Addex Starts a Phase IIb Trial of ADX10059 for Migraine Prevention

Deutsch (PDF)
Français (PDF)
English (PDF)

Geneva, Switzerland, 17 December 2008 - Addex Pharmaceuticals
(SWX:ADXN), the allosteric modulation company, announced the start of
a Phase IIb trial of ADX10059 as a migraine prevention therapy in
people who suffer from 3 or more migraine attacks per month. ADX10059
is a first-in-class migraine prophylactic which works by inhibiting
the metabotropic glutamate receptor 5 (mGluR5) through negative
allosteric modulation (NAM). Addex believes mGluR5 may be a key
player in a neural process that initiates migraine headaches. Thus,
this approach - inhibiting mGluR5 - may lead to a new class of drugs
that addresses the causes of migraine rather than just treating the
symptoms.

Chief Medical Officer Charlotte Keywood said: "We have already shown
that mGluR5 inhibition plays a relevant role in modifying the
pathophysiology of migraine, when we observed significant efficacy
with ADX10059 in a clinical proof of concept study for acute
treatment of migraine. This Phase IIb study will allow us to assess
the potential of ADX10059 in migraine prevention. This is an
indication where there is a continuing large unmet medical need and
where there no current treatments that are specifically targeted to
inhibiting neurotransmission in the migraine pathway."

Study ADX10059-206
Study 206 is a double-blind, placebo-controlled, dose range finding,
multi-center European Phase IIb trial in about 300 migraineurs who
suffer from three or more migraine attacks per month. Following a one
month baseline period patients will take study medication for 3
months. The primary endpoint will compare migraine frequency and
severity in the last month of treatment with the baseline. Data are
expected early in 2010.

Migraine
Migraine is a condition distinguished by recurrent episodes of a
characteristic headache, which can be accompanied by a variety of
other symptoms such as nausea, and sensitivity to light and sound.
The average migraine patient suffers 12 attacks a year. The
International Headache Society estimates that about 25% of migraine
patients have three or more attacks per month and could benefit from
migraine prevention treatment. A migraine attack, which typically
lasts about 24 hours but can range from 4-72 hours, has three
distinct phases: the prodrome phase, when an array of individual
warning signs - like blurred vision or tingling of the skin - may
begin to appear; the headache phase; and the postdrome phase, when
many patients report fatigue or other "hangover-like" symptoms. As
migraine attacks are prolonged, many patients and especially those
with frequent attacks, lose a significant amount of work and family
time to suffering caused by the disease. Indeed, migraine is
currently estimated to cost employers $13 billion annually in lost
productivity in the United States. Prevalence of migraine is
estimated at 12% in the United States, where about 30 million people
suffer from migraine.

mGluR5 inhibition
Research has shown that glutamate is the major neurotransmitter
involved in the initiation and the propagation of the migraine
circuit, a positive feedback loop that leads to pain and inflammation
in the brain and hence migraine symptoms. mGluR5 is known to be
expressed in key brain regions involved in the migraine circuit.
Addex postulated that ADX10059 could interrupt the migraine circuit
to abort an active attack and potentially prevent an attack from
being triggered. ADX10059 has been shown by Addex to have a superior
effect to placebo in acute treatment of migraine headache in Phase
IIa testing. Inhibition of mGluR5 has therapeutic potential in
multiple indications because mGluR5 is involved in a variety of
functions in the central and peripheral nervous systems*. In addition
to migraine, mGluR5 inhibitors have achieved clinical proof of
concept in separate studies in patients with gastroesophageal reflux
disease (GERD), 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.