GENEVA--(Marketwire - Sep 24, 2012) - Addex Therapeutics / Addex mGluR4 Allosteric Modulator Effective in Multiple Sclerosis Model - A Novel Oral Small Molecule Approach for the Treatment of Multiple Sclerosis.

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Addex Therapeutics (SIX: ADXN), a leading company pioneering allosteric modulation-based drug discovery and development, announced today achievement of a positive Proof of Concept for its lead metabotropic glutamate receptor 4 (mGluR4) positive allosteric modulator (PAM) compound series in a validated rodent model for multiple sclerosis (MS). MS is a chronic inflammatory demyelinating auto-immune disease that affects the central nervous system (CNS), leading to serious disability.

"We are very excited that this promising Addex mGluR4 PAM series may offer a differentiated approach to treating MS," said Professor Ursula Grohmann, of University of Perugia, Italy, in whose laboratories one of these studies was performed. "These data confirm our previous observations, using an mGluR4 PAM tool compound called PHCCC, which demonstrated efficacy in the industry standard neuroinflammation model of MS, the Relapsing-Remitting Experimental Allergic Encephalomyelitis (RR-EAE) model. In this study, the mGluR4 PAM worked by promoting regulatory T-cell (Treg) formation and reversing pro-inflammatory T-cell release. Therefore, we believe that positive modulation of mGluR4 could potentially stop the destruction of myelin in MS in a robust and durable manner."

Addex lead chemical series is a highly selective orally available mGluR4 PAM and shows good pharmacokinetic properties for potential once-daily dosing. When administered once a day for 3 weeks at 10, 30 and 60 mg/kg sc, Addex mGluR4 PAM demonstrated a dose-dependent, statistically significant reduction in paralysis (clinical score) and the relapse rate in the RR-EAE model of MS in mice. The presentation of these data is being planned for a major international conference.

"Current MS therapies are primarily focused on reinstating motor function after an inflammatory attack, preventing new attacks, and preventing or treating disability and symptoms, such as spasticity. In addition, most of these therapies are primarily based on immunomodulatory strategies, and have serious compliance-limiting side effects", noted Graham Dixon, CSO of Addex Therapeutics. "We believe a well-tolerated, oral mGluR4 PAM would represent a major advance in the treatment of MS because of the novel and potentially broader mechanism; having the potential to not only treat symptoms, but slow disease progression and offer neuroprotection. We are now rapidly advancing this lead series towards a clinical candidate and conducting experiments to further elucidate the biological role of mGluR4 PAM in MS."

"Moving the lead compound from this series into full development in 2012 clearly illustrates our strategy of advancing innovative novel selective oral small molecule drug candidates against previously "undruggable" targets" said Bharatt Chowrira, CEO of Addex Therapeutics. "These data along with the recently announced data on the role of the mGluR4 PAMs in Parkinson's disease, the positive Phase 2 data for dipraglurant in Parkinson's disease levodopa-induced dyskinesia, the two Phase 2 clinical trials being conducted by our partner Janssen, and our GABABR PAM program advancing towards an IND filing later this year, demonstrate the power of Addex platform that continues to generate multiple, novel high value product opportunities."

About Multiple Sclerosis

Multiple sclerosis, is an idiopathic inflammatory disease of the central nervous system, characterized pathologically by demyelination and subsequent axonal degeneration. The disease commonly presents in young adults and affects twice as many women as men. Common presenting symptoms include numbness, weakness, visual impairment, loss of balance, dizziness, urinary bladder urgency, fatigue, and depression. Approximately 2.5 million people worldwide are affected with prevalence ranging from 2 and 150 per 100,000, depending on the country and specific population. MS takes several forms. The most common affecting around 85 per cent of everyone diagnosed with MS is relapsing remitting MS (RRMS). It means that symptoms appear (a relapse), and then fade away, either partially or completely (remitting). Secondary progressive MS (SPMS) is a stage of MS which comes after RRMS in many cases. Although the pathogenesis of MS is complex and not fully understood, it is believed that RRMS is characterized by repeated episodes of inflammation which eventually leads to the axonal degeneration through damage to, and loss of the myelin sheath characteristic of SPMS. Given the prominence of immune generated inflammation in MS, treatments for the disease have focused particularly on immunosuppressive anti-inflammatory strategies. Currently approved treatments for RRMS are only partially effective in reducing MS relapses and in particular do not halt disability progression. As these drugs alter immune function, patients can experience serious and sometimes life threatening side effects (e.g. opportunistic infections, emergent malignancies, alopecia, cardiotoxicity and myelosuppression). Furthermore, many of these agents also require regular injection, or parenteral infusions which are uncomfortable and inconvenient for the patient.

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Addex mGluR4 Allosteric Modulator Effective in Multiple Sclerosis Model - A Novel Oral Small Molecule Approach for the ...

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(CBS News) There's a new treatment for multiple sclerosis, or MS, which affects more than 400,000 Americans.

MS can strike anyone at any time, but it usually hits adults in the prime of their lives. But researchers say a new drug is proving very promising.

FDA approves new multiple sclerosis treatment Aubagio

As an electrician, 49-year-old Stephen O'Malley depends on good vision. But seven years ago, things suddenly began to go dark.

O'Malley recalled, "I was scared to death. I went to work at 6:00 in the evening and I was completely blind in one eye six hours later."

The Cleveland father of two was diagnosed with MS. MS is a neurological disease that affects the brain and spinal cord. Symptoms can range from numbness and tingling to blindness and paralysis. They usually get worse over time, leaving many patients greatly disabled.

While there is no cure for MS, there are effective treatments. Kate Lodge gets monthly infusions requiring a two-hour visit to the hospital, but there are scary potential side effects, including fatal brain infections.

"The symptoms of the brain infection can mirror the symptoms of MS, so you can't know," Lodge said. "And so you go into a panic mode."

Dr. Robert Fox is medical director at the Cleveland Clinic's Mellen Center for Multiple Sclerosis. He said what was needed in an MS treatment is a combination of effective therapy that's well tolerated and safe.

And now, that therapy may finally be here in an easy-to-take pill form.

Read more from the original source:
New drug shows promise in multiple sclerosis treatment, researchers say

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Readmore: Local, Health, Education, Community, Economy, News, Science, Technology, MS, Multiple Sclerosis, People Living with MS, Walk to End MS, Superior Dome, Fight MS, Marquette, Cause, Community Outreach

MARQUETTE -- Dozens who helped an important cause in Marquette this Sunday didn't have to worry about the rain in order to do so. They did it all inside the Superior Dome.

This is the first walk the regional Multiple Sclerosis organization has done in a few years. The walk for Multiple Sclerosis is part of a national push that supports cutting edge research and providing services to help people with MS move their lives forward.

"The money for this walk and for MS in general is very important for research and hopefully to find a cure," said Lisa Taylor, an organizer and head of the local support group in Marquette.

"And it goes to people who can't afford medication, or people who need walkers or canes or wheelchairs."

To find out more about their cause, click here.

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Dozens walk to support Multiple Sclerosis cause

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New drug shows promise in multiple sclerosis treatment, researchers say FDA approves new multiple sclerosis treatment Aubagio Commonly prescribed interferon beta does not delay multiple sclerosis progression in study

Each week 200 or more Americans are diagnosed with multiple sclerosis, according to the National Multiple Sclerosis Society. The autoimmune disease causes the body's natural defenses to attack the central nervous symptom, resulting in symptoms that range from mild, including numbness in the limbs, to severe symptoms like disability, loss of vision or paralysis. Most people are diagnosed between 20 and 50, NMSS says.

There are four types of MS, with 85 percent of patients initially diagnosed with what's called relapsing-remitting MS. People with relapsing-remitting MS often have attacks - called relapses, flare-ups or exacerbations - that may worsen neurological function, which are followed by partial or complete recovery (remission) periods.

The trials for BG-12 were phase III, which is often the step closest to a drug's approval when scientists gather more data on its safety and efficacy. BG-12 is manufactured by Massachusetts based-Biogen Idec, which is seeking FDA approval on the drug. The drugmaker funded the new studies, which were published online Sept. 20 in the New England Journal of Medicine.

The first study - known as the DEFINE trial - looked at 1,200 people to determine whether a BG-12 pill could reduce the frequency of relapses compared to people with MS who were taking a placebo pill.

Participants were split into three groups: those taking 240 milligrams of the pill twice a day, those taking 240 milligrams three times a day and those taking a placebo. At two years, both groups taking BG-12 experienced significant reductions in relapses (49 percent and 50 percent reductions respectively) compared with placebo-takers.

Taking BG-12 also led to significant reductions in risk of MS progressing to disability for the patients. MRI scans confirmed pill-takers had fewer new or active MS lesions than scans of people taking placebo.

The next trial, led by Dr. Robert J. Fox, medical director at the Cleveland Clinic's Mellen Center for Multiple Sclerosis, included 1,400 people with MS to determine whether BG-12 could reduce the average yearly relapse rate for patients at two years.

Similar to DEFINE, this study - known as the CONFIRM trial - measured relapse rates of patients taking either a 240 milligram dose of BG-12 twice a day or three times a day, comparing them a group taking placebo. A fourth group was assigned to receive the injectable MS drug, glatiramer acetate, which is sold as Copaxone and was FDA-approved in 1996 to reduce the frequency of relapses in patients with relapsing-remitting MS.

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Experimental multiple sclerosis pill reduces flare-ups in studies, adding hopes for new treatment option

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