XOMA Corporation (Nasdaq:XOMA), a leader in the discovery and
development of therapeutic antibodies, provided an update on its
ongoing XOMA 358 Phase 2 studies in patients with severe
hypoglycemia due to congenital hyperinsulinism (CHI) and
post-bariatric surgery (PBS), two rare conditions resulting from
abnormal insulin function. The following is a summary of its
clinical progress related to XOMA 358 as reported in a webcast and
conference call held earlier today.
“The initial data from the XOMA 358 Phase 2
clinical studies confirms that our first-in-class allosteric
antibody is exhibiting an inhibition on insulin signaling, the
desired mechanism-of-action. This means that for patients who
are not able to properly regulate their high insulin levels and
experience severe bouts of hypoglycemia, such as those diagnosed
with congenital hyperinsulinism and certain post-bariatric surgery
patients, XOMA 358 could provide benefit in preventing hypoglycemic
episodes,” stated John Varian, Chief Executive Officer of
XOMA. “When we consider the totality of preclinical and
clinical evidence, which demonstrates that XOMA 358 down-regulates
insulin signaling by binding to the insulin receptor in an
allosteric manner, we believe XOMA 358 is ready for advancement
into Phase 2b multi-dose studies.
“I want to thank these patients for their
willingness to participate in these studies,” Mr. Varian
concluded.
XOMA 358 Initial Combined Phase 2 Clinical
DataPatients act as their own control. To confirm their
baseline status and participate in the ongoing Phase 2 studies,
each patient must have two documented hypoglycemic events, captured
by continuous glucose monitoring (CGM) or by supervised provocation
by fast, protein challenge or meal test.
The ongoing CHI study is designed to evaluate the
safety, pharmacokinetic, pharmacodynamics and biological activity
of escalating doses of XOMA 358. Preliminary data from seven
patients showed reduced duration and number of hypoglycemic
episodes with increasing dose.
In the Phase 2 PBS study, XOMA 358 showed some
effect on glucose and insulin tolerance in the face of a meal
challenge at the initial dose of 3 mg/kg in two patients.
“We believe the most relevant efficacy measures are
the duration of hypoglycemia and the number of hypoglycemic
episodes. Although the number of patients dosed with XOMA 358
is small, both time spent in a hypoglycemic state, and number of
hypoglycemic episodes decreased in a dose-dependent manner.
We will continue to further confirm this type of drug effect
in additional patients,” commented Paul Rubin, MD, Senior Vice
President Research and Development and Chief Medical Officer of
XOMA. “The data from our ongoing Phase 2 study is helping us
define the parameters that will give us the best opportunity for
demonstrating efficacy in future studies, such as the use of
continuous glucose monitoring to track glycemic profile on a
continuous basis over days and weeks.”
The update presented by the Company represents data
from twenty-two healthy volunteers, seven CHI patients and two PBS
patients receiving XOMA 358. XOMA 358 appears to be safe and
well tolerated. Reported Treatment-Emergent Adverse Events
were mostly mild and primarily related to insulin administration
from the Insulin Tolerant Test in the Phase 1 trial. No
Serious Adverse Events have been reported.
The Company anticipates enrolling a total of 12 to
15 CHI patients and up to 20 PBS patients with the majority tested
at an active dose of XOMA 358.
A replay of the webcast, along with the slide
presentation, 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 December 15,
2016.
About XOMA Phase 2 Proof-of-Concept
Studies The open-label, single-administration studies
evaluate XOMA 358 in patients with congenital hyperinsulinism (CHI)
and patients with hypoglycemia post-bariatric surgery (PBS).
The CHI study is open for patient enrollment at the Children's
Hospital of Philadelphia (CHOP), and clinical sites located in
London, England and in Magdeburg, Germany. The PBS study is open
for enrollment at Johns Hopkins University in Baltimore, the Joslin
Clinic in Boston and the Mayo Clinic in Rochester, MN.
Additional sites are expected to open in the coming months.
In addition to monitoring safety throughout the
studies, serial blood samples are being collected for
pharmacokinetic and pharmacodynamic assessments. Various
markers of drug activity are being 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 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.
XOMA 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 and other related disorders.
XOMA is conducting Phase 2 development activities for XOMA 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 XOMA 358 clinical trial may be found at
www.clinicaltrials.gov and www.clinicaltrialsregister.eu.
About Congenital Hyperinsulinismi, ii, iii,
ivCongenital Hyperinsulinism (CHI) 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 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 Gastric Bypass
Surgery As 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 the treatment
of hyperinsulinism. The Company initiated Phase 2 development
activities for XOMA 358 in patients with congenital
hyperinsulinism, and in patients with hypoglycemia after bariatric
surgery. 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: our belief that XOMA 358 is ready
to advance into Phase 2b multi-dose studies, the future progress of
the XOMA 358 clinical program, future product development plans,
the medical need and market demand for XOMA 358, the design of
future clinically relevant studies, anticipated future study sites
and enrollments, possible increases in magnitude of response as new
study participants are added and dosages increased, dose-dependent
benefits on duration and frequency of hypoglycemia, the responses
to be seen in future study subjects, the possible expansion of
clinical testing to younger patients, the overall promise of XOMA
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
ghr.nlm.nih.gov/condition/congenital-hyperinsulinism. ii
www.chop.edu/conditions-diseases/congenital-hyperinsulinism/about#.VXncFU3bKHt.
iii
www.chop.edu/conditions-diseases/congenital-hyperinsulinism/about#.VXneYE3bKHu.
iv www.ojrd.com/content/pdf/1750-1172-6-63.pdf.
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:
Taryn Ibach
W2O Group
415-658-9748
tibach@w2ogroup.com
XOMA Royalty (NASDAQ:XOMA)
Historical Stock Chart
From Sep 2024 to Oct 2024
XOMA Royalty (NASDAQ:XOMA)
Historical Stock Chart
From Oct 2023 to Oct 2024