New results with NW-3509 presented at SIRS Conference

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."


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