New Chemical Entity Improves Symptoms in Individuals With Treatment-Resistant Schizophrenia

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Interim results from an open-label study of evenamide as an add-on in patients with chronic treatment-resistant schizophrenia (TRS) showed an improvement in symptoms of psychosis in the first 100 participants.

The first-of-its-kind study is an international, 6-week, open-label, randomized, rater-blinded, multi-center study examining the effects of adding evenamide—a new chemical entity (NCE) antipsychotic—to treatment for 180 participants with TRS who are moderately to severely ill (CGI-S of 4 to 6), with a baseline PANSS score between 70 and 90, predominant positive symptoms, and functional deficits, who had not been responding to prior treatment with antipsychotic medications. Researchers are evaluating the tolerability and safety of adding evenamide orally at 3 fixed doses—7.5, 15, and 30 mg bid—compared with a stable therapeutic dose of a single antipsychotic (other than clozapine) as well as conducting safety and efficacy assessments in 1- to 2-week intervals. The study is being conducted by Newron Pharmaceuticals.¹

Interim results for the first 100 participants showed a 12% reduction in the participants’ PANSS scores, CGI-S improvement of 0.7, and CGI-C ratings demonstrating that 77% of participants responded to the treatment.¹

“We are excited to present the interim results of this study, which demonstrate the potential of evenamide as an add-on therapy to antipsychotics in patients with treatment-resistant schizophrenia,” said Ravi Anand, MD, Newron Pharmaceuticals chief medical officer, in a press release. “The data presented today confirm evenamide’s potential to improve symptoms of psychosis in patients who, despite treatment with various antipsychotics, continue to experience severe symptoms of psychosis and functional disabilities. These patients represent about one third of the overall schizophrenia population and thus a significant unmet medical need.”

As part of its ongoing Phase II/III development plan for evenamide, Newron announced it will initiate a multinational, randomized, placebo-controlled study in patients with TRS during the first quarter of 2023.¹ “Evenamide acts through selective attenuation of an abnormal release of glutamate and synergizing with the background antipsychotic activity,” Anand said in a press release. “The outcome of this study may change the treatment of future TRS patients when confirmed in a larger, placebo-controlled study.”

Reference

1. Newron presents encouraging interim results for evenamide in patients with treatment-resistant schizophrenia (TRS) at the 33rd CINP Hybrid World Congress of Neuropsychopharmacology. News release. Newron Pharmaceuticals. June 7, 2022. Accessed June 17, 2022. https://www.newron.com/news-and-media/regulatory-news/newron-presents-encouraging-interim-results-evenamide-patients