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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New York, NY and Geneva, Switzerland, 19 March 2013 - Addex Therapeutics (SIX: ADXN), a leading company pioneering allosteric modulation-based drug discovery and development, and The Michael J. Fox Foundation for Parkinson's Research announced today that the Foundation awarded a $1,000,000 grant to Addex to help fund continued human clinical testing of dipraglurant for the treatment of Parkinson's disease levodopa-induced dyskinesia (PD-LID). One-third of people with PD develop dyskinesia within four to six years of beginning levodopa treatment; this increases to approximately 90 percent after nine or more years. Patients with Parkinson's disease (PD) can live 10-20 years after diagnosis; however, PD-LID is a leading cause of disability in this growing patient population.

"Dyskinesia is a top priority for our Foundation because of its significant negative impact on patients' quality of life," said Todd Sherer, Ph.D., Chief Executive Officer of The Michael J. Fox Foundation. "Candidates such as dipraglurant and other innovative therapies in development offer the possibility of improved quality of life through better symptomatic treatment of Parkinson's. Dipraglurant targets a molecular mechanism that our Foundation has been investing in since 2005 and we are pleased to take part in its continued progress to the clinic. We are enthusiastic about funding this work and hopeful that it may offer patients relief from a longstanding issue with the treatment of their disease."

Dyskinesias are the uncontrollable and disruptive movements that are caused by long-term use of levodopa (Sinemet), a dopamine replacement therapy and the gold-standard treatment for Parkinson's disease. There is no FDA-approved treatment for dyskinesia. Existing treatment options are limited and insufficient to address patients' medical needs. Patients are faced with a lose-lose situation: Take as much levodopa as needed to manage symptoms, and cope with dyskinesia; or take less medicine in an effort to delay or prevent dyskinesia, and cope with symptoms. The Michael J. Fox Foundation has invested more than $26 million in dyskinesia-targeted research to date, including support for a successful Phase 2a trial of dipraglurant completed by Addex in 2012.

"We are extremely pleased to receive this grant from The Michael J. Fox Foundation supporting the further development of dipraglurant," said Bharatt Chowrira, Ph.D., Chief Executive Officer of Addex Therapeutics. "We believe the successful completion of the Phase 2a study offers some promise that dipraglurant has the potential to significantly change both the way patients are treated as well as their quality of life.  The work we will be able to pursue with this grant is critical to our continued advancement of this important approach to the treatment of PD-LID. Ultimately, we hope to see dipraglurant become the first drug to alleviate all PD-LID symptoms."

Dipraglurant is an oral, small molecule allosteric modulator that inhibits selectively the metabotropic glutamate receptor 5 (mGluR5), a Class C G-Protein Coupled Receptor (GPCR). Dipraglurant holds potential to be used in combination with levodopa or dopamine agonists, or as a standalone treatment for PD-LID, PD-related motor symptoms, dystonia, non-motor symptoms of PD and other movement disorders. Data from a Phase 2a showed that dipraglurant met the primary objective of the study by exhibiting a good safety and tolerability profile. Dipraglurant also demonstrated a statistically significant reduction in LID severity with both 50 and 100 mg doses. Dipraglurant appears to reduce dystonia severity in addition to chorea, the two major LID components. In a double-blind, placebo-controlled study conducted in the US and Europe, the primary objective was to demonstrate safety and tolerability in PD-LID patients. In addition, the trial was designed to evaluate exploratory efficacy as a secondary objective. Efficacy was measured using the modified Abnormal Involuntary Movement Scale (mAIMS), patient diaries documenting "off-time" (impaired voluntary movement), "on-time" (with or without dyskinesia) and sleep. The trial was supported by a grant from The Michael J. Fox Foundation for Parkinson's Research.

About The Michael J. Fox Foundation for Parkinson's Research

As the world's largest private funder of Parkinson's research, The Michael J. Fox Foundation is dedicated to accelerating a cure for Parkinson's disease and improved therapies for those living with the condition today. The Foundation pursues its goals through an aggressively funded, highly targeted research program coupled with active global engagement of scientists, Parkinson's patients, business leaders, clinical trial participants, donors and volunteers.  In addition to funding more than $300 million in research to date, the Foundation has fundamentally altered the trajectory of progress toward a cure. Operating at the hub of worldwide Parkinson's research, the Foundation forges groundbreaking collaborations with industry leaders, academic scientists and government research funders; increases the flow of participants into Parkinson's disease clinical trials with its online tool, Fox Trial Finder; promotes Parkinson's awareness through high-profile advocacy, events and outreach; and coordinates the grassroots involvement of thousands of Team Fox members around the world.

For more information, visit us at:
Web site: michaeljfox.org 
Facebook: facebook.com/michaeljfoxfoundation 
LinkedIn: bit.ly/mjffPDOR 
Twitter: @MichaelJFoxOrg
 

About Addex Therapeutics

Addex Therapeutics (www.addextherapeutics.com) is a development stage company focused on advancing innovative oral small molecules against rare diseases utilizing its pioneering allosteric modulation-based drug discovery platform. The Company's two lead products are being investigated in Phase 2 clinical testing: dipraglurant (dipraglurant, an mGlu5 negative allosteric modulator or NAM) is being developed by Addex to treat Parkinson's disease levodopa-induced dyskinesia (PD-LID) and rare forms of dystonia; and ADX71149 (mGlu2 positive allosteric modulator or PAM) is being developed in collaboration with Janssen Pharmaceuticals, Inc. to treat both schizophrenia and anxiety as seen in patients suffering from major depressive disorder. Addex is also advancing several preclinical programs including: GABA-BR positive allosteric modulator (PAM) for Charcot-Marie-Tooth (type 1a) disease, spasticity in patients with multiple sclerosis (MS), pain, overactive bladder and other disorders; and mGlu4 PAM for MS, Parkinson's disease, anxiety and other diseases. 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. The Company uses its proprietary discovery platform to target receptors and other proteins that are recognized as essential for the therapeutic modulation of important diseases with unmet medical needs.

Tim Dyer
Chief Financial Officer
Addex Therapeutics
+41 22 884 15 61
PR(at)addextherapeutics.com

Disclaimer: The foregoing release may contain forward-looking statements that can 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 regarding Addex Therapeutics, formerly known as, Addex Pharmaceuticals, its business, the potential approval of its products by regulatory authorities, or regarding potential future revenues from such products. Such forward-looking statements reflect the current views of Addex Therapeutics regarding future events, future economic performance or prospects, and, by their very nature, involve inherent risks and uncertainties, both general and specific, whether known or unknown, and/or any other factor that may materially differ from the plans, objectives, expectations, estimates and intentions expressed or implied in such forward-looking statements. Such may in particular cause actual results with allosteric modulators of mGlu2, mGlu4, mGlu5, GABA-BR or other therapeutic targets 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 mGlu2, mGlu4, mGlu5, GABA-BR or other therapeutics targets will be approved for sale in any market or by any regulatory authority. Nor can there be any guarantee that allosteric modulators of mGlu2, mGlu4, mGlu5, GABA-BR or other therapeutic targets will achieve any particular levels of revenue (if any) in the future. In particular, management's expectations regarding allosteric modulators of mGlu2, mGlu4, mGlu5, GABA-BR or other therapeutic targets could be affected by, among other things, unexpected actions by our partners, unexpected regulatory actions or delays or government regulation generally; unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; competition in general; government, industry and general public pricing pressures; the company's ability to obtain or maintain patent or other proprietary intellectual property protection. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Addex Therapeutics is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise, except as may be required by applicable laws.