GENEVA, SWITZERLAND--(Marketwire - September 07, 2010) - Addex Pharmaceuticals / Addex Awarded Michael J. Fox Foundation Grant for ADX48621 to treat Levodopa-Induced Dyskinesia in Parkinson’s Disease processed and transmitted by Hugin AS. The issuer is solely responsible for the content of this announcement.
Geneva, Switzerland, 8 September 2010 - Allosteric modulation company Addex Pharmaceuticals Ltd (SWISS: ADXN) announced today that it has been awarded a $900,000 grant from The Michael J. Fox Foundation (MJFF) to help fund a Phase II study of ADX48621 for the treatment of Parkinson’s disease levodopa- induced dyskinesia (PD-LID). Patients with PD can live 10-20 years after diagnosis; however, LID is a leading cause of disability in this growing patient population.
“People with Parkinson’s report that the side-effects of levodopa treatment are one of the most difficult aspects of living with the disease. We believe ADX48621 has the potential to improve the quality of life for patients suffering from the undesirable effects of long-term dopamine replacement,” said Katie Hood, CEO, The Michael J. Fox Foundation. “ADX48621 targets a molecular mechanism that our Foundation has been investing in since 2005. We’re enthusiastic about funding this clinical work and the hope that it may bring to patients.”
ADX48621 is a metabotropic glutamate receptor 5 (mGluR5) negative allosteric modulator (NAM). It already has successfully completed Phase I testing in three studies involving a total of 130 patients, including older healthy volunteers. A Phase II study of ADX48621 to treat PD-LID is expected to start in the U.S. and EU during the fourth quarter of 2010.
“We are honored to receive this grant from The Michael J. Fox Foundation supporting ADX48621 development,” said Vincent Mutel, CEO of Addex. “The reduction in both major components of LID, which we observed after administering ADX48621 to non-human primates with LID, has not been reported with other drugs on the market or in development. As a result, we believe that it could become the first drug capable of alleviating all LID symptoms.”
Levodopa and dopamine agonists are effective treatments for the signs and symptoms of Parkinson’s disease; but long-term levodopa use results in the emergence of side effects, especially abnormal involuntary movement, termed levodopa-induced dyskinesia or LID. Statistics show that half of patients develop LID during the first five years of treatment. The two main components of LID are chorea and dystonia. Chorea is manifest as sudden rapid uncontrolled movements. Dystonia is manifest as slow writhing type movements and sustained muscle contractions, which can be painful.
In addition to reducing chorea, the stereotypical trembling often associated with PD patients, ADX48621 is the first drug-candidate to effectively reduce dystonia in the non-human primate “MPTP model” of PD-LID.
mGluR5 inhibition reduces signaling activity of the neurotransmitter glutamate. The loss of dopamine producing cells observed as a result of Parkinson’s disease leads to excess of glutamatergic stimulation in the brain’s striatopallidal pathway. The mGluR5 are found abundantly in the striatum. Because most drugs for PD work via the dopaminergic system, inhibition of mGluR5 could provide a novel and complementary treatment option for PD and PD-LID. Indeed, published research shows that ADX48621 and other mGluR5 inhibitors have reduced LID and generated anti-Parkinsonian effects in animal models of PD-LID and Parkinson’s disease, respectively. In addition, one small clinical study already has shown that mGluR5 inhibition reduced LID symptoms in humans with PD-LID.
The Michael J. Fox Foundation was founded in 2000. The Michael J. Fox Foundation for Parkinson’s Research is dedicated to ensuring the development of a cure for Parkinson’s disease through an aggressively funded research agenda. The Foundation has funded almost $200 million in research to date.
Addex Pharmaceuticals (www.addexpharma.com) discovers and develops allosteric modulators for human health and is focused on validated therapeutic targets for diseases of the central nervous system, metabolic disorders and inflammation. Subject to regulatory approvals, Phase II clinical trials are expected to start soon in four indications for two lead products: ADX48621, an mGluR5 negative allosteric modulator (NAM), in dystonia and Parkinson’s disease levodopa- induced dyskinesia (PD-LID); and ADX71149, an mGluR2 positive allosteric modulator (PAM), in schizophrenia and anxiety. A third product, ADX71943, GABA-B receptor PAM with potential for chronic pain, is scheduled to enter Phase I testing in 2011. In addition, Merck & Co., Inc. has licensed rights to two preclinical products: mGluR4 PAM for Parkinson’s disease and mGluR5 PAM for schizophrenia. Additional preclinical discovery stage programs include: mGluR2 NAM; GLP1R PAM; IL1R1 NAM; and TNFR1 NAM. Roche Venture Fund and SR-One, corporate venture arm of GlaxoSmithKline, are investors in Addex.
Chris Maggos Investor Relations & Communications Addex Pharmaceuticals +41 22 884 15 11 chris.maggos@addexpharma.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 Pharmaceuticals Ltd, 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 Pharmaceuticals Ltd 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 mGluR2, mGluR4, mGluR5, mGluR7 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 mGluR2, mGluR4, mGluR5, mGluR7 will be approved for sale in any market or by any regulatory authority. Nor can there be any guarantee that allosteric modulators of mGluR2, mGluR4, mGluR5, mGluR7 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 mGluR2, mGluR4, mGluR5, mGluR7 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 Pharmaceuticals Ltd 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.
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