Addex completes enrollment of first mid-stage clinical GERD trial
(Thomson Reuters ONE) - Corporate news announcement processed and transmitted by Hugin AS.The issuer is solely responsible for the content of this announcement. ------------------------------------------------------------------------------------ Geneva, Switzerland, 28 September 2009 - Addex Pharmaceuticals(SWX:ADXN), the allosteric modulation company, announced thecompletion of enrollment in the Phase IIb trial of ADX10059 as amonotherapy in patients with gastroesophageal reflux disease (GERD),the cause of heartburn and other symptoms. ADX10059 is afirst-in-class reflux inhibitor that works by reducing activation ofthe metabotropic glutamate receptor 5 (mGluR5) through negativeallosteric modulation (NAM). This approach may lead to a new class ofdrugs that addresses the causes of GERD rather than just thesymptoms. ADX10059 also is in clinical trials to treat GERD patientswho are partial responders to Proton Pump Inhibitors (PPIs) andseparately, as a migraine prophylaxis in patients with frequentmigraines.Chief Medical Officer Charlotte Keywood said: "We are pleased thatall three Phase IIb trials of ADX10059 are progressing as planned. Weexpect to communicate top-line data from study 204 late this yearbefore presenting more detailed data at a scientific conference nextyear."Study ADX10059-204 is a double-blind, placebo-controlled,multi-center European Phase IIb trial in 90 GERD patients known torespond well to proton pump inhibitors (PPIs). There is a two weekbaseline symptom evaluation period followed by two weeks ofadministration of ADX10059 120 mg twice daily. ADX10059 is used as amonotherapy so patients in the study do not use PPIs or other acidsuppressant therapy during the baseline and study treatment periods.The co-primary endpoints are patient reported symptom controlcompared to baseline and the effects of ADX10059 on lower esophagealsphincter (LES) function. Objective measures of the effects ofADX10059 on LES function and acid reflux events will be made in asubset of patients using esophageal manometry and pH impedancemonitoring. Data are expected to be communicated in late 2009.Study ADX10059-205 is a double-blind, placebo-controlled,multi-center U.S. and European Phase IIb trial in 280 GERD patientswho are partial responders to PPIs. In Study 205 ADX10059 is beingused as an add-on therapy to the patients' existing PPI treatment.There will be a baseline symptom evaluation period followed by fourweeks of administration of twice-daily ADX10059 (50mg, 100mg or150mg). The primary endpoint is patient reported symptom controlcompared to baseline. Enrollment is expected to complete in thefourth quarter and data will be communicated in early 2010 or late2009.Study ADX10059-206 is a double-blind, placebo-controlled, dose rangefinding, multi-center European Phase IIb trial in 240 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 at the end of the first quarter of 2010.GERD is a chronic condition caused by stomach contents flowing backinto the esophagus on a regular basis. The underlying cause of thisis an abnormally functioning lower esophageal sphincter (LES) musclethat allows stomach contents to pass too easily back into theesophagus. GERD leads to painful symptoms like heartburn and can alsodamage the lining of the esophagus. It is a common disorder withprevalence at about 15% in the United States and between 10% and 25%in Marketed GERD products work by reducing the acidity of the stomachcontents but do nothing to reduce reflux events, so that in manypatients symptoms of GERD persist.mGluR5 inhibition in GERD, inhibition of mGluR5 aims to restorenormal function of the LES muscle thereby preventing reflux andaddressing the cause of the disease. Indeed, ADX10059 has been shownby Addex to reduce reflux and reduce esophageal acid exposure in twoseparate clinical trials(1,2). Research has shown that mGluR5inhibition improves LES function in animals. Reflux inhibitors arebeing recognized as potentially the next generation of GERD therapybecause they address the cause of the disease and are complementaryto marketed acid suppression therapies. Inhibition of mGluR5 hastherapeutic potential in multiple other indications because, as withother glutamate receptors, mGluR5 is involved in a variety offunctions in the central and peripheral nervous systems(3). Inaddition to GERD, mGluR5 inhibitors have achieved clinical proof ofconcept in separate studies in patients with migraine headache(4),Parkinson's disease levodopa induced dyskinesia (PD-LID) andgeneralized anxiety disorder (GAD). Inhibition of mGluR5 also haspotential in Fragile X syndrome, neuropathic pain and depression.(1) Keywood, C., et al., GUT online May 20, 2009 (free download:http://bit.ly/2Rcu0k)(2) Zerbib, F., et al., Digestive Disease Week (DDW) 2009 (freedownload: http://bit.ly/HjehE)(3) Gasparini, F. et al., Current Opinion in Drug Discovery &Development 2008 11(5):655-665(4) Goadsby, P. et al., American Academy of Neurology (AAN) 2009(free download: http://bit.ly/13aBkw)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.Addex 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.comDisclaimerThe foregoing release contains forward-looking statements that can beidentified 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, and involve known and unknown risks,uncertainties and other factors that may cause actual results withallosteric modulators of mGluR4, mGluR2, mGluR5 or other therapeutictargets to be materially different from any future results,performance or achievements expressed or implied by such statements.There can be no guarantee that allosteric modulators of mGluR4,mGluR2 or mGluR5 will be approved for sale in any market or by anyregulatory authority. Nor can there be any guarantee that allostericmodulators of mGluR4, mGluR2, mGluR5 or other therapeutic targetswill achieve any particular levels of revenue (if any) in the future.In particular, management's expectations regarding allostericmodulators of mGluR4, mGluR2, mGluR5 or other therapeutic targetscould be affected by, among other things, unexpected actions by ourpartners, unexpected regulatory actions or delays or governmentregulation generally; unexpected clinical trial results, includingunexpected new clinical data and unexpected additional analysis ofexisting clinical data; competition in general; government, industryand general public pricing pressures; the company's ability to obtainor maintain 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 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.http://hugin.info/138017/R/1343846/322023.pdfhttp://hugin.info/138017/R/1343846/322024.pdfhttp://hugin.info/138017/R/1343846/322026.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: 28.09.2009 - 07:01 Uhr
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