Newron Notes the Publication of New Preclinical Research Suggesting Evenamide Ameliorates Schizophrenia-Related Dysfunction
Ad hoc announcement pursuant to Art. 53 LR
New findings published in Neuropsychopharmacology are the first to demonstrate that evenamide targets the key site of schizophrenia pathology in the hippocampus, and so could be an ideal therapeutic agent for treatment of the disorder
Systemic, acute administration of evenamide in the neurodevelopment MAM model of schizophrenia improved positive, negative and cognitive symptoms of schizophrenia
Time-course analysis indicates effects of a single dose of evenamide last long after elimination of drug, suggesting effect on neuronal plasticity
Evenamide’s glutamate modulation may improve overall outcomes in poorly responding or treatment resistant patients with schizophrenia on current antipsychotics, offering a novel strategy for managing the disorder
Schizophrenia is a neurodevelopmental disorder affecting approximately 1% of the world’s population, and is characterized by positive, negative, and cognitive symptoms. However, current dopamine D2 antagonist-based antipsychotic drugs only address primarily positive symptoms. It is known that limbic hippocampus hyperexcitability is a key pathological state of schizophrenia and therefore represents an ideal therapeutic target. This newly published research shows how evenamide, a selective voltage-gated sodium channel blocker, uniquely targets hippocampal hyperexcitability and selectively inhibits hyperactive neurons. Additionally, time-course analysis indicates effects of a single dose of evenamide last long after its elimination, suggesting evenamide may have an effect on neuronal plasticity. Studies to date suggest evenamide is devoid of activity at any other central nervous system target, and it normalizes excessive synaptic glutamate induced by NMDA hypofunction.
“The study examined the effect of acute evenamide treatment on the hyperdopaminergic state, hippocampal hyperexcitability, social deficits, and recognition memory in the methylazoxymethanol acetate (MAM) neurodevelopmental model,” explained
“The study findings suggest that evenamide has high therapeutic potential for treating multiple symptom domains of schizophrenia,” said Senior study author Dr.
“The recognition memory improvement induced by evenamide in the study’s MAM model may indicate that it may also enhance cognitive function in patients with schizophrenia and ultimately lead to a better functional outcome,” continued Grace. “Current D2-based antipsychotic agents do not effectively address cognitive symptoms, which limits their overall efficacy and produces a significant functional burden on patients. Therefore, evenamide would offer advantages over existing antipsychotic drugs by targeting positive symptoms, cognitive deficits and social isolation.”
“This study provides important learnings, which explain the results of our earlier
About schizophrenia
Approximately 25 million people worldwide are affected by schizophrenia. Despite more than 60 different types of atypical and typical antipsychotics used to treat schizophrenia globally, a considerable number of patients remain severely ill or resistant to treatment. Overall, 30-50% of patients do not respond to the available medications and are defined as treatment resistant. In addition to the patients with treatment-resistant schizophrenia (TRS), another 20-30% are described as “poor responders to antipsychotic medication”, even if not meeting the criteria for TRS. New findings indicate that patients with TRS have abnormalities in the glutamatergic system, but not in dopaminergic transmission, so there is a significant unmet medical need for treatments with a glutamatergic mechanism of action, efficacious both in TRS patients and in those who are poor responders to the current treatments.
About evenamide
Evenamide is the first new chemical entity that has demonstrated significant benefits in this difficult-to-treat patient population, as seen in the potentially pivotal Phase III study 008A trial, as an add-on treatment to second generation antipsychotics including clozapine, in 291 poorly responding patients with chronic schizophrenia. The primary endpoint, the Positive and Negative Syndrome Scale (PANSS)2, and the key secondary endpoint, the Clinical Global Impressions Scale – Severity (CGI-S), were met and showed statistical significance compared to placebo. Importantly, evenamide treatment was associated with statistically significant increases in the proportion of patients who experienced “clinically meaningful benefit” on the outcome variables. Evenamide was extremely well tolerated, without any of the usual side effects of available antipsychotics.
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Newron (SIX: NWRN, XETRA: NP5) is a biopharmaceutical company focused on developing novel therapies for patients with diseases of the central and peripheral nervous system.
Headquartered in Bresso, near
Newron has signed development and commercialization agreements for evenamide with EA Pharma (a subsidiary of Eisai) for
Newron has a proven track record in bringing CNS therapies to market. Its Parkinson’s disease treatment, Xadago® (safinamide), is approved in over 20 markets, including the
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1 Uliana DL, Walsh RA, Fabris D and Grace AA. Evenamide reverses schizophrenia-related dysfunction in a neurodevelopmental animal model, Neuropsychopharmacology (2025); https://doi.org/10.1038/s41386-025-02188-y
2 Positive and Negative Syndrome Scale (PANSS) is widely used in clinical trials of schizophrenia and is considered the “gold standard” for assessment of antipsychotic treatment efficacy (Innvo Clin Neurosci, 2017: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5788255/)
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