Newron Showcases Latest Research at the 2026 Schizophrenia International Research Society Annual Congress 2026
Newron Pharmaceuticals S.p.A., a clinical-stage biopharmaceutical company dedicated to advancing innovative therapies for disorders affecting the central and peripheral nervous systems, has announced its active participation in the upcoming Schizophrenia International Research Society Annual Congress 2026. The prestigious international meeting, scheduled to take place from March 25 to 29, 2026, will be held at the Firenze Fiera in Florence, bringing together leading researchers, clinicians, and industry experts focused on advancing the understanding and treatment of schizophrenia.
Newron’s presence at SIRS 2026 underscores its growing role in neuropsychiatric drug development, particularly through its lead investigational compound, evenamide. The company will contribute to the scientific program through a dedicated workshop presentation as well as three scientific posters, all centered on the therapeutic potential of evenamide in addressing treatment-resistant schizophrenia (TRS), one of the most challenging areas in modern psychiatry.
Advancing Scientific Dialogue Through Workshop Participation
A key highlight of Newron’s participation will be its involvement in a scientific workshop scheduled for Wednesday, March 25, 2026, from 3:30 to 5:30 PM CET, held in the Auditorium. The workshop, titled “Use of Biomarkers in Evaluating Novel Treatments for Patients with Schizophrenia,” will provide a platform for discussing emerging approaches in drug development and patient stratification.
Within this session, Newron will present findings on the modulation of glutamate in patients with treatment-resistant schizophrenia, drawing from clinical trial data involving evenamide. This presentation will explore how targeting glutamatergic pathways—an area increasingly recognized as central to schizophrenia pathophysiology—may offer new therapeutic opportunities beyond traditional dopamine-focused treatments. By participating in this workshop, Newron aims to contribute to the evolving scientific consensus around biomarker-driven drug development and precision psychiatry.
Poster Presentations Highlighting Evenamide’s Clinical and Preclinical Profile
In addition to the workshop, Newron will present three posters across multiple days of the congress, each shedding light on different aspects of evenamide’s mechanism, clinical efficacy, and patient-centered outcomes.
The first poster, scheduled for Thursday, March 26, will present novel findings derived from a neurodevelopmental animal model of schizophrenia. These data provide compelling evidence supporting the long-term clinical benefits of evenamide in treatment-resistant populations. The findings suggest that the drug’s unique pharmacological activity may influence disease progression in ways not previously achievable with existing therapies.
On Friday, March 27, Newron will present an update from its Phase III ENIGMA-TRS clinical program. This poster will focus on the ongoing pivotal trials evaluating evenamide as an add-on therapy in patients with TRS. The data presented are expected to provide insights into the drug’s efficacy, safety, and tolerability profile, as well as its potential to address unmet clinical needs in patients who do not respond adequately to standard antipsychotic treatments.
The third poster, to be presented on Saturday, March 28, will examine the broader impact of evenamide on patient quality of life. Specifically, it will highlight improvements in social functioning and life engagement among patients with treatment-resistant schizophrenia or those who exhibit inadequate responses to second-generation antipsychotics. These findings emphasize the importance of moving beyond symptom control to address functional outcomes that significantly affect patients’ daily lives.
The ENIGMA-TRS Phase III Program: A Pivotal Development Effort
At the core of Newron’s clinical strategy is the ENIGMA-TRS Phase III development program, which comprises two major studies: ENIGMA-TRS 1 and ENIGMA-TRS 2. Together, these trials are designed to rigorously evaluate evenamide’s potential as a first-in-class add-on therapy for patients with treatment-resistant schizophrenia.
ENIGMA-TRS 1, initiated in August 2025, is a global, one-year, randomized, double-blind, placebo-controlled study enrolling at least 600 patients. This trial is designed to assess the efficacy, safety, and tolerability of evenamide administered at doses of 15 mg and 30 mg twice daily, in combination with existing antipsychotic treatments, including clozapine. By incorporating a long-term study duration, ENIGMA-TRS 1 aims to evaluate sustained therapeutic effects and long-term safety outcomes.
Complementing this study is ENIGMA-TRS 2, which began in December 2025. This trial is a 12-week, randomized, double-blind, placebo-controlled study expected to enroll at least 400 patients. It focuses on the efficacy and safety of a 15 mg twice-daily dose of evenamide as an add-on therapy. Together, these trials form a comprehensive clinical program that could support regulatory submissions and ultimately lead to a new treatment option for TRS patients worldwide.
Evenamide: A First-in-Class Glutamate Modulator
Evenamide represents a novel approach to treating schizophrenia, distinguished by its unique mechanism of action. Unlike traditional antipsychotics, which primarily target dopamine receptors, evenamide selectively inhibits voltage-gated sodium channels (VGSCs). This action leads to the normalization of excessive glutamate release associated with abnormal neuronal activity, without disrupting normal baseline glutamate levels.
Importantly, evenamide has demonstrated high selectivity, showing no significant biological activity across more than 130 other central nervous system targets. This specificity may contribute to its favorable safety and tolerability profile, which is a critical consideration in long-term psychiatric treatment.
Preclinical studies have also revealed synergistic effects when evenamide is combined with subtherapeutic doses of other antipsychotics, including clozapine. These findings suggest that evenamide may enhance the efficacy of existing therapies, particularly in patients who have not responded adequately to standard treatments. Notably, the therapeutic benefits of evenamide appear to persist even after the compound has been metabolized, indicating potential long-lasting effects that could translate into sustained clinical improvements.
Addressing the Unmet Needs of Treatment-Resistant Schizophrenia
Treatment-resistant schizophrenia remains a significant clinical challenge. A substantial proportion of patients with schizophrenia—estimated to be between one-third and one-half—experience inadequate responses to currently available antipsychotic medications. Approximately 15% of patients exhibit treatment resistance from the onset of the disease.
TRS is typically defined as a lack of sufficient symptom improvement despite treatment with at least two different antipsychotics at therapeutic doses for an adequate duration. For these patients, treatment options are extremely limited, and outcomes are often poor, with significant impacts on quality of life, social functioning, and overall prognosis.
Emerging scientific evidence points to abnormalities in glutamate neurotransmission as a key factor underlying treatment resistance. Unlike dopamine dysregulation, which is effectively targeted by existing antipsychotics, glutamatergic dysfunction remains largely unaddressed by current therapies. This insight has fueled interest in developing novel treatments that target glutamate pathways, positioning evenamide as a promising candidate in this space.
Newron’s Broader Vision in Neuroscience
Headquartered in Bresso, near Milan, Newron Pharmaceuticals has established itself as a leader in neuroscience innovation, with a track record of advancing therapies from early discovery through to commercialization. The company’s commitment to addressing unmet medical needs in neurological and psychiatric disorders is reflected in its robust pipeline and strategic partnerships.
Evenamide stands at the forefront of Newron’s development efforts and has the potential to become the first approved add-on therapy specifically targeting treatment-resistant schizophrenia. Clinical data generated to date indicate meaningful improvements in key efficacy measures, with benefits that appear to increase over time. Additionally, the compound has demonstrated a favorable safety profile, distinguishing it from many currently available antipsychotics.
To support global development and commercialization, Newron has established partnerships with regional pharmaceutical companies. These include agreements with EA Pharma, a subsidiary of Eisai Co., Ltd., covering Japan and other Asian markets, as well as collaborations with Myung In Pharm for South Korea.
In addition to evenamide, Newron’s portfolio includes its marketed product Xadago® (safinamide), approved for the treatment of Parkinson’s disease across multiple regions, including the European Union, the United States, Japan, and others. The product is commercialized in partnership with Zambon, while Supernus Pharmaceuticals holds marketing rights in the United States, and Meiji Seika Pharma manages development and commercialization in key Asian territories.
Newron’s participation in SIRS 2026 represents a significant opportunity to showcase its latest research and reinforce its commitment to advancing treatment options for schizophrenia. By presenting new data on evenamide across multiple scientific formats, the company aims to engage with the global research community, foster collaboration, and contribute to the ongoing evolution of psychiatric care.
As the ENIGMA-TRS Phase III program progresses, the data generated could pave the way for regulatory submissions and, ultimately, a new standard of care for patients with treatment-resistant schizophrenia. If successful, evenamide may not only address a critical unmet need but also redefine the therapeutic landscape by introducing a novel mechanism of action centered on glutamatergic modulation.
Through its continued investment in research, strategic partnerships, and scientific engagement, Newron is positioning itself at the forefront of innovation in neuropsychiatry, with the potential to make a lasting impact on the lives of patients worldwide.
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