Addex Presents ADX10059 PD-LID Data at GPCR Drug Discovery Conference
(Thomson Reuters ONE) - Corporate news announcement processed and transmitted by Hugin AS.The issuer is solely responsible for the content of this announcement. ------------------------------------------------------------------------------------ ADX10059 inhibited both chorea and dystonia induced by levodopa whilemaintaining the anti-parkinsonian effect of levodopa on PD symptomsGeneva, Switzerland, 3 November 2009 - Addex Pharmaceuticals(SWX:ADXN), the allosteric modulation company, presented resultstoday from studies of its lead clinical candidate, ADX10059, inanimal models of Parkinson's disease levodopa induced dyskinesia(PD-LID) at the Discovery on Target GPCR-based Drug Discoveryconference in Boston. Addex disclosed for the first time that in anon-human primate model of PD-LID, ADX10059 had a statisticallysignificant impact on dystonia, a neurological movement disorder seenin Parkinson's disease and other conditions, including generalizeddystonia, tardive dyskinesia, levodopa non responsive PD syndrome andmultiple system atrophy. There is no approved treatment available forPD-LID.ADX10059 is the first-in-class negative allosteric modulator (NAM) ofmetabotropic glutamate receptor 5 (mGluR5), a mechanism that is beingtested in multiple indications by Addex and competitors. ADX10059 iscurrently being evaluated in Phase IIb clinical trials for thetreatment of gastroesophageal reflux disease (GERD) and to preventmigraine. Separate announcements of data from the two ongoing GERDtrials are expected before year-end and early in 2010. The migrainestudy will report data early in the second quarter of 2010.Addex disclosed earlier this year that ADX10059 demonstratedsignificant efficacy in well-established preclinical models of PD andPD-LID. Importantly, these effects in PD and PD-LID were seen atdoses and plasma concentrations that have shown efficacy in bothclinical and preclinical studies with the compound in otherindications. The effects on dystonia announced today differentiatethe Addex mGluR5 inhibitor within the PD indication but also presentpotential development opportunities for treatment of other types ofdystonia.The oral slide presentation today will show that in the non-humanprimate MPTP model of PD-LID, all doses of ADX10059 abolished LIDduring the first hour following L-DOPA administration and a doseresponse was observed during the second hour, reaching statisticalsignificance for the two higher doses tested. Statisticallysignificant reductions were seen for both chorea and dystonia in adose dependent fashion. Similar effects on dystonia have notpreviously been reported in this model with drug-like moleculeseither in development or on the market.When tested in the rat model, oral administration of ADX10059dose-dependently reversed the catalepsy induced by haloperidol inthree independent experiments.Dystonia is a neurologic movement disorder characterized by sustainedmuscle contractions that frequently cause twisting or repetitivemovements and abnormal, sometimes painful, postures or positions.Dystonia may affect any part of the body including the arms, legs,trunk, neck, head, or face.PD-LID develops in most PD patients after receiving levodopa forseveral years. It is a complication caused by dopamine replacementtherapy (i.e. levodopa). The two main components of LID are choreaand dystonia. Chorea is manifest as abnormal involuntary movements.Currently there are an estimated 1.2 million patients with PD-LID inthe U.S.PD is a degenerative disease of the brain that often impairs motorskills, speech, and other functions. It is estimated that 60,000 newcases are diagnosed each year in the U.S., where more than 1.5million people currently have PD. While the condition usuallydevelops after the age of 65, 15% of those diagnosed are under 50. PDaffects both men and women in almost equal numbers.mGluR5 inhibition reduces signaling activity of the neurotransmitterglutamate. Marketed blockbuster drugs treat multiple indications bytargeting other types of neurotransmitter signaling, includingselective serotonin reuptake inhibitors (SSRIs) used to treatdepression and dopamine receptor inhibitors used to treatschizophrenia. The rationale for using mGluR5 inhibition in PD isthat the loss of dopamine producing cells leads to excessglutamatergic stimulation in the brain's "striatopallidal pathway".mGluR5 are found abundantly in the striatum and are implicated in theexcess glutamate activity in Parkinson's Disease. Research shows thatinhibition of glutamate stimulation in this pathway has generatedanti-Parkinsonian effects in animal models of PD and PD-LID, and inhumans with PD-LID.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 a competitive advantage over classicaldrugs. Our lead allosteric modulator product, ADX10059, has achievedclinical proof of concept and is in Phase IIb testing for thetreatment of GERD and, separately, migraine headache. ADX10059 is afirst-in-class mGluR5 inhibitor, a therapeutic strategy that also isbeing pursued in multiple indications by large pharma competitors.Our products and technology already have proven their value throughour relationships with four of the top 10 pharmaceutical companies inthe world. Specifically, under an agreement with Ortho-McNeil-JanssenInc., a Johnson & Johnson company, ADX71149, a positive allostericmodulator (PAM) of mGluR2, is undergoing Phase I clinical testing andhas potential for treatment of schizophrenia and anxiety. Under twoseparate agreements with Merck & Co., Inc., we are developing PAMs ofmGluR4 and mGluR5 as drugs to treat Parkinson's disease andschizophrenia, respectively. In addition, GlaxoSmithKline and Rochehave made equity investments in Addex.Chris MaggosInvestor Relations & CommunicationsAddex Pharmaceuticals+41 22 884 15 11chris.maggos(at)addexpharma.comDisclaimer: The foregoing release contains forward-looking statementsthat can be identified by terminology such as "not approvable","continue", "believes", "believe", "will", "remained open toexploring", "would", "could", or similar expressions, or by expressor implied discussions regarding Addex Pharmaceuticals Ltd, itsbusiness, the potential approval of its products by regulatoryauthorities, or regarding potential future revenues from suchproducts. Such forward-looking statements reflect the current viewsof Addex Pharmaceuticals Ltd regarding future events, and involveknown and unknown risks, uncertainties and other factors that maycause actual results with allosteric modulators of mGluR4, mGluR2,mGluR5 or other therapeutic targets to be materially different fromany future results, performance or achievements expressed or impliedby such statements. There can be no guarantee that allostericmodulators of mGluR4, mGluR2 or mGluR5 will be approved for sale inany market or by any regulatory authority. Nor can there be anyguarantee that allosteric modulators of mGluR4, mGluR2, mGluR5 orother therapeutic targets will achieve any particular levels ofrevenue (if any) in the future. In particular, management'sexpectations regarding allosteric modulators of mGluR4, mGluR2,mGluR5 or other therapeutic targets could be affected by, among otherthings, unexpected actions by our partners, unexpected regulatoryactions or delays or government regulation generally; unexpectedclinical trial results, including unexpected new clinical data andunexpected additional analysis of existing clinical data; competitionin general; government, industry and general public pricingpressures; the company's ability to obtain or maintain patent orother proprietary intellectual property protection. Should one ormore of these risks or uncertainties materialize, or shouldunderlying assumptions prove incorrect, actual results may varymaterially from those anticipated, believed, estimated or expected.Addex Pharmaceuticals 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. --- End of Message ---Addex Pharmaceuticals12, chemin des Aulx Plan-les-Ouates, Geneva SwitzerlandISIN: CH0029850754; Index: SLIFE, SPI, SPIEX, SSCI;Listed: Main Market in SIX Swiss Exchange;
Datum: 03.11.2009 - 07:00 Uhr
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