Newron’s add-on schizophrenia therapy mets endpoints in Phase II/III trial

Newron Pharmaceuticals' evenamide study has achieved its primary endpoint, demonstrating improvement in positive and negative symptoms, and severity in patients with treatment-resistant schizophrenia. The Italian biopharma's add-on treatment evenamide met primary and secondary endpoints in a Phase II/III trial.

The placebo-controlled trial assessed evenamide as an add-on therapy with a second-generation antipsychotic, including clozapine, in 291 chronic schizophrenia patients. It successfully improved symptom severity measured by the PANSS Total Score and the Clinical Global Impression of Severity (CGI-S).

Evenamide showed favorable safety and tolerability, with 25% experiencing adverse events. Notably, three participants discontinued the trial due to adverse events, including one death in the placebo group.

Newron's stock price surged by 17.8% following the release of topline results. They plan a potentially pivotal Phase III trial for evenamide in treatment-resistant schizophrenia.