XOMA Corporation (Nasdaq:XOMA), a leader in the discovery and
development of therapeutic antibodies, announced today that it has
established proof-of-concept for its product candidate 358 in
congenital hyperinsulinism (CHI) and hypoglycemia post-bariatric
surgery (PBS). The Company will host a webcast and conference call
today, January 31, 2017, at 2:00 p.m. PST (5:00 p.m. EST) to share
data from these studies. The CHI acute studies have met their
objectives of establishing initial safety and 358 proof-of-concept
in CHI patients aged 12 and up across several dosing levels. The
Company is nearing the launch of a multi-dose study in children
with CHI aged 2 and up that will be conducted in the United
Kingdom. The PBS study has completed dosing in the single-dose
cohorts and has also met its objectives; a multi-dose study has
been initiated.
“With the large unmet clinical need in patients with CHI and
PBS, 358 provides a first-in-class antibody with the potential to
help pediatric and adult patients properly regulate their blood
glucose concentrations and prevent hypoglycemic episodes,” said
Eric P. Brass, M.D., Ph.D., Professor Emeritus of Medicine, David
Geffen School of Medicine, University of California, Los Angeles.
“These data clearly demonstrate that a single-dose of 358 results
in predictable and reproducible pharmacokinetics and meaningful
improvements in glucose concentrations. The Company can now assess,
in follow-on studies, the consistency and magnitude of 358’s effect
through multi-dose protocols to yield sustained steady-state drug
exposure in the target populations.”
CHI is a rare disease that results in the sustained over
production of insulin and usually presents early in life. Parents
and children living with CHI are required to be hyper vigilant to
ensure the child’s blood glucose level does not fall below a
critical threshold as they face the risk of seizures and long-term
cognitive impairment. 358 has been designated an orphan drug
intended for the treatment of CHI in the United States (U.S.) and
European Union. Post-bariatric surgery patients are also at risk
for debilitating episodes of hypoglycemia. Of the nearly 67,000
patients each year that undergo the Roux-en-Y method of bariatric
surgery, approximately five percent will develop severe
hypoglycemia. Severe hypoglycemia can have a significant impact on
a patient’s health and ability to participate in the normal
activities of daily life.
“There are thousands of children and adults worldwide who are
living with hyperinsulinemic hypoglycemia,” said Jim R. Neal, Chief
Executive Officer of XOMA. "When we consider the totality of
preclinical and clinical evidence, we are confident
proof-of-concept has been established for 358. It inhibits insulin
signaling by binding to the insulin receptor in an allosteric
manner and the antibody appears to be safe and well tolerated. It
is clear that 358 is ready to move into multi-dose studies.”
Conference Call DetailsThe presentation slides
and 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. Telephone numbers for the live audiocast are
1-408-337-0122 and 1-877-369-6589 (Toll-Free) with the passcode
61229012.
About 358Insulin 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.
358 is a fully human negative allosteric modulating insulin
receptor antibody derived from the XMet platform. It is being
investigated as a novel treatment for non-drug-induced, endogenous
hyperinsulinemic hypoglycemia (low blood glucose caused by
excessive insulin production), as well as hypoglycemia after
bariatric surgery. XOMA is conducting Phase 2 development
activities for 358 in patients with congenital hyperinsulinism
(CHI) and in patients with hypoglycemia post-bariatric surgery
(PBS). 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
358 clinical trials may be found at www.clinicaltrials.gov and
www.clinicaltrialsregister.eu.
Open-label, Phase 2 studies evaluated 358 in 14 patients with
congenital hyperinsulinism (CHI) and 13 patients with hypoglycemia
post-bariatric surgery (PBS). The studies were performed with
expert disease centers in Philadelphia, Magdeburg, Germany, and
London for CHI, and top U.S. centers in Denver, Baltimore, Boston,
and Rochester, Minnesota for PBS.
The Phase 2 studies were monitored for safety, and serial blood
samples were collected for pharmacokinetic and pharmacodynamic
assessments. Various markers of drug activity were assessed,
including changes in glucose, ketones, insulin, C-peptide and free
fatty acid levels. Controlled tests included monitored fasts,
protein challenges, and oral glucose tolerance.
About Congenital
Hyperinsulinismi,ii,iiiCongenital Hyperinsulinism (CHI) is
a genetic disorder in which the insulin-secreting 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 CHI, 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 CHI experience a
hypoglycemic episode within the first month of life. Other affected
children develop hypoglycemia by early childhood. Current
treatments for CHI are limited to medical therapy and surgical
removal of part or all of the pancreas (pancreatectomy).
About Hypoglycemia Post-Bariatric SurgeryivAs
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-bariatric surgery 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 possible 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
attempted reversal of the gastric bypass.
About XOMA CorporationXOMA Corporation is a
leader in the 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 endocrine assets, each of
which has the opportunity to address multiple indications. The
Company's lead product candidate, 358, is an allosteric monoclonal
antibody that reduces insulin receptor activity, which could have a
major impact on the treatment of hyperinsulinism. For more
information, visit www.xoma.com.
Forward-Looking StatementsCertain statements
contained in this press release 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, including
statements regarding: the future progress of the 358 clinical
program, the medical need and market demand for 358, anticipated
future study sites and enrollments, the initiation of international
multi-dose studies, the overall promise of 358, and statements that
otherwise relate to future periods. 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 Congenital hyperinsulinism. National Institutes of Health
website. ghr.nlm.nih.gov/condition/congenital-hyperinsulinism.
January 24, 2017. Accessed January 31, 2017.
ii Congenital Hyperinsulinism. Children’s Hospital of
Philadelphia website.
www.chop.edu/conditions-diseases/congenital-hyperinsulinism/about#.VXncFU3bKHt.
Accessed January 31, 2017.
iii Arnoux et al.: Congenital hyperinsulinism: current
trends in diagnosis and therapy. Orphanet Journal of Rare Diseases
2011. 6:63.
iv Singh et al.: Hypoglycemia After Gastric Bypass Surgery.
Diabetes Spectrum 2012 Nov; 25(4): 217-221.
Investor contact:
Luke Heagle
Pure Communications
+1 910-726-1372
lheagle@purecommunications.com
Media contact:
Colin Sanford
Pure Communications
+1 415-946-1094
csanford@purecommunications.com
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