Milan, Italy – July 13, 2011 – Newron Pharmaceuticals S.p.A. (“Newron”), a research and development company focused on novel CNS and pain therapies announced today that it has submitted to the US FDA an investigational new drug (IND) application for NW-3509, the first selective, voltage gated sodium channel (VGSC) modulator, being specifically developed for schizophrenia therapy. The application is seeking FDA approval to conduct a first human dosing trial in non-patient volunteers. The IND submission follows prior meetings with the FDA and MHRA (UK) and incorporates their suggestions and recommendations.

NW-3509 has demonstrated activity in numerous models that mimic psychotic disorders, especially schizophrenia, both as monotherapy and as add-on treatment to currently available antipsychotics. It significantly reduces abnormalities in pre-pulse inhibition (PPI), a measure of information processing and cognition, that has shown to be abnormal in patients with schizophrenia. The addition of NW-3509 to the treatment regimen of patients who are not benefitting adequately from their current medication, has the potential to result in clinical benefits and to allow the use of lower dose anti-psychotic treatments, thus significantly reducing dosedependent side effects.

NW-3509 is an innovative compound from a new chemical class, stemming from Newron’s ion channel programme. Its mechanism of action involves selective modulation of voltage-gated sodium channels (VGSC) that have been implicated in the pathogenesis of psychiatric and neurological disorders.

Ravi Anand, M.D., Newron’s Chief Medical Officer, said, “NW-3509 provides a unique approach to the treatment of patients with psychosis who are not responding to the currently available treatments, that largely block dopaminergic and serotonergic receptors. NW-3509, instead, targets voltage gated sodium channels, providing the opportunity to normalize aberrant neuronal firing and glutamatergic hyperactivity, that have been implicated in the patho-physiology of schizophrenia.

Therefore, the addition of NW-3509 to the current treatments may extend the benefits in symptoms of psychosis and significantly reduce the side effects experienced by patients.”