PLAN-LES-OUATES GENEVA, SWITZERLAND--(Marketwire - Mar 21, 2013) -
Addex Therapeutics /
Addex Therapeutics Announces Presentation of Dipraglurant Phase 2a StudyResultsat the 2013 Annual Meeting of the American Academy of Neurology (AAN)
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$1 MM grant by The Michael J. Fox Foundation to be used to help fundfurtherhuman clinical testing of dipraglurant for the treatment of Parkinson'sdiseaselevodopa-induced dyskinesia
Geneva, Switzerland, 21 March 2013 - Addex Therapeutics (
"We believe the successful completion of the Phase 2a study showedsignificantpromise that dipraglurant has the potential to change the way thesepatients aretreated as well as their quality of life," said Graham Dixon, Ph.D.,ChiefScientific Officer of Addex Therapeutics. "The clinical studies that weplan tocomplete in the coming months, supported in part by the grantfrom TheFoundation, are critical to our continued advancement of this importantapproachfor the treatment of PD-LID."
Dipraglurant is an oral, small molecule allosteric modulator thatinhibitsselectively the metabotropic glutamate receptor 5 (mGlu5), a Class C G-ProteinCoupled Receptor (GPCR). The Phase 2a trial was a randomised, double-blind,placebo-controlled study in 76 patients with moderate to severe levodopa-induceddyskinesia conducted at 25 sites in Europe and the United States.In thepresentation at the AAN conference, Professor Tison reported that thestudy metthe primary objectives of safety and tolerability at both 50 and 100mgdoses;supporting further clinical testing in this patient population. Inaddition,dipraglurant demonstrated positive anti-dyskinetic effect measured byobserverevaluated mAIMS, patient reported diary data and patient and clinicianglobalimpression of change scales. Further, there was no negativeeffect onParkinsonism and the data suggested that dipraglurant provided abeneficialeffect on motor fluctuation. Addex has previously reported top-lineresultsfrom this study last year. The Phase 2a study was supported by a $900,000grantfrom The Michael J. Fox Foundation for Parkinson's Research.
"We continue to be engaged in partnering discussions with a number ofglobalplayers who we believe have the expertise and capability to fullyexploitdipraglurant and expect to have a deal completed sometime this year,"saidBharatt Chowrira, Ph.D., Chief Executive Officer of Addex Therapeutic."While wecontinue to advance this compound for PD-LID we will also initiateparallelclinical efforts for a rare form of dystonia. We expect to initiate aPhase 2study in dystonia and report data by the end of 2013. Completion of thePD-LIDclinical work as well as the dystonia study will bring significant valueto ourdipraglurant franchise."
About Addex Therapeutics
Addex Therapeutics (www.addextherapeutics.com) is a development stagecompanyfocused on advancing innovative oral small molecules against rarediseasesutilizing its pioneering allosteric modulation-based drug discoveryplatform.The Company's two lead products are being investigated in Phase 2clinicaltesting: dipraglurant (dipraglurant, an mGlu5 negative allostericmodulator orNAM) is being developed by Addex to treat Parkinson's disease levodopa-induceddyskinesia (PD-LID) and rare forms of dystonia; and ADX71149 (mGlu2positiveallosteric modulator or PAM) is being developed in collaboration withJanssenPharmaceuticals, Inc. to treat both schizophrenia and anxiety asseen inpatients suffering from major depressive disorder. Addex is alsoadvancingseveral preclinical programs including: GABA-BR positive allostericmodulator(PAM) for Charcot-Marie-Tooth (type 1a) disease, spasticity in patientswithmultiple sclerosis (MS), pain, overactive bladder and other disorders; andmGlu4PAM for MS, Parkinson's disease, anxiety and other diseases.Allostericmodulators are an emerging class of small molecule drugs whichhave thepotential to be more specific and confer significant therapeutic advantagesoverconventional "orthosteric" small molecule or biological drugs. The Companyusesits proprietary discovery platform to target receptors and other proteinsthatare recognized as essential for the therapeutic modulation of importantdiseaseswith unmet medical needs.
Disclaimer: The foregoing release may contain forward-looking statementsthatcan 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 regardingAddexTherapeutics, formerly known as, Addex Pharmaceuticals, its business, thepotential approval of its products by regulatory authorities, or regardingpotential future revenues from such products. Such forward-lookingstatementsreflect the current views of Addex Therapeutics regarding future events,futureeconomic performance or prospects, and, by their very nature, involveinherentrisks and uncertainties, both general and specific, whether known orunknown,and/or any other factor that may materially differ from the plans,objectives,expectations, estimates and intentions expressed or implied in suchforward-looking statements. Such may in particular cause actual results withallostericmodulators of mGlu2, mGlu4, mGlu5, GABA-BR or other therapeutic targets tobematerially different from any future results, performance or achievementsexpressed or implied by such statements. There can be no guarantee thatallosteric modulators of mGlu2, mGlu4, mGlu5, GABA-BR or other therapeuticstargets will be approved for sale in any market or by any regulatoryauthority.Nor can there be any guarantee that allosteric modulators of mGlu2, mGlu4,mGlu5, GABA-BR or other therapeutic targets will achieve any particularlevelsof revenue (if any) in the future. In particular, management's expectationsregarding allosteric modulators of mGlu2, mGlu4, mGlu5, GABA-BR or othertherapeutic targets could be affected by, among other things, unexpectedactionsby our partners, unexpected regulatory actions or delays or governmentregulation generally; unexpected clinical trial results, including unexpectednew clinical data and unexpected additional analysis of existing clinicaldata;competition in general; government, industry and general public pricingpressures; the company's ability to obtain or maintain patent or otherproprietary intellectual property protection. Should one or more of theserisksor uncertainties materialize, or should underlying assumptions proveincorrect,actual results may vary materially from those anticipated, believed,estimatedor expected. Addex Therapeutics is providing the information in this pressrelease as of this date and does not undertake any obligation to update anyforward-looking statements contained in this press release as a result ofnewinformation, future events or otherwise, except as may be required byapplicablelaws.
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