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ADDEX PHARMACEUTIC : Starts Phase IIb ADX10059, Proton Pump Inhibitor Combination Study in GERD Patients

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12/02/2008 | 07:01am CEST

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Geneva, Switzerland, 2 December 2008 - Addex Pharmaceuticals
(SWX:ADXN), the allosteric modulation company, started today a Phase
IIb trial of ADX10059 as an add-on therapy to proton pump inhibitors
(PPIs) for the treatment of gastroesophageal reflux disease (GERD),
the cause of heartburn and other symptoms. The standard dose of PPI
does not control GERD adequately in about 40% of patients. ADX10059
is a first-in-class reflux inhibitor that works by selectively
inhibiting the metabotropic glutamate receptor 5 (mGluR5) through
negative allosteric modulation. This approach may lead to a new class
of drugs that addresses the causes of GERD rather than the symptoms.

Chief Medical Officer Charlotte Keywood said: "The aim of this trial
is to give us information on the clinical effects of reflux
inhibition by an mGluR5 inhibitor in patients who continue to have
breakthrough symptoms whilst on PPIs. This study also may provide
information on the most appropriate dose of ADX10059."

Study ADX10059-205
Study 205 is a double-blind, placebo-controlled, multi-center U.S.
and European Phase IIb trial in about 280 GERD patients who are
partial responders to proton pump inhibitors (PPIs). Patients in the
trial will continue taking PPIs, the gold standard treatment for
GERD, which work by reducing the acidity of the stomach contents.
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 are expected to be reported in late 2009.

Gastroesphageal 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 content
to pass back into the esophagus too easily. 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
As with other glutamate receptors, mGluR5 is involved in a variety of
functions in the central and peripheral nervous systems. In GERD,
inhibition of mGluR5 aims to restore normal function and improve the
tone of the LES muscle thereby addressing the cause of disease.
Indeed, ADX10059 has been shown by Addex to reduce reflux and reduce
esophageal acid exposure in two separate clinical trials. Research
has also 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. Inhibiting mGluR5 also has therapeutic potential for
levodopa associated dyskinesia in Parkinson's disease, migraine
headache, Fragile X and other diseases.

About Addex
Addex Pharmaceuticals (www.addexpharma.com) discovers and develops
allosteric modulators, an emerging class of small molecule
therapeutic agents. Allosteric modulation may offer more
sophisticated ways to normalize biological signaling compared to
classical orthosteric agonist or antagonist drugs. Allosteric,
literally translated from its Greek roots, means "other site". Thus,
allosteric modulators bind receptors at sites that are distinct from
the binding sites of classical small molecule orthosteric agonist and
antagonist drugs.

The most advanced drug candidate, ADX10059, a negative allosteric
modulator (NAM) of metabotropic glutamate receptor 5 (mGluR5), has
demonstrated clinically and statistically significant efficacy in
separate Phase IIa clinical trials in gastroesophageal reflux disease
(GERD) patients and migraine headache patients. It also will start
Phase IIb testing for migraine prevention during the fourth quarter
of 2008.

The Addex allosteric modulation discovery and development platform
has been additionally validated through three separate product
license agreements with Merck & Co., Inc. and Johnson & Johnson as
well as investments by Roche Ventures and SR One, the venture
investment arm of GlaxoSmithKline.

Chris Maggos
Head of IR & Communications
Addex Pharmaceuticals
+41 22 884 15 11
[email protected]

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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