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Newron Pharmaceuticals (NWRN) Release: New Results With NW-3509 Presented At SIRS Conference

4/8/2014 4:08:51 PM

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Unique mechanism has potential to benefit poor responders to antipsychotics In patients with schizophrenia; NW-3509 well tolerated and safe in Phase I trial - Newron to initiate Phase II study in 2014

Milan, Italy – April 8, 2014 - Newron Pharmaceuticals S.p.A. (“Newron”), a research and development company focused on novel CNS and pain therapies, announced today that results from new mechanistic and behavioral studies with NW-3509 confirm its potential for use in patients with schizophrenia. These studies, together with preliminary results from a US Phase I study have been presented at the 4th Biennial Schizophrenia International Research Society (SIRS) Conference on Monday 7th April, 2014 in Florence, Italy.

New mechanistic studies have confirmed NW-3509’s selectivity to block voltage gated sodium channels (VGSCs) based on the evaluation of over 130 targets including receptors, channels, transporters and enzymes. This blockade leads to the inhibition of excessive glutamate release that has not been addressed by current antipsychotics. These effects make NW-3509 unique and give it the potential to improve inadequate response when used in conjunction with marketed antipsychotics in patients with schizophrenia.

New behavioural studies with NW-3509, either alone or in combination with first or second generation antipsychotics, demonstrated significant activity in animal models (increased locomotion, aggression, pre-pulse inhibition, cognitive impairment) of schizophrenia independent of the stimulus (amphetamine, MK-801, PCP, scopolamine, sleep deprivation, natural impairment) used to produce the deficit. Benefits have also been demonstrated in animal models of mania, depression and obsessive/compulsive disorders.

Results from an ongoing Phase I trial in healthy volunteers in the US have indicated that NW-3509 at the doses administered is well tolerated, and exposure increases with increasing dose. Exposure in humans measured at the current doses overlap with exposure demonstrated at doses associated with significant benefit in animal models. Ravi Anand, Newron’s CMO, commented: ”Schizophrenia is associated with inadequate response to current antipsychotic therapy in a large proportion of patients despite adequate blockade of serotoninergic, mesolimbic and mesocortical dopaminergic systems. NW-3509 will modulate abnormal electrical activity in the brain and inhibit excessive glutamate release, thus providing additional mechanisms that will enhance the benefit provided by current antipsychotics. During fourth quarter 2014, Newron plans to initiate a placebo-controlled safety and efficacy trial in schizophrenic patients who are poor responders to current treatment.”

Marco Caremi, Newron’s Executive VP BD, added: “In 2013, Newron was granted the composition of matter patent on NW-3509 in the US. The patent has also been granted in other territories including Japan. In Europe, the application is under examination. This patent will protect the compound until 2028, plus potential extensions and such a patent exclusivity term allows future partners in the development of the compound sufficient time to recover their investment.”

About Newron Pharmaceuticals

Newron (SIX: NWRN) is a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the Central Nervous System (CNS) and pain. The Company is headquartered in Bresso near Milan, Italy. Following the submission of the Marketing Authorization Application (MAA) for safinamide for the treatment of Parkinson’s disease to the European Medicines Agency (EMA) in December 2013, as well as to Swissmedic in March, 2014, Newron is working to complete the global filing of the compound, together with its partners. Zambon Group has the rights to commercialize safinamide globally, excluding Japan and other key Asian territories where Meiji Seika has the rights to develop and commercialize the compound. Newron’s additional projects are based on highly promising treatments for rare disease patients and are at various stages of clinical development, including sNN0031 for patients with Parkinson’s disease, non-responsive to oral drug treatments, sarizotan for patients with Rett syndrome, sNN0029 for patients with ALS and ralfinamide for patients with specific rare pain indications. Newron is concurrently developing NW-3509 as the potential first add-on therapy for the treatment of patients with positive symptoms of schizophrenia.

For more information
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Martin Meier-Pfister
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Stefan Weber - CEO
Phone: +39 02 6103 46 30

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