Italian biopharmaceutical company Newron Pharmaceuticals S.p.A. (SIX:NWRN) (XETRA:NP5) announced on Friday that it has completed patient enrolment in its potentially pivotal study of evenamide in patients with schizophrenia.

Study 008A, assessing the efficacy, tolerability and safety of evenamide (30 mg bid), targets patients with chronic schizophrenia inadequately responding to second-generation antipsychotic treatment. With 290 participants across study centres in Europe, Asia and Latin America, results from the four-week, randomised, double-blind and placebo-controlled study are anticipated in March 2024.

Considered a potentially groundbreaking development, a positive outcome from study 008A would mark the first well-controlled demonstration of evenamide's clinical utility for schizophrenia patients with inadequate responses to atypical antipsychotics.

Evenamide, an orally available new chemical entity, specifically blocks voltage-gated sodium channels (VGSCs) and is devoid of biological activity at over 130 other central nervous system (CNS) targets. It normalises glutamate release induced by aberrant sodium channel activity (veratridine-stimulated), without affecting basal glutamate levels.