The randomised, double-blind trial will assess the safety, efficacy and tolerability of two daily 30mg doses of evenamide in chronic schizophrenia patients over four weeks.
Patients who are currently being treated with second-generation antipsychotics but are showing an inadequate response are eligible to be part of the trial.
The trial has so far enrolled 290 subjects across trial sites in Asia, Europe and Latin America.
Newron expects to publish the trial data in March 2024.
Subject to positive trial data, the study could become a milestone in treating schizophrenia, particularly for patients who do not respond well to current antipsychotic drugs.
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Evenamide is an orally available new chemical entity that hinders the voltage-gated sodium channels (VGSCs).
It is unique as it has no biological activity at more than 130 other central nervous system targets.
The compound works by normalising glutamate release elicited by abnormal sodium channel activity, without impacting basal glutamate levels.
In animal psychosis models, combinations of ineffective doses of evenamide with other antipsychotics, including clozapine, were proven to have benefits.
In March 2023, Newron reported topline data from Study 014, a global, open-label Phase II trial of evenamide.
The trial assessed the entity as an add-on to existing antipsychotics (excluding clozapine) in moderate to severe treatment-resistant schizophrenia patients.
Findings showed that 95% of the trial subjects finished the six-week treatment period and 94% of the completers entered the extension study.
Treatment with evenamide was found to offer substantial improvement in mean Clinical Global Impression of Severity rating, Positive and Negative Syndrome Scale total score and the Strauss-Carpenter Level of Functioning total score versus baseline.