|By Marketwired .||
|November 27, 2012 01:22 AM EST||
GENEVA -- (Marketwire) -- 11/27/12 -- Addex Therapeutics / Addex' Dipraglurant Named as one of the "Top 10 Neuroscience Projects to Watch" by Windhover and Virginia Herndon . Processed and transmitted by Thomson Reuters ONE. The issuer is solely responsible for the content of this announcement.
(SIX: ADXN), a leading company pioneering allosteric modulation-based drug discovery and development, announced today that its lead program, dipraglurant has been named by Windhover and Virginia Herndon, as one of the Top 10 Neuroscience Projects to Watch. Addex recently reported positive data from a Phase 2a clinical study of dipraglurant (http://bit.ly/Yjp5GZ) in Parkinson's disease (PD) patients suffering from debilitating levodopa-induced dyskinesia (LID). Dr Bharatt Chowrira, CEO at Addex will be presenting the dipraglurant program at the Windhover's Therapeutic Area Partnerships meeting taking place on November 28-30, 2012 at the Westin Copley Hotel in Boston. The presentation is scheduled for November 29(th), 2012 at 1:40PM EST.
"We are honored by this recognition and excited by dipraglurant's potential to transform the lives of Parkinson's disease patients," said Dr. Bharatt Chowrira, CEO at Addex. "There is no approved treatment for dyskinesia, underscoring the huge unmet medical need in patients suffering from this debilitating condition. Dipraglurant has the potential to be first-in-class oral small molecule treatment that can change the treatment paradigm for Parkinson's disease. We look forward to rapidly advancing this program."
Companies selected for the Top 10 Neuroscience Projects to Watch honor have been screened against a strict set of criteria and represent what is considered the most attractive neuroscience opportunities the industry has to offer. The selection of dipraglurant as one of the Top 10 Neuroscience Projects met rigorous criteria, including: unmet medical need, market potential, diversity of indications, strong science, and multi-level partnering opportunities (biotech and pharma).
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), with potential to be used in combination with levodopa or dopamine agonists or as a standalone treatment for PD-LID, PD-related motor symptoms, non-motor symptoms of PD and other movement disorders. Data from a recent Phase 2a show 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 50mg and 100mg 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. Additional endpoints include the Unified Parkinson's Disease Rating Scale (UPDRS), the Clinician & Patient Global Impression of Change (CGIC & PGIC), and an evaluation of the patients' mood using the Hospital Anxiety & Depression Score. The trial was supported by a grant from The Michael J. Fox Foundation for Parkinson's Research.
A successful treatment for PD-LID would change the way Parkinson's disease is treated, by enabling physicians to use the most effective drug for Parkinson's disease - levodopa - earlier and more aggressively, according to market research carried out by Datamonitor for Addex. In addition, based on robust preclinical data, potential label expansions for dipraglurant include: PD motor symptoms and/or non-motor symptoms, like co-morbid anxiety and depression, as well as non-parkinsonian dystonias.
While dipraglurant has broad potential for treating Parkinson's and other diseases, the most direct path to market is treatment of PD-LID. No drug is approved for PD-LID and LID has been identified by the regulatory authorities, patient advocacy groups, such as The Michael J. Fox Foundation, and key opinion leaders as a very important unmet medical need. The potential market opportunity for dipraglurant in Parkinson's disease is well in excess of $1 billion, according to Datamonitor. Potential label expansions could more than double the peak sales potential for dipraglurant.
About Dyskinesia & PD
PD is a chronic, progressive neurological disorder that affects one in 100 people over the age 60 but as young as 18. Approximately 7.5 million people worldwide are suffering from this neurodegenerative disorder. The most commonly administered and "gold standard" drug to treat Parkinson's symptoms is levodopa (also called L-dopa), which helps restore levels of dopamine, a chemical messenger in the brain. Following prolonged use, approximately 80 percent of patients treated with levodopa will develop uncontrollable movements, i.e. dyskinesias, a major source of disability in their lives. To learn about dyskinesia, listen to this podcast (http://bit.ly/Tq9PEt) featuring Dr. Sherer and produced by The Michael J. Fox Foundation for Parkinson's Research or find additional information on PD at the Foundation's website (www.michaeljfox.org).
There is increasingly convincing evidence that mGluR5 inhibition may be a valuable new strategy for treating a number of important diseases and conditions, such as Parkinson's disease, PD-LID, anxiety, depression, pain, tardive dyskinesia, addiction, autism and Fragile X syndrome. With regards to Parkinson's disease, recent clinical and preclinical evidence suggest that mGluR5 inhibition may have an effect on parkinsonian motor symptoms as well dyskinesia. mGluR5 is found in regions of the brain considered to be key control points in the neuronal movement circuits affected by abnormal signaling by the neurotransmitter glutamate in PD. Perturbations in glutamate signaling (along with disruptions in dopaminergic signaling) are believed to be an underlying cause of movement disorders like Parkinson's disease. As such, inhibiting mGluR5 could act to re-establish normal movement via a non-dopaminergic mechanism. Separately, preclinical findings also suggest that mGluR5 inhibitors may be neuroprotective and may, therefore, hold potential as disease modifying agents that can slow or prevent progression of PD.
Addex Therapeutics (www.addextherapeutics.com) discovers and develops an emerging class of small molecule drugs, called allosteric modulators, 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 address receptors and other proteins that are recognized as attractive targets for modulation of important diseases with unmet medical needs. The Company's two lead products are being investigated in Phase 2 clinical testing: dipraglurant (ADX48621, an mGluR5 negative allosteric modulator or NAM) is being developed by Addex to treat Parkinson's disease levodopa-induced dyskinesia (PD-LID); and ADX71149 (mGluR2 positive allosteric modulator or PAM) is being developed in collaboration with Janssen Pharmaceuticals Inc. to treat schizophrenia and anxiety seen in patients suffering from major depressive disorder. Addex also is advancing several preclinical programs including: GABA-BR PAM for spasticity in MS, OAB and other disorders; mGluR4 PAM for Parkinson's, MS, anxiety and other diseases. In addition, Addex is applying its proprietary discovery platform to identify highly selective and potent allosteric modulators of a number of both GPCR and non-GPCR targets that are implicated in diseases of significant unmet medical need.
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 mGluR2, mGluR4, mGluR5, 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 mGluR2, mGluR4, mGluR5, 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 mGluR2, mGluR4, mGluR5, 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 mGluR2, mGluR4, mGluR5, 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.
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