoglycemic events due to fasting challenges prior to treatment
with XOMA 358. Patients who experience hypoglycemia will be treated
with XOMA 358 and then rechallenged by fasting at predetermined
points in time to measure the potential impact and durability of
XOMA 358 on hypoglycemia.
The study is open for patient enrollment at the Children's
Hospital of Philadelphia (CHOP) and an additional international
site is expected to open in the near-term. 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. Controlled tests include monitored fasts, protein
challenges, and oral glucose tolerance.
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 after 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 trial may be found at www.clinicaltrials.gov.
About Congenital Hyperinsulinismi, ii,
iii, iv
Congenital Hyperinsulinism (HI) is a genetic disorder in which
the insulin cells of the pancreas (beta cells) secrete
inappropriate and excessive insulin. Ordinarily, beta cells secrete
just enough insulin to keep blood sugar in the normal range. In
people with HI, the secretion of insulin is not properly regulated,
causing excess insulin secretion and frequent episodes of low blood
sugar (hypoglycemia). In infants and young children, these episodes
are characterized by a lack of energy (lethargy), irritability or
difficulty feeding. Repeated episodes of low blood sugar increase
the risk for serious complications, such as breathing difficulties,
seizures, intellectual disability, vision loss, brain damage, coma,
and possibly death. About 60 percent of infants with HI experience
a hypoglycemic episode within the first month of life. Other
affected children develop hypoglycemia by early childhood. Current
treatments for HI are limited to medical therapy and surgical
removal of part or all of the pancreas (pancreatectomy).
About XOMA Corporation
XOMA Corporation is a leader in the discovery and development of
therapeutic antibodies. The Company's innovative product candidates
result from the Company's 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 6 endocrine assets, each of which have 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 effect
on the treatment of hyperinsulinism. The Company recently initiated
Phase 2 development activities for XOMA 358. Additionally, XOMA is
developing gevokizumab (IL-1 beta modulating antibody) in an
ongoing Phase 3 program enrolling patients with pyoderma
gangrenosum, a rare ulcerative skin condition. For more
information, visit www.xoma.com.
Forward-Looking Statements
Certain 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, 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
ghr.nlm.nih.gov/condition/congenital-hyperinsulinism. Accessed June
11, 2015.
ii
www.chop.edu/conditions-diseases/congenital-hyperinsulinism/about#.VXncFU3bKHt.
Accessed June 11, 2015.
iii
www.chop.edu/conditions-diseases/congenital-hyperinsulinism/about#.VXneYE3bKHu.
Accessed June 11, 2015.
iv www.ojrd.com/content/pdf/1750-1172-6-63.pdf. Accessed June
11, 2015.
CONTACT: Investor Contacts:
Ashleigh Barreto, XOMA
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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