Addex R&D Day Highlights Broadened Therapeutic Potential of
Allosteric Modulation Platform to Includ
Addex R&D Day Highlights Broadened Therapeutic Potential of Allosteric Modulation Platform to Include Cytokine Receptors as well as GPCRs
(Thomson Reuters ONE) - Corporate news announcement processed and transmitted by Hugin AS.The issuer is solely responsible for the content of this announcement. ------------------------------------------------------------------------------------ Webcast at www.addexpharma.com from 11am CEST to 3:30 pm CESTDeutsch (PDF)Français (PDF)English (PDF)Geneva, Switzerland, 16 July 2009 - At its R&D Day today, allostericmodulation company Addex Pharmaceuticals (SIX:ADXN) will disclose forthe first time the successful adaptation of its innovative andproprietary allosteric modulator platform beyond G-protein coupledreceptors (GPCR) targets to include discovery of orally active, smallmolecule drugs targeting type I transmembrane proteins, includingcytokine receptors. GPCR and cytokine receptors are among the mostimportant therapeutic targets, with many drugs against these types ofreceptors on the market or in development. Addex also will provide astatus report on all of its clinical and earlier stage programs."In addition to expanding our efforts beyond the mGluRs to includesome equally challenging GPCR targets, like the A2A receptor and theOrexin 2 receptor, we have successfully adapted our proprietaryscreening platform to include receptor targets like TNF-R1, IL-1R1,GIPR and GLP-1R that have previously only been addressed by proteinor peptide therapeutics," said Vincent Mutel, CEO of Addex. "Webelieve allosteric modulators will provide drug makers a bridgetraversing the gap between classical small molecule drugs and proteintherapeutics, offering potential for a totally new kind of highlydifferentiated therapeutic class. We intend to leverage of ourfirst-mover advantage in developing tools to discover this new classof small molecule drugs in order to retain important intellectualproperty and forge exciting new partnerships."Proprietary Discovery Platform ProgressAddex has executed on its plan announced at the April 2008 R&D Day toorganize itself into three business units (CNS, Inflammation andMetabolic Disorders), supported by Core Biology and Core Chemistryteams for discovery and medicinal chemistry. As programs progress,non-clinical and clinical development teams are charged withdeveloping projects coming out of discovery. This structure allowsfor efficient use of resources and has enabled broadening the scopeof the platform into new therapeutic targets while reducing the needto spread highly specialized proprietary tools and expertise acrossmultiple departments.Addex' Core Biology in collaboration with researchers in theInflammation Business Unit have developed new proprietary discoverytools to identify negative allosteric modulators of Tumor NecrosisFactor-Receptor 1 (TNF-R1), an important therapeutic target inrheumatoid arthritis (RA) and other inflammatory diseases. The firstscreening has been completed and primary hits have been identified.To date, successful targeting of TNF has only been achieved usinglarge molecule biological drugs, or so called protein therapeutics,which need to be injected and have a high cost of goods compared toorally available small molecule drugs.The same interdisciplinary team has adapted this proprietarytechnology to identify adenosine 2A receptor (A2AR) positiveallosteric modulators (PAM). The first screening has been completedand primary hits have been identified. The same tools are now beingadapted to screen the interleukin-1 receptor 1 (IL-1R1). TNF-R1 NAM,A2AR PAM and IL-1R1 NAM programs have potential for the treatment ofRA and other inflammatory diseases like psoriasis, osteoarthritis,gout and even Alzheimer's disease or Type II diabetes.Similarly, Core Biology, working with the Metabolic Disorders Unit,have used Addex' proprietary tools to discover Gastric InhibitoryPolypeptide Receptor (GIPR) allosteric agonist and continueoptimization of glucagon-like peptide 1 receptor (GLP-1R) PAM. Bothprograms have potential to treat Type II Diabetes."We believe these carefully tailored proprietary screening assays,together with our unique growing allostery biased library, willenable us to continue to target a broad range of well validatedimportant therapeutic targets that were not previously accessible tosmall molecule chemistry," said CEO Vincent Mutel.With the CNS Business unit, Addex' proprietary assays have beenadapted for screening of Orexin-2 receptor NAM, which has potentialfor the treatment of sleep disorders. The first screening has beencompleted and primary hits have been identified. In addition, theoptimization of metabotropic glutamate receptor 4 (mGluR4) PAM (partof a collaboration with Merck & Co., Inc. to develop drugs forParkinson's disease and undisclosed indications) continues to moveforward; last week Addex announced that mGluR4 PAM showed activity asa non-dopaminergic drug after oral administration in an animal modelof PD, thereby achieving a second preclinical milestone. The CNSBusiness Unit also has progressed optimization of its mGluR2 NAM,with potential for cognitive deficits in Alzheimer's disease and fordepression as well as mGluR7 NAM, which have potential for treatmentof depression and post-traumatic-stress disorder.Significant progress has been made in studying ADX68692, a folliclestimulating hormone (FSH) NAM. New data to be presented today suggestthat the product might be suited for treatment of hormone refractoryprostate cancer. In vivo proof of concept studies for hormonerefractory prostate cancer will continue, while development ofADX68692 in other indications, such as contraception and osteoporosiswill be put on hold.Previously undisclosed projects for obesity and migraine have alsobeen put on hold to prioritize other programs. Addex has terminateddevelopment of its Adenosine A3 antagonist for glaucoma but continuesto make the product available for out-licensing.Clinical ProgramsEnrollment in the three Phase IIb trials of ADX10059 in both GERD andmigraine prevention is proceeding as planned. The data from the twoGERD studies are expected in the fourth quarter of 2009. The datafrom the migraine prevention study are expected in the first half of2010.Preclinical data, disclosed for the first time today, show that bothADX10059 and ADX48621 reversed haloperidol induced catalepsy in arodent model of Parkinson's disease (PD). Data from ongoing studiesin a primate monkey model of PD are expected in the coming months.ADX10059 and ADX48621 are mGluR5 NAM. ADX48621 completed Phase Itesting in healthy volunteers earlier this year and is scheduled tostart Phase IIa testing in PD patients before the end of 2009.Addex partner, Ortho-McNeil-Janssen Pharmaceuticals Inc., a Johnson &Johnson company, started last month Phase I testing of ADX71149, anmGluR2 PAM with potential for treatment of schizophrenia and anxiety.R&D Day webcastsThe live webcasts, slides and recorded webcasts will be available viawww.addexpharma.com.The webcast program is as follows (times are Central European SummerTime):11:00 Overview (Vincent Mutel, Chief Executive Officer)11:30 Allostery Platform: Chemistry (Jean-Philippe Rocher, Head of Core Chemistry)12:00 Allostery Platform: Biology (Robert Lütjens, Head of Core Biology)12:30 Inflammation Business Unit (Laurent Galibert, Head of Inflammation)13:00 Lunch Break13:30 Metabolic Disease Business Unit (Vincent Mutel, CEO & acting Head of Metabolic Disorders)14:00 CNS Business Unit (Emmanuel Le Poul, Head of CNS)14:30 Non-clinical Development (Sonia Poli, Head of Non-Clinical Development)15:00 Clinical Development (Charlotte Keywood, Chief Medical Officer)15:30 Conclusion (Vincent Mutel, Chief Executive Officer)Questions will be invited during each presentation. Webcast viewersalso will be able to ask questions, at any time, using an instantmessenger located in the webcast browser window. Recordings andslides will be made available via www.addexpharma.com.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. Both areimportant diseases for which existing products with limited efficacyhave established multi-billion dollar markets despite sub-optimalefficacy. ADX10059 is a first-in-class mGluR5 inhibitor, atherapeutic strategy that also is being pursued in multipleindications 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 MaggosHead of IR & CommunicationsAddex Pharmaceuticals+41 22 884 15 11chris.maggos(at)addexpharma.comDisclaimer: The foregoing release may contain forward-lookingstatements that can be identified by terminology such as "notapprovable", "continue", "believes", "believe", "will", "remainedopen to exploring", "would", "could", or similar expressions, or byexpress or implied discussions regarding Addex Pharmaceuticals Ltd,its business, 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, future economicperformance or prospects, and, by their very nature, involve inherentrisks and uncertainties, both general and specific, whether known orunknown, and/or any other factor that may materially differ from theplans, objectives, expectations, estimates and intentions expressedor implied in such forward-looking statements. Such may in particularcause actual results with allosteric modulators of mGluR2, mGluR4,mGluR5, mGluR7 or other therapeutic targets to be materiallydifferent from any future results, performance or achievementsexpressed or implied by such statements. There can be no guaranteethat allosteric modulators of mGluR2, mGluR4, mGluR5, mGluR7 will beapproved for sale in any market or by any regulatory authority. Norcan there be any guarantee that allosteric modulators of mGluR2,mGluR4, mGluR5, mGluR7 or other therapeutic targets will achieve anyparticular 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 affectedby, among other things, unexpected actions by our partners,unexpected regulatory actions or delays or government regulationgenerally; unexpected clinical trial results, including unexpectednew clinical data and unexpected additional analysis of existingclinical data; competition in general; government, industry andgeneral public pricing pressures; the company's ability to obtain ormaintain patent or other proprietary intellectual propertyprotection. Should one or more of these risks or uncertaintiesmaterialize, or should underlying assumptions prove incorrect, actualresults may vary materially from those anticipated, believed,estimated or expected. Addex Pharmaceuticals Ltd is providing theinformation in this press release as of this date and does notundertake any obligation to update any forward-looking statementscontained in this press release as a result of new information,future events or otherwise, except as may be required by applicablelaws.http://hugin.info/138017/R/1329035/313642.pdfhttp://hugin.info/138017/R/1329035/313645.pdfhttp://hugin.info/138017/R/1329035/313648.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: 16.07.2009 - 07:00 Uhr
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