Add-on Evenamide Improves Symptoms in Patients With Schizophrenia

In patients with an inadequate response to a second-generation antipsychotic, adding evenamide improved schizophrenia symptoms, the drug’s developer Newron Pharmaceuticals recently announced.

The top-line results stemmed from a 4-week, double-blind, phase 2/3 study in 45 centers in 11 countries across Europe, Asia, and Latin America. Researchers randomized 291 patients to treatment with either with evenamide (30 mg twice daily) or placebo as an add-on to their current antipsychotic therapy.

According to Newron, the study met its primary endpoint of improvement on the Positive and Negative Syndrome Scale (PANSS) total score as well as the key secondary endpoint of improvement of the Clinical Global Impression of Severity (CGI-S). PANSS total score decreased of 10.2 points in patients with add-on evenamide compared with 7.6 points in patients with add-on placebo at day 29. The least square mean difference was 2.5. The least square mean difference between patients treated with evenamide and placebo was 0.16, with a corresponding P value of 0.037, on the CGI-S.

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Evenamide was safe and well-tolerated, the company reported. Three patients discontinued the study because of adverse events; two on evenamide and one on placebo who died during the study. The rate of patients who experienced at least one adverse event was 25% with evenamide and 25.8% with placebo. There was no difference between evenamide and placebo for the incidence of central nervous system, psychiatric, gastrointestinal, or other adverse events. The most common adverse events with evenamide were headache, vomiting, and nasopharyngitis, which were each reported by 3 patients.

“This is the first major international study to demonstrate the significant benefit of adding a new chemical entity (NCE) to poorly responding, compliant schizophrenia patients being treated with a second-generation antipsychotic,” said Ravi Anand, MD, Newron’s chief medical officer. “It is also the first demonstration of efficacy in a placebo-controlled trial of a NCE acting exclusively through glutamatergic inhibition.”

Evenamide will next be studied in a 1-year, double-blind, phase 3 randomized controlled trial in patients with treatment-resistant schizophrenia, the company said.

Reference

Newron announces positive top-line results from potentially pivotal phase II/III study 008A with evenamide in schizophrenia patients. News release. Newron Pharmaceuticals; April 30, 2024. Accessed May 17, 2024.