Addex Starts a Phase IIb Trial of ADX10059 for Migraine Prevention
GENEVA, SWITZERLAND -- (Marketwire) -- 12/17/08 -- Addex Pharmaceuticals (SWISS: ADXN),the allosteric modulation company, announced the start ofa Phase IIb trial of ADX10059 as a migraine prevention therapy inpeople who suffer from 3 or more migraine attacks per month. ADX10059is a first-in-class migraine prophylactic which works by inhibitingthe metabotropic glutamate receptor 5 (mGluR5) through negativeallosteric modulation (NAM). Addex believes mGluR5 may be a keyplayer in a neural process that initiates migraine headaches. Thus,this approach - inhibiting mGluR5 - may lead to a new class of drugsthat addresses the causes of migraine rather than just treating thesymptoms.
Chief Medical Officer Charlotte Keywood said: "We have already shownthat mGluR5 inhibition plays a relevant role in modifying thepathophysiology of migraine, when we observed significant efficacywith ADX10059 in a clinical proof of concept study for acutetreatment of migraine. This Phase IIb study will allow us to assessthe potential of ADX10059 in migraine prevention. This is anindication where there is a continuing large unmet medical need andwhere there no current treatments that are specifically targeted toinhibiting 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 whosuffer from three or more migraine attacks per month. Following a onemonth baseline period patients will take study medication for 3months. The primary endpoint will compare migraine frequency andseverity in the last month of treatment with the baseline. Data areexpected early in 2010.
Migraine
Migraine is a condition distinguished by recurrent episodes of acharacteristic headache, which can be accompanied by a variety ofother symptoms such as nausea, and sensitivity to light and sound.The average migraine patient suffers 12 attacks a year. TheInternational Headache Society estimates that about 25% of migrainepatients have three or more attacks per month and could benefit frommigraine prevention treatment. A migraine attack, which typicallylasts about 24 hours but can range from 4-72 hours, has threedistinct phases: the prodrome phase, when an array of individualwarning signs - like blurred vision or tingling of the skin - maybegin to appear; the headache phase; and the postdrome phase, whenmany patients report fatigue or other "hangover-like" symptoms. Asmigraine attacks are prolonged, many patients and especially thosewith frequent attacks, lose a significant amount of work and familytime to suffering caused by the disease. Indeed, migraine iscurrently estimated to cost employers $13 billion annually in lostproductivity in the United States. Prevalence of migraine isestimated at 12% in the United States, where about 30 million peoplesuffer from migraine.
mGluR5 inhibition
Research has shown that glutamate is the major neurotransmitterinvolved in the initiation and the propagation of the migrainecircuit, a positive feedback loop that leads to pain and inflammationin the brain and hence migraine symptoms. mGluR5 is known to beexpressed in key brain regions involved in the migraine circuit.Addex postulated that ADX10059 could interrupt the migraine circuitto abort an active attack and potentially prevent an attack frombeing triggered. ADX10059 has been shown by Addex to have a superioreffect to placebo in acute treatment of migraine headache in PhaseIIa testing. Inhibition of mGluR5 has therapeutic potential inmultiple indications because mGluR5 is involved in a variety offunctions in the central and peripheral nervous systems*. In additionto migraine, mGluR5 inhibitors have achieved clinical proof ofconcept in separate studies in patients with gastroesophageal refluxdisease (GERD), Parkinson's disease levodopa induced dyskinesia(PD-LID) and generalized anxiety disorder (GAD). Inhibition of mGluR5also has potential in Fragile X syndrome.
*mGluR5 antagonists: Discovery, characterization and drugdevelopment, Current Opinion in Drug Discovery & Development 200811(5):655-665
About Addex
Addex Pharmaceuticals (www.addexpharma.com) discovers and developsallosteric modulators for human health. Allosteric modulators are adifferent kind of orally available small molecule therapeutic agent,which we believe will offer patients better results than classicaldrugs. Our lead allosteric modulator product, ADX10059, has achievedclinical proof of concept for the treatment of GERD and migraine,both important diseases for which existing products with limitedefficacy have established multi-billion dollar markets despitesub-optimal benefits to patients.
Our products and technology already have proven their value throughour relationships with four of the best pharmaceutical companies inthe world. Specifically, in two separate agreements with Merck & Co.,Inc., signed in December 2007 and January 2008, we are developingallosteric modulators as drugs to treat Parkinson's disease andschizophrenia, respectively. A third agreement, with Johnson &Johnson, is focused on development of allosteric modulators to treatanxiety and schizophrenia. Separately, the investment funds of Rocheand GlaxoSmithKline have extended their validation of our technology,products and management by making significant investments in Addex.
ContactChris MaggosHead of IR & CommunicationsAddex Pharmaceuticals+41 22 884 15 [email protected]
Disclaimer
The foregoing release may contain forward-looking statements that canbe 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 discussionsregarding Addex Pharmaceuticals Ltd, its business, the potentialapproval of its products by regulatory authorities, or regardingpotential future revenues from such products. Such forward-lookingstatements reflect the current views of Addex Pharmaceuticals Ltdregarding 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 otherfactor that may materially differ from the plans, objectives,expectations, estimates and intentions expressed or implied in suchforward-looking statements. Such may in particular cause actualresults with allosteric modulators of mGluR2, mGluR4, mGluR5, mGluR7or other therapeutic targets to be materially different from anyfuture results, performance or achievements expressed or implied bysuch statements. There can be no guarantee that allosteric modulatorsof mGluR2, mGluR4, mGluR5, mGluR7 will be approved for sale in anymarket or by any regulatory authority. Nor can there be any guaranteethat allosteric modulators of mGluR2, mGluR4, mGluR5, mGluR7 or othertherapeutic targets will achieve any particular levels of revenue (ifany) in the future. In particular, management's expectationsregarding allosteric modulators of mGluR2, mGluR4, mGluR5, mGluR7 orother therapeutic targets could be affected by, among other things,unexpected actions by our partners, unexpected regulatory actions ordelays or government regulation generally; unexpected clinical trialresults, including unexpected new clinical data and unexpectedadditional analysis of existing clinical data; competition ingeneral; government, industry and general public pricing pressures;the company's ability to obtain or maintain patent or otherproprietary intellectual property protection. Should one or more ofthese risks or uncertainties materialize, or should underlyingassumptions prove incorrect, actual results may vary materially fromthose anticipated, believed, estimated or expected. AddexPharmaceuticals Ltd is providing the information in this pressrelease as of this date and does not undertake any obligation toupdate any forward-looking statements contained in this press releaseas a result of new information, future events or otherwise, except asmay be required by applicable laws.
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