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Addex Starts a Second Phase IIb Trial of ADX10059 in GERD |
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Geneva, Switzerland, 17 December 2008 - Addex Pharmaceuticals
(SWX:ADXN), the allosteric modulation company, announced the start of
a Phase IIb trial of ADX10059 monotherapy in patients with
gastroesophageal reflux disease (GERD), the cause of heartburn and
other symptoms. ADX10059 is a first-in-class reflux inhibitor that
works by reducing activation of the metabotropic glutamate receptor 5
(mGluR5) through negative allosteric modulation (NAM). This approach
may lead to a new class of drugs that addresses the causes of GERD
rather than just the symptoms.
Chief Medical Officer Charlotte Keywood said: "We have already
observed significant efficacy with ADX10059 in two clinical studies
in GERD. This Phase IIb study will allow us to assess the potential
of ADX10059 as a stand alone treatment for clinical symptom control
in GERD sufferers as well as further understand how ADX10059 works on
lower esophageal sphincter function."
Study ADX10059-204
Study 204 is a double-blind, placebo-controlled, multi-center
European Phase IIb trial in about 90 GERD patients known to respond
well to proton pump inhibitors (PPIs). There will be a two week
baseline symptom evaluation period followed by two weeks of
administration of ADX10059 120 mg twice daily. ADX10059 will be used
as a monotherapy so patients in the study will not use PPIs or other
acid suppressant therapy during the baseline and study treatment
periods. The primary endpoint is patient reported symptom control
compared to baseline. Objective measures of the effects of ADX10059
on lower esophageal sphincter (LES) function and acid reflux events
will be made in a subset of patients using esophageal manometry and
pH impedance monitoring.
Addex announced on December 2 the start of Study 205, a double-blind,
placebo-controlled, multi-center U.S. and European Phase IIb trial in
about 280 GERD patients who are partial responders to PPIs. In Study
205 ADX10059 is being used as an add-on therapy to the patients'
existing PPI treatment. There will be a baseline symptom evaluation
period followed by four weeks of administration of twice-daily
ADX10059 (50mg, 100mg or 150mg). The primary endpoint is patient
reported symptom control compared to baseline. Data for both studies
are expected to be reported in late 2009.
GERD
Gastroesophageal reflux disease (GERD) is a chronic condition caused
by stomach contents flowing back into the esophagus on a regular
basis. The underlying cause of this is an abnormally functioning
lower esophageal sphincter (LES) muscle that allows stomach contents
to pass too easily back into the esophagus. GERD leads to painful
symptoms like heartburn and can also damage the lining of the
esophagus. It is a common disorder with prevalence at about 15% in
the United States and between 10% and 25% in Europe. Marketed GERD
products work by reducing the acidity of the stomach contents but do
nothing to reduce reflux events, so that in many patients symptoms of
GERD persist.
mGluR5 inhibition
In GERD, inhibition of mGluR5 aims to restore normal function of the
LES muscle thereby preventing reflux and addressing the cause of the
disease. Indeed, ADX10059 has been shown by Addex to reduce reflux
and reduce esophageal acid exposure in two separate clinical trials.
Research has shown that mGluR5 inhibition improves LES function in
animals. Reflux inhibitors have been recognized as potentially being
the next generation GERD therapy because they address the cause of
the disease and are complementary to marketed acid suppression
therapies. Inhibition of mGluR5 has therapeutic potential in multiple
other indications because, as with other glutamate receptors, mGluR5
is involved in a variety of functions in the central and peripheral
nervous systems*. In addition to GERD, mGluR5 inhibitors have
achieved clinical proof of concept in separate studies in patients
with migraine headache, Parkinson's disease levodopa induced
dyskinesia (PD-LID) and generalized anxiety disorder (GAD).
Inhibition of mGluR5 also has potential in Fragile X syndrome.
*mGluR5 antagonists: Discovery, characterization and drug
development, Current Opinion in Drug Discovery & Development 2008
11(5):655-665
About Addex
Addex Pharmaceuticals (www.addexpharma.com) discovers and develops
allosteric modulators for human health. Allosteric modulators are a
different kind of orally available small molecule therapeutic agent,
which we believe will offer patients better results than classical
drugs. Our lead allosteric modulator product, ADX10059, has achieved
clinical proof of concept for the treatment of GERD and migraine,
both important diseases for which existing products with limited
efficacy have established multi-billion dollar markets despite
sub-optimal benefits to patients.
Our products and technology already have proven their value through
our relationships with four of the best pharmaceutical companies in
the world. Specifically, in two separate agreements with Merck & Co.,
Inc., signed in December 2007 and January 2008, we are developing
allosteric modulators as drugs to treat Parkinson's disease and
schizophrenia, respectively. A third agreement, with Johnson &
Johnson, is focused on development of allosteric modulators to treat
anxiety and schizophrenia. Separately, the investment funds of Roche
and GlaxoSmithKline have extended their validation of our technology,
products and management by making significant investments in Addex.
Contact
Chris Maggos
Head of IR & Communications
Addex Pharmaceuticals
+41 22 884 15 11
chris.maggos@addexpharma.com
Disclaimer
The foregoing release may contain forward-looking statements that can
be identified by terminology such as "not approvable", "continue",
"believes", "believe", "will", "remained open to exploring", "would",
"could", or similar expressions, or by express or implied discussions
regarding Addex Pharmaceuticals Ltd, its business, the potential
approval of its products by regulatory authorities, or regarding
potential future revenues from such products. Such forward-looking
statements reflect the current views of Addex Pharmaceuticals Ltd
regarding future events, future economic performance or prospects,
and, by their very nature, involve inherent risks and uncertainties,
both general and specific, whether known or unknown, and/or any other
factor that may materially differ from the plans, objectives,
expectations, estimates and intentions expressed or implied in such
forward-looking statements. Such may in particular cause actual
results with allosteric modulators of mGluR2, mGluR4, mGluR5, mGluR7
or other therapeutic targets to be materially different from any
future results, performance or achievements expressed or implied by
such statements. There can be no guarantee that allosteric modulators
of mGluR2, mGluR4, mGluR5, mGluR7 will be approved for sale in any
market or by any regulatory authority. Nor can there be any guarantee
that allosteric modulators of mGluR2, mGluR4, mGluR5, mGluR7 or other
therapeutic targets will achieve any particular levels of revenue (if
any) in the future. In particular, management's expectations
regarding allosteric modulators of mGluR2, mGluR4, mGluR5, mGluR7 or
other therapeutic targets could be affected by, among other things,
unexpected actions by our partners, unexpected regulatory actions or
delays or government regulation generally; unexpected clinical trial
results, including unexpected new clinical data and unexpected
additional analysis of existing clinical data; competition in
general; government, industry and general public pricing pressures;
the company's ability to obtain or maintain patent or other
proprietary intellectual property protection. Should one or more of
these risks or uncertainties materialize, or should underlying
assumptions prove incorrect, actual results may vary materially from
those anticipated, believed, estimated or expected. Addex
Pharmaceuticals Ltd is providing the information in this press
release as of this date and does not undertake any obligation to
update any forward-looking statements contained in this press release
as a result of new information, future events or otherwise, except as
may be required by applicable laws.
This announcement was originally distributed by Hugin. The issuer is
solely responsible for the content of this announcement. Copyright © Hugin AS 2008. All rights reserved.
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