Addex Therapeutics Announces Presentation of Dipraglurant Phase 2a Study Results at the 2013 Annual Meeting of the …

Posted: Published on March 22nd, 2013

This post was added by Dr Simmons

$1 MM grant by The Michael J. Fox Foundation to be used to help fund further human clinical testing of dipraglurant for the treatment of Parkinson`s disease levodopa-induced dyskinesia

Geneva, Switzerland, 21 March 2013 - Addex Therapeutics (ADXN.SW), a leading company pioneering allosteric modulation-based drug discovery and development announced today that Franois Tison, M.D.-Ph.D., Professor at the University of Bordeaux, on behalf of the ADX48621-201 Study Group, presented the positive data obtained from a Phase 2a proof-of-concept trial of dipraglurant (ADX48621) in Parkinson`s patients with levodopa-induced dyskinesia (PD-LID) in an oral presentation at the AAN conference on 20th March 2013. The recent $1,000,000 grant by The Michael J. Fox Foundation for Parkinson`s Research will be used to help fund continued human clinical testing of dipraglurant for the treatment of 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.

"We believe the successful completion of the Phase 2a study showed significant promise that dipraglurant has the potential to change the way these patients are treated as well as their quality of life," said Graham Dixon, Ph.D., Chief Scientific Officer of Addex Therapeutics. "The clinical studies that we plan to complete in the coming months, supported in part by the grant from The Foundation, are critical to our continued advancement of this important approach for the treatment of PD-LID."

Dipraglurant is an oral, small molecule allosteric modulator that inhibits selectively the metabotropic glutamate receptor 5 (mGlu5), a Class C G-Protein Coupled Receptor (GPCR). The Phase 2a trial was a randomised, double-blind, placebo-controlled study in 76 patients with moderate to severe levodopa-induced dyskinesia conducted at 25 sites in Europe and the United States. In the presentation at the AAN conference, Professor Tison reported that the study met the primary objectives of safety and tolerability at both 50 and 100mg doses; supporting further clinical testing in this patient population. In addition, dipraglurant demonstrated positive anti-dyskinetic effect measured by observer evaluated mAIMS, patient reported diary data and patient and clinician global impression of change scales. Further, there was no negative effect on Parkinsonism and the data suggested that dipraglurant provided a beneficial effect on motor fluctuation. Addex has previously reported top-line results from this study last year. The Phase 2a study was supported by a $900,000 grant from The Michael J. Fox Foundation for Parkinson`s Research.

"We continue to be engaged in partnering discussions with a number of global players who we believe have the expertise and capability to fully exploit dipraglurant and expect to have a deal completed sometime this year," said Bharatt Chowrira, Ph.D., Chief Executive Officer of Addex Therapeutic. "While we continue to advance this compound for PD-LID we will also initiate parallel clinical efforts for a rare form of dystonia. We expect to initiate a Phase 2 study in dystonia and report data by the end of 2013. Completion of the PD-LID clinical work as well as the dystonia study will bring significant value to our dipraglurant franchise."

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 61PR@addextherapeutics.com

The owner of this announcement warrants that: (i) the releases contained herein are protected by copyright and other applicable laws; and (ii) they are solely responsible for the content, accuracy and originality of the information contained therein.

Source: Addex Therapeutics via Thomson Reuters ONE HUG#1687224

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Addex Therapeutics Announces Presentation of Dipraglurant Phase 2a Study Results at the 2013 Annual Meeting of the ...

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