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Addex ADX71441 Preclinical Results for Treatment of Alcohol Use Disorder Published in Journal of Psychopharmacology

 

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.

Contact:
Tim Dyer
Chief Executive Officer
Addex Therapeutics
Telephone: +41 22 884 15 61
Email: PR(at)addextherapeutics.com

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.

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Addex ADX71441 Preclinical Results for Treatment of Alcohol Use Disorder Published in Journal of Psychopharmacology

 

Study Conducted in Collaboration with National Institute on Alcohol Abuse and Alcoholism

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Addex Awarded $835,000 Grant from Michael J. Fox Foundation to Advance TrkB PAMs for the Treatment of Parkinson’s Disease


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Addex Therapeutics Reports First Half 2016 Operating Highlights and Financial Results

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Addex Collaborators Published New Data Supporting the Role of Negative Allosteric Modulators of Follicle Stimulating Hormone and Luteinizing Hormone Receptors in Reproductive Health

 

Geneva, Switzerland, 20 September 2016 – Addex Therapeutics (SIX: ADXN) announced today the publication of new scientific...

Addex ADX71441 Demonstrates Positive Results in Highly Translational Preclinical Model of Spasticity.


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LifeSci Capital Issues Equity Research Report on Addex Therapeutics

 

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Van Leeuwenhoeck Issues Research Note on Addex Therapeutics


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Addex Dipraglurant Positive Phase 2 Data in PD-LID Published in Leading Peer Reviewed Journal of the Movement Disorder Society


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Addex Therapeutics Reports 2015 Financial Results

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Additional analysis underlines the potential significant therapeutic benefit of dipraglurant to patients with Parkinson’s disease....

Addex’ Dipraglurant Receives Orphan Drug Designation from the FDA for Levodopa-Induced Dyskinesia Associated with Parkinson’s Disease


FDA Orphan Drug Status Validates the Potential Therapeutic Use of Dipraglurant in this Rare Disease

Geneva,...

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ValuationLAB Issues Research Report on Addex Therapeutics with Share Price Estimate of CHF5.2 per Share


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Addex’ ADX71441 Demonstrates Robust Efficacy in Multiple Preclinical Models of Alcohol Use Disorder


Successful collaboration with the US National Institute for Alcohol Abuse and Alcoholism

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Addex Therapeutics Reports First Half 2015 Financial Results

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Addex ADX71149 Demonstrates Synergistic Efficacy with Levetiracetam in Preclinical Models of Epilepsy


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Pierre Fabre Pharmaceuticals and Addex Therapeutics Sign Early-Stage Agreement in the Central Nervous System (CNS) Field


  • Addex Grants Option to License mGlu3 Receptor Program to Pierre Fabre Pharmaceuticals
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Alpha Deal Group Initiates Independent Research Coverage on Addex Therapeutics


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Addex Dipraglurant Demonstrates Anxiolytic- and Antidepressant-like Activity in Multiple Preclinical Models Relevant for Non-Motor Symptoms in Parkinson’s Disease

 

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Addex Dipraglurant Dosed in First Subject in Receptor Occupancy Study in Collaboration with Johns Hopkins University and with Funding from The Michael J. Fox Foundation

 

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Addex Shareholders Appoint Raymond Hill and Tim Dyer to the Board of Directors and approve all Board Proposals at Annual General Meeting

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Addex Identifies New Potential Use of mGlu7 receptor NAMs to Treat Stress-Induced Visceral Pain

 

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Addex and Prof. Pisani Present Dipraglurant data in Rare Inherited Forms of Dystonia

 

5th Biennial Workshop on Dystonia “Controversies in Dystonia and Parkinsonism” Rome, 29-30 May 2015

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Addex Enters Collaboration with Prof. Pisani to Explore the Therapeutic use of Dipraglurant in the Treatment of Rare Inherited Forms of Dystonia

 

Geneva, Switzerland 7 May 2015 – Addex Therapeutics (SIX: ADXN), a leading company pioneering allosteric modulation-based drug discovery and development announced today entering a...

Addex Raises CHF2.8 million in a Private Placement and Extends Cash Runway Through 2017

 

Geneva, Switzerland, 9 March 2015 – Addex Therapeutics (SIX: ADXN) announced today that it has raised gross proceeds of CHF2.8 million in a private placement of new issued registered...

Addex Initiates Dipraglurant Receptor Occupancy Clinical Study in Collaboration with Johns Hopkins University with Funding from The Michael J. Fox Foundation

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Addex Completes 2014 with Strong Cash Position and Provides 2015 Strategic Update

 

Geneva, Switzerland, 9 January 2015 – Addex Therapeutics (SIX: ADXN), a leading company pioneering allosteric modulation-based drug discovery and development announced today:

Financial Update<br...

Addex and NIAAA Enter Collaboration to Evaluate ADX71441 in Alcohol Use Disorder


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Addex Amends mGlu2PAM Collaboration Agreement and Receives USD757,000

 

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Addex and the Charcot-Marie-Tooth Association enter collaboration to advance ADX71441 in Charcot-Marie-Tooth 1A disorder

 

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Addex ADX71441 Positive Results in Preclinical Model of Nicotine Addiction


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Addex Shareholders Approve All Board Proposals at Annual General Meeting

 

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Addex Therapeutics Publishes Annual Report 2013

 

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Addex Therapeutics Reports 2013 Financial Results

 

2013 Financial Highlights

  • Significant reduction in 2013 cash utilization of CHF12.3 million, significantly below guidance of CHF15 million, CHF1.6 million used in second half of 2013...

Addex Reports Top-line Data from ADX71149 Phase 2a Study in Patients with Major Depressive Disorder (MDD) with Significant Anxiety Symptoms

 

Geneva, Switzerland, 7 February 2014 - (SIX:ADXN), Addex Therapeutics, a leading company pioneering allosteric modulation-based drug discovery and development, announced today top-line data from a Phase 2a...

Addex and NIDA enter collaboration to advance ADX71441 & ADX88178 in drug abuse and addiction

 

Geneva, Switzerland, 4 November 2013 – Addex Therapeutics (SIX: ADXN), a leading company pioneering allosteric modulation-based drug discovery and development announced today entering a collaboration with the...

Addex Licensee Completes Enrolment of 120 Patients in a Phase 2 Clinical Trial of ADX71149 for the Treatment of Anxious Depression

On track to report top line results end of Q1 2014

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Addex ADX71441 Dose Dependently Reduced PMP22 Expression Comparable to Baclofen in a Pre-Clinical Transgenic Model of Charcot-Marie-Tooth 1A Disease

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Addex Therapeutics First Half 2013 Financial Results

 

Geneva, Switzerland, 17 September 2013 - Addex Therapeutics (SIX: ADXN), a leading company pioneering allosteric modulation-based drug discovery and development announced today its first...

Chronic treatment with Addex Dipraglurant Rescues Impairment of Long-Term Synaptic Plasticity in a Validated Preclinical Model of Primary Generalized Torsion Dystonia 1

 

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Addex Therapeutics raises CHF3.2 million in a Private Placement to International Institutional Investors

Cash runway extended to end of 2014

Geneva, Switzerland, 9 August 2013 – Addex Therapeutics (SIX: ADXN) announced today that it has raised gross proceeds of CHF3.2 million (US$3.5 million) in a private placement...

Addex Completes Restructuring to Focus on Capturing Potential Upside from its Partnered Asset and CEO Steps Down

                             
Geneva, Switzerland, 31 May...

Addex Announces Steps to Capture Potential Upside from its Partnered Asset and Preserve Value for Shareholders


Company intends to restructure the organization and monetize its pipeline and platform assets

Geneva, Switzerland, 28 May 2013 – Addex Therapeutics (SIX: ADXN), announced today that it...

Addex Validates Potential Efficacy Biomarker for Phase 1 Trial of its GABA-B Positive Allosteric modulator, ADX71441

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Addex Reports that Dipragluant Demonstrated Dose-Dependent mGlu5 Receptor Occupancy in a Non-Human Primate PET Study

 

• Dose-dependent receptor occupancy correlates with plasma exposure and links to efficacy in non-human primate model of Parkinson’s Disease levodopa-induced dyskinesia
• Data reinforces Phase 2a pharmacological...

Addex Announces CFO, Tim Dyer, to Transition to External Consulting Role

 

Geneva, Switzerland, 30 April 2013 – Addex Therapeutics (SIX:ADXN), a leading company pioneering allosteric modulation-based drug discovery and development, announced that Tim Dyer, Co-Founder and Chief...

Addex Reports ADX71441 Reduces Alcohol Intake in a Preclinical Model of Chronic Alcohol Dependence


• Data reinforces broad therapeutic potential of ADX71441, an oral GABAB receptor Positive Allosteric Modulator
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Addex Receives Approval to Initiate a Phase 1, First–In-Man, Clinical Study for ADX71441


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Addex Announces Issuance of a Broad European Composition of Matter Patent for Dipraglurant

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Addex Dipraglurant Normalizes Striatal Cholinergic Dysfunction in a Validated Preclinical Model of Primary Generalized Torsion Dystonia 1 (DYT1)

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Addex Therapeutics Announces Presentation of Dipraglurant Phase 2a Study Results at the 2013 Annual Meeting of the American Academy of Neurology (AAN)

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Geneva,...

Addex Shareholders Approve All Board Proposals at Annual General Meeting

Geneva, Switzerland, 20 March 2013 – Addex Therapeutics (SIX: ADXN), a leading company pioneering allosteric modulation-based drug discovery and development, announced today that its...

Addex Therapeutics Awarded $1 MM Grant from The Michael J. Fox Foundation for Parkinson's Research

Grant to be used to help fund further human clinical testing of dipraglurant for the treatment of Parkinson's disease levodopa-induced dyskinesia

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Addex Partners with Viva Biotech to Advance Allosteric Modulators Targeting Adenosine 2A Receptor

Partnership to demonstrate the potential to accelerate the development of allosteric modulator-based therapeutics against GPCRs by integrating proprietary functional and structural biology...

Addex to Focus Resources on Clinical Pipeline

 

2013 Value Drivers:

• Initiate Phase 2 clinical testing of dipraglurant (mGlu5 NAM) in a rare disease indication
• Submit Orphan Drug Application in U.S. and Europe for dipraglurant<br...

Addex Dipraglurant Reduces Motor Abnormalities in a Preclinical Model Relevant for Several Rare types of Dystonia


Dipraglurant, a novel oral small molecule negative allosteric modulator of mGlu5 receptor, on track for Phase 2 clinical testing in the second half of 2013

 

Addex Announces Issuance of a Broad US Composition of Matter Patent for ADX71441

ADX71441, a novel oral small molecule positive allosteric modulator of GABA-B receptor, on track for Phase 1 clinical testing in the first half of 2013

Allostery: Key to addressing important unmet needs in CNS diseases

Addex'high throughput allosteric drug discovery platform is paving the way for a new approach to cracking "undruggable" therapeutic targets.

Addex Reports ADX71441 Reduces Alcohol Intake in a Preclinical Model of Alcohol Binge Drinking

- Data reinforces broad therapeutic potential of oral ADX71441 

-

Dyskinesia: Hope on the Horizon

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Addex and Collaborators Awarded Swiss CTI Grant to Develop Allosteric Modulators for Neurodegenerative and Psychiatric Diseases


Grant to Further Characterize Allosteric Modulators Against mGluR4 and mGluR7
Geneva, Switzerland, 2 October 2012

Addex...

Addex mGluR4 Allosteric Modulator Effective in Multiple Sclerosis Model

A Novel Oral Small Molecule Approach for the Treatment of Multiple Sclerosis
Geneva, Switzerland, 24 September 2012 – Addex Therapeutics (SIX:ADXN), a leading company pioneering...

Soutien américain au biotech à Genève

ADDEX.Le titre a bénéficié d'un regain d'intérêt des investisseurs outre-Atlantique.
La direction plaide encore la sous-évalutation.

Addex Partner Doses First Patient in Phase 2 Clinical Study of ADX71149 for the Treatment of Major Depressive Disorder Patients with Anxiety Symptoms

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Addex Therapeutics First Half 2012 Financial results

Geneva, Switzerland, 22 August 2012 – Addex Therapeutics...

Positive Early Results for Addex Parkinson's Drug Dipraglurant Spur Hopes for Deal


In a small, short Phase IIa study, an oral inhibitor of mGluR5 proved effective at reducing dyskinesia caused by levodopa.

Addex Announces the Publication of Positive Data on the Efficacy of mGluR4 Positive Allosteric Modulator in Parkinson’s Disease Pre-Clinical Models


- Seminal Research Provides Greater Insight into the Role of Selective mGluR4 Modulation on Motor Symptoms