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Positive results for Newron phase II study of evenamide for schizophrenia

Wednesday, April 6, 2016

Newron Pharmaceuticals, an Italy-based biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central nervous system (CNS) and pain, has presented results for Evenamide (NW-3509), a putative antipsychotic that targets abnormal electrical activity and glutamatergic abnormalities in improving psychotic symptoms in patients with schizophrenia, in a phase II, placebo-controlled trial.

Evenamide (NW-3509) is a new generation antipsychotic that acts through pathways that are not targeted by current treatments or other putative antipsychotics. It is associated with a functional blockade of voltage-gated sodium channels that inhibits glutamate release by reducing the firing rate of hyper-excited neurons and may normalize aberrant cortical and hippocampal activity. A phase II, placebo-controlled study in patients with schizophrenia experiencing breakthrough symptoms while on adequate doses of risperidone or aripiprazole is ongoing, in which Evenamide is being evaluated at doses of 15-25mg bid as add-on therapy for reducing positive symptoms and psychotic worsening.

Ravi Anand, M.D., Newron’s chief medical officer, said, “Evenamide (NW-3509) has demonstrated in preclinical models that it provides inhibition of voltage-gated sodium channels without any effect on receptors, enzymes and transporters targeted by most antipsychotics and yet is active in most animal models of psychosis. Intriguingly, in animal models of psychosis, the addition of ineffective doses of both NW-3509 and typical or atypical antipsychotics, showed significant benefit. This finding, if confirmed in poorly responding patients, would suggest that the current practice of switching non-responding patients to another antipsychotic be replaced by the addition of NW-3509 to their regimen. This would avoid such issues as discontinuation effects, need to hospitalize patients, anti-dopaminergic, metabolic and sexual side effects.”

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