Addex ADX48621 Positive Primate Parkinson's Data
(Thomson Reuters ONE) - Corporate news announcement processed and transmitted by Hugin AS.The issuer is solely responsible for the content of this announcement. ------------------------------------------------------------------------------------ ADX48621 shows efficacy on both chorea and dystonia in PD-LID modelGeneva, Switzerland, 24 November 2009 - Addex Pharmaceuticals(SWX:ADXN), the allosteric modulation company, announced today thatin a non-human primate model of Parkinson's disease (PD) levodopainduced dyskinesia (LID), ADX48621 statistically and significantlyinhibited LID. More specifically, the compound inhibited dosedependently both chorea and dystonia, the two major components ofLID, without affecting the beneficial effects of levodopa. There iscurrently no approved treatment available for PD-LID. ADX48621 is ametabotropic glutamate receptor 5 (mGluR5) negative allostericmodulator (NAM) that has completed Phase I testing and is scheduledto start Phase IIa testing in Parkinson's disease next year.In the non-human primate MPTP model of PD-LID, the highest dose ofADX48621 (30mg/kg) abolished LID over the course of the experimentand a dose response was observed during the first two hours, reachingstatistical significance for the highest dose tested. Importantly,statistically significant reductions were seen for both chorea anddystonia in a dose dependent fashion.Addex reported earlier this year that when tested in a rat model,oral administration of ADX48621 dose-dependently reversed thecatalepsy induced by haloperidol in three independent experiments.These data indicate that ADX48621 has potential as a treatment forParkinsonian symptoms as well as LID symptoms.Although other drug candidates have shown some efficacy on chorea,similar effects on dystonia have not previously been reported in thismodel with drug-like molecules either in development or on themarket, (except with ADX10059, another mGluR5 NAM from Addex).ADX48621 is a next-stage mGluR5 NAM, which was generated from aseparate chemical scaffold than ADX10059; both mGluR5 NAM havesimilar selectivity and activity at the target receptor. Addex' leadproduct ADX10059 is in Phase IIb development for gastroesophagealreflux disease (GERD) and migraine prevention. Addex plans to moveADX48621 forward in PD-LID, PD and dystonia.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.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.Dystonia is a neurologic movement disorder characterized by sustainedmuscle contractions that frequently cause twisting or repetitivemovements and abnormal, sometimes painful, postures or positions.Currently there are an estimated 1.2 million patients with PD-LID inthe U.S.mGluR5 inhibition reduces signaling activity of the neurotransmitterglutamate. Marketed blockbuster drugs treat multiple indications bytargeting other types of neurotransmitter signaling, includingselecitive 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.http://hugin.info/138017/R/1356772/329850.pdfhttp://hugin.info/138017/R/1356772/329851.pdfhttp://hugin.info/138017/R/1356772/329852.pdf --- 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: 24.11.2009 - 07:00 Uhr
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