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Newron Pharmaceuticals to present three posters on evenamide in treatment-resistant schizophrenia at ECNP Congress 2025
Newron Pharmaceuticals announced that it will present three posters at the upcoming 38th Congress of the European College of Neuropsychopharmacology taking place in Amsterdam, the Netherlands, from October 11 to 14, 2025.
Results from previous Phase II (study 014/015) and Phase III (study 008A) studies have demonstrated clinically relevant benefits of evenamide. These studies in patients with treatment-resistant schizophrenia (TRS) or in poor responders to antipsychotic medication provided a significant and sustained improvement in TRS patients (up to and including one year) and an improvement in both positive and negative symptoms in poor responders, through evenamide’s glutamatergic modulating activity. In addition, evenamide was extremely well tolerated without the occurrence of any typical antipsychotic adverse events and with a minimal dropout rate.
Additional post-hoc analyses from data of these studies further support the unique long-lasting efficacy of evenamide. Over the course of a year, the proportion of responders increased throughout the study with more than 25% of patients achieving remission (i.e. sustained low symptoms level for at least six consecutive months) and more than 50% no longer meeting the protocol criteria for treatment resistance.
Treatment-resistance to antipsychotics is observed in about 30% of patients with schizophrenia, and clozapine, the most potent second-generation antipsychotic and the only approved medication for TRS, is highly underutilized. This is mainly explained by its serious side effects, need for regular monitoring and low tolerability. In contrast, results from previous studies with evenamide suggest that the drug is safe and well tolerated.
Together, these results paved the way for the launch of a potentially pivotal landmark phase III, randomized, one-year double-blind, placebo-controlled study for TRS: the ENIGMA-TRS 1 study (EveNamIde’s Glutamate Modulation Ameliorates TRS 1). The study’s unique design aims to address previous trials’ limitations by assessing the response to evenamide (15 and 30 mg bid) as an add-on to current second-generation antipsychotic (SGA) medication(s) in patients with TRS.
Poster presentations
1) Title: Evenamide Phase 3 Program: Study 023 (ENIGMA-TRS 1) evaluates the efficacy of add-on glutamate modulation in patients with documented treatment-resistant schizophrenia
Number: PS01-0225
Date: Saturday, October 11, 2025
2) Title: Success in the mechanism-based development of evenamide for patients with inadequate response or treatment-resistant schizophrenia
Number: EP08-0712
Date: Monday, October 13, 2025
3) Title: Glutamate modulation by evenamide produces statistically significant and clinically relevant improvement in patients with treatment-resistant schizophrenia
Number: PS04-3209
Date: Tuesday, October 14, 2025
