News Article | May 4, 2017
Study Conducted in Collaboration with National Institute on Alcohol Abuse and Alcoholism Geneva, Switzerland, 4 May 2017 - Addex Therapeutics (SIX: ADXN) announced today that the results of a preclinical study evaluating ADX71441 in animal models of alcohol use disorder were published in the Journal of Psychopharmacology. The study was led by Prof. Markus Heilig of Linköping University, Sweden, and was conducted in collaboration with the National Institute on Alcohol Abuse and Alcoholism (NIAAA), a division of National Institutes of Health. The results of the study demonstrated that ADX71441, a positive allosteric modulator (PAM) of the gamma-aminobutyric acid subtype B (GABAB) receptor, dose-dependently suppressed alcohol self-administration of both dependent and non-dependent animals, but its potency was higher in alcohol-dependent rats. This effect was robust, appearing at a dose of 3 mg/kg in non-dependent animals, and reached a >80% reduction of self-administration at a dose of 10 mg/kg; the dose of 1 mg/kg was sufficient in animals with a history of dependence. Furthermore, both cue- and stress-induced alcohol seeking were blocked by ADX71441. Suppression of responding for alcohol was not the result of non-specific sedative or otherwise performance-impairing properties of the drug, as ADX71441 did not impair locomotor activity at doses between 1 and 10 mg/kg. ADX71441 displayed a 10-fold separation between specific behavioral effects and sedation. The data indicated that ADX71441 may be beneficial in treating alcohol use disorder in humans, as it retains the efficacy of the GABAB receptor agonist, baclofen, while potentially having a better therapeutic index. The results also indicated that maximal efficacy of ADX71441 can be expected in severely dependent patients. Finally, the data provided a basis for developing a functional magnetic resonance imaging(fMRI) based translational biomarker that could advance clinical development of ADX71441 in alcohol use disorder more rapidly and reliably. "These data are very encouraging and strongly support the further development of ADX71441 in alcohol use disorder." said Prof. Markus Heilig of Department of Clinical and Experimental Medicine, Linköping University "GABA B activation is a well validated target for alcohol use disorder through the work performed with baclofen and we look forward to studying ADX71441 in patients." "The publication of Prof Heilig's research in this prestigious scientific journal further validates the development of ADX71441 in alcohol use disorder," said Sonia Poli, CSO of Addex. "We look forward to leveraging the results of this study in our clinical development plan for ADX71441. We expect to initiate a Phase I study for ADX71441 as a potential treatment for alcohol and cocaine addiction in the third quarter of this year." "We thank the NIAAA for their support and Prof. Heilig and his team for their work accomplished with ADX71441 in this study," commented Tim Dyer, CEO of Addex. "These new data are indicative of how we are informing our clinical development programs through collaborations with leading academic institutions." Publication Details Augier et al.: "The GABAB positive allosteric modulator, ADX71441 attenuates alcohol self-administration and relapse to alcohol seeking in rats", Neuropsychopharmacology, 2017, Mar 15 - Epub ahead of print About GABA B receptor The GABAB receptor is clinically & commercially validated. Generic GABAB receptor agonist, baclofen, is marketed for spasticity and some spinal cord injuries, and French health authorities have approved its use for the treatment of alcoholism. Baclofen is also used off label for a number of other indications including overactive bladder (OAB), but its utility is limited due to variety of side effects and rapid clearance, requiring frequent administration of higher doses. About ADX71441 ADX71441 is a potent selective positive allosteric modulator (PAM) which potentiates GABA responses at the GABAB receptor. ADX71441 is a novel, first-in-class, oral, small molecule that demonstrated excellent preclinical efficacy and tolerability in rodent models of pain, anxiety, OAB, alcohol use disorders, nicotine dependence and in a non-human primate model of cocaine use disorder. ADX71441 has also proven efficacy in a genetic model of Charcot-Marie-Tooth Type 1A disease (CMT1A). ADX71441 has a different molecular mechanism from the generic drug baclofen in that it is a positive allosteric modulator, rather than an orthosteric agonist at the GABAB receptor, with a longer half-life, suitable for once daily administration. ADX71441 only acts when the natural ligand (GABA) activates the receptor, therefore respecting the physiological cycle of activation. It has been proposed that PAMs produce less adverse effects and lead to less tolerance than direct agonists. Addex Therapeutics (www.addextherapeutics.com) is a biopharmaceutical company focused on the development of novel, orally available, small molecule allosteric modulators for neurological disorders. Allosteric modulators are an emerging class of small molecule drugs which have the potential to be more specific and confer significant therapeutic advantages over conventional "orthosteric" small molecule or biological drugs. Addex's allosteric modulator drug discovery platform targets receptors and other proteins that are recognized as essential for therapeutic intervention - the Addex pipeline was generated from this pioneering allosteric modulator drug discovery platform. Addex's lead drug candidate, dipraglurant (mGluR5 negative allosteric modulator or NAM) has successfully completed a Phase 2a POC in Parkinson's disease levodopa-induced dyskinesia (PD-LID), and is being prepared to enter registration trials for PD-LID with support from the Michael J. Fox Foundation for Parkinson's Research (MJFF). In parallel, dipraglurant's therapeutic use in dystonia is being investigated with support from the Dystonia Medical Research Foundation (DMRF). Addex's second clinical program, ADX71149 (mGluR2 positive allosteric modulator or PAM) is being developed in collaboration with Janssen Pharmaceuticals, Inc for epilepsy. In addition, ADX71441 (GABAB receptor PAM) has received regulatory approval to start Phase 1 and is being investigated for its therapeutic use in Charcot-Marie-Tooth Type 1A disease (CMT1A), cocaine and alcohol use disorder and nicotine dependence. Discovery programs include mGluR4PAM, mGluR7NAM, TrkBPAM and mGluR3NAM & PAM. Disclaimer / Forward-looking statements: This communication does not constitute an offer or invitation to subscribe for or purchase any securities of Addex Therapeutics Ltd. This publication may contain certain forward-looking statements concerning the Company and its business. Such statements involve certain risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of the Company to be materially different from those expressed or implied by such statements. Readers should therefore not place undue reliance on these statements, particularly not in connection with any contract or investment decision. The Company disclaims any obligation to update these forward-looking statements.
News Article | April 21, 2017
— Neurodegenerative Disorders Drug Development Pipeline Review, 2017 market report says Small molecule drugs dominate the pipeline, with approximately 64% of total pipeline molecules. In comparison, the number of biologics in the pipeline is much lower, representing approximately 26% of the pipeline. Overall the neurodegenerative disorders pipeline is large, with a substantial proportion of products being early-stage assets at the Preclinical development stage. Browse the 200 Tables and Figures, Spread across 797 Pages Report Available at http://www.reportsnreports.com/contacts/discount.aspx?name=964827. There are over 1,400 products in active development in the neurodegenerative disorders therapy area. The current market landscape consists of a number of biologics and small molecules, while the pipeline also consists of gene therapies and cell therapies, demonstrating broader pharmaceutical research and development. The report provides comprehensive information on the pipeline development landscape for is Alzheimer’s disease, Parkinson’s disease, Huntington’s disease, Amyotrophic lateral sclerosis and Multiple sclerosis, from Discovery through to the Pre-registration stage. This includes an analysis of products by stage of development, molecular target, mechanism of action (MoA), route of administration (RoA) and molecule type. Finally, the report provides an overview of key players involved in the development of products in this area, and outlines recent updates and press releases in the field. Scope of The Report • Which companies are the most active within the pipeline for neurodegenerative disorders? • Which pharmaceutical approaches are the most prominent at each stage of the pipeline and within each indication? • To what extent do universities and institutions play a role within this pipeline, compared to pharmaceutical companies? • What are the most important R&D milestones and data publications to have happened in this disease area? Alzheimer's Disease – Pipeline for AB Science SA, AbbVie Inc, AC Immune SA, Accera, Inc., Acelot, Inc., Actinogen Limited, Acumen Pharmaceuticals, Inc., Addex Therapeutics Ltd, Affibody AB, AFFiRiS AG, Alector LLC, Alkermes Plc, Allergan Plc, Allinky Biopharma, ALSP, Inc., Alzhyme Pty Ltd, Alzinova AB, AlzProtect SAS, Amarantus Bioscience Holdings, Inc., Amgen Inc., Anavex Life Sciences Corp., Aphios Corporation, Apodemus AB, Applied Research using OMIC Sciences, S.L., Araclon Biotech, S.L., Archer Pharmaceuticals, Inc., ArmaGen Inc., Artery Therapeutics, Inc., AskAt Inc., Astellas Pharma Inc., AstraZeneca Plc, Asubio Pharma Co., Ltd., Ausio Pharmaceuticals, LLC, Avineuro Pharmaceuticals, Inc., Axon Neuroscience SE, Axovant Sciences Ltd., Axsome Therapeutics, Inc., Axxam SpA, Beactica AB, Berg LLC, BioArctic Neuroscience AB, Bioasis Technologies Inc., Biogen Inc, Biomar Microbial Technologies, Bionature E.A. Ltd., Boehringer Ingelheim GmbH, Bristol-Myers Squibb Company, Bsim2, Cardax Pharmaceuticals, Inc., Carna Biosciences, Inc., Celon Pharma Sp. z o.o., CHA Bio & Diostech Co., Ltd., Chase Pharmaceuticals Corporation, Clera Inc., Cognition Therapeutics, Inc., Cognosci, Inc., CohBar, Inc., Connexios Life Sciences Pvt. Ltd., ContraVir Pharmaceuticals, Inc., Corium International, Inc., Coronis Partners Ltd., Cortice Biosciences, Inc., Critical Outcome Technologies Inc., Crossbeta Biosciences B.V., D-Pharm Ltd., Daewoong Pharmaceutical Co., Ltd., Daiichi Sankyo Company, Limited, Daval International Limited, DermaXon, LLC, Dongkook Pharmaceutical Co., Ltd., Eisai Co., Ltd., Eli Lilly and Company, Emergent BioSolutions Inc., EncephRx, Inc., Endece, LLC, ENKAM Pharmaceuticals A/S, Ensemble Therapeutics Corporation, Ensol Biosciences Inc., Epigen Biosciences, Inc., Euroscreen S.A., Evotec AG, F. Hoffmann-La Roche Ltd., FORUM Pharmaceuticals Inc., Genentech, Inc., Genervon Biopharmaceuticals, LLC, GlaxoSmithKline Plc, GliaCure Inc., Glialogix, Inc., Golden Biotechnology Corp., Grifols, S.A., H. Lundbeck A/S, Heptares Therapeutics Limited, HitGen LTD, Humanetics Corporation, Ichor Medical Systems, Inc., Icure Pharmaceutical Inc., Immungenetics AG, Impel NeuroPharma, Inc., ImStar Therapeutics Inc., Inovio Pharmaceuticals, Inc., IntelGenx Corp., Intellect Neurosciences, Inc., Intra-Cellular Therapies, Inc., INVENT Pharmaceuticals, Inc., Io Therapeutics, Inc., Iproteos S.L., Jeil Pharmaceutical Co. Ltd., Jiangsu Kanion Pharmaceutical Co.Ltd., Johnson & Johnson, K-Stemcell Co.Ltd., Kadmon Corporation, LLC, Kalgene Pharmaceuticals Inc., Kareus Therapeutics, SA, KineMed, Inc., Krenitsky Pharmaceuticals Inc., Kyowa Hakko Kirin Co.Ltd., Lead Discovery Center GmbH, Les Laboratoires Servier SAS, Lipopharma Therapeutics SL, Living Cell Technologies Limited, Lupin Limited, M3 Biotechnology, Inc., ManRos Therapeutics, MedDay SA, Medestea Research & Production S.p.A., MedImmune, LLC, Medisyn Technologies, Inc., MEDRx Co.Ltd., Merck & Co.Inc., Metabolic Solutions Development Company, LLC Place Order to This Report at http://www.reportsnreports.com/purchase.aspx?name=964827. List of Tables Number of Products under Development for Alzheimer's Disease 28 Number of Products under Development for Alzheimer's Disease – Comparative Analysis 29 Comparative Analysis by Late Stage Development, Alzheimer's Disease 85 Comparative Analysis by Clinical Stage Development, Alzheimer's Disease 86 Alzheimer's Disease – Pipeline by AB Science SA, 158 Alzheimer's Disease – Pipeline by AbbVie Inc, 159 List of Figures Number of Products under Development for Alzheimer's Disease 28 Number of Products under Development for Alzheimer's Disease – Comparative Analysis 29 Comparative Analysis by Late Stage Development, Alzheimer's Disease 85 Comparative Analysis by Clinical Stage Development, Alzheimer's Disease 86 Number of Products by Top 10 Mechanism of Actions, Alzheimer's Disease 556 Assessment by Monotherapy Products, Amyotrophic Lateral Sclerosis 585 In Depth Table of Content for Neurodegenerative Disorders Drug Development Pipeline Review, 2017 About Us: ReportsnReports.com is your single source for all market research needs. 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