Positive Results from Phase II/III Evenamide Study in Schizophrenia Patients

Newron Pharmaceuticals, a biopharmaceutical firm dedicated to developing innovative treatments for central and peripheral nervous system disorders, has reported promising results from a pivotal study of its drug evenamide. The research, conducted across 45 centers in 11 countries, aimed to assess the drug's safety, tolerability, and efficacy in chronic schizophrenia patients who showed limited response to second-generation antipsychotics, including clozapine.

The study, designated 008A, was a four-week, randomized, double-blind, and placebo-controlled trial that served as an add-on to the existing antipsychotic therapy of 291 enrolled patients. The primary goal was to observe improvements on the Positive and Negative Syndrome Scale (PANSS) Total Score, and the key secondary goal was to assess changes in the Clinical Global Impression of Severity (CGI-S). Evenamide successfully met both objectives, demonstrating a statistically significant reduction in PANSS Total Score and a favorable CGI-S outcome.

Evenamide was well-tolerated, with a high completion rate among participants. Adverse events were minimal and comparable to those experienced by patients on placebo, with no new safety concerns arising. The most frequently reported side effects included headache, vomiting, and nasopharyngitis, affecting a small number of patients.

The drug's innovative mechanism involves inhibiting glutamatergic activity, offering a novel therapeutic approach for schizophrenia patients who do not respond well to current treatments. The positive results from study 008A are particularly noteworthy as they mark the first significant demonstration of the benefits of adding a new chemical entity to the treatment regimen of patients with inadequate responses to second-generation antipsychotics.

Dr. Ravi Anand, Newron's Chief Medical Officer, highlighted the groundbreaking nature of the study, emphasizing the importance of glutamate's role in developing new treatment options for schizophrenia. The company is now poised to move forward with a potentially pivotal Phase III trial, focusing on treatment-resistant schizophrenia (TRS), and aims to further explore the synergistic effects of evenamide with other antipsychotics.

Evenamide, an orally administered new chemical entity, specifically targets voltage-gated sodium channels, normalizing glutamate release without affecting baseline levels. The drug has shown potential synergies with other antipsychotics, including clozapine, in preclinical models of psychosis.

Newron Pharmaceuticals, headquartered in Italy, is also known for Xadago®/safinamide, a treatment for Parkinson's disease that has received marketing authorization in several regions globally. The company continues to advance evenamide as a potential first-line add-on therapy for schizophrenia, with additional study details to be released in the coming weeks.