Addex Therapeutics Announces Presentation of Dipraglurant Phase 2a Study Results at the 2013 Annual Meeting of the American Academy of Neurology (AAN)
$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 (SIX: ADXN), a leading company pioneering allosteric modulation-based drug discovery and development announced today that François 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.
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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.