Newron Pharmaceuticals S.p.A. (<strongSIX: NWRN, XETRA: NP5) announced it will present research on its lead compound, evenamide, at the 17th World Congress of Biological Psychiatry (WCBP) in Berlin, Germany, from September 9-12, 2025. The company will deliver both oral and poster presentations.
One presentation will cover data from Study 008A, a Phase 2/3 trial. This study examined evenamide as an add-on treatment for schizophrenia patients who had an inadequate response to second-generation antipsychotics, including clozapine. The results showed that evenamide‘s glutamate modulation led to statistically significant improvements in clinical outcomes. Importantly, the trial demonstrated that adding another antipsychotic could improve efficacy. Evenamide demonstrated a favorable safety profile in this study.
Another presentation will focus on the ENIGMA-TRS 1 study. This is a pivotal Phase 3, randomized, double-blind, placebo-controlled trial evaluating evenamide as an add-on therapy for treatment-resistant schizophrenia (TRS). The study is designed to overcome limitations of previous trials by utilizing stricter eligibility criteria and monitoring antipsychotic medication compliance. The study, enrolling over 600 participants across multiple countries, will assess both short- and long-term efficacy.
A third poster presentation will compare the safety and tolerability of evenamide to three recently approved antipsychotics. This analysis will examine the relative risk of adverse events compared to placebo, considering the different mechanisms of action.
The presentations will take place on Wednesday, September 10, and Thursday, September 11, 2025.
Treatment-resistant schizophrenia (TRS) affects a substantial portion of schizophrenia patients, who show little to no improvement despite adequate treatment with two or more antipsychotics. Research suggests that abnormalities in glutamate neurotransmission may contribute to TRS.
Evenamide is a novel oral compound that selectively blocks voltage-gated sodium channels, normalizing glutamate release without impacting basal levels. Preclinical studies have shown potential synergy between evenamide and other antipsychotics, suggesting it could benefit patients unresponsive to current treatments.
Newron is a biopharmaceutical company focused on therapies for central and peripheral nervous system diseases. The company is headquartered in Bresso, near Milan, Italy. Newron has development and commercialization agreements in place for evenamide in various territories. The company also has a history of successfully bringing central nervous system therapies to market.
This press release contains forward-looking statements that involve risks and uncertainties. Actual results may differ materially from those projected. Investors are urged to review the full disclaimer in the original press release.
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