Newron Pharmaceuticals SpA ((NWPHF)) announced an update on their ongoing clinical study.
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Study Overview: Newron Pharmaceuticals SpA is conducting a Phase III study titled Evenamide, a Glutamate Release Modulator, as Add-On to Standard of Care in Subjects With Documented Treatment-Resistant Schizophrenia. The study aims to assess the efficacy, safety, and tolerability of Evenamide as an additional treatment for patients with treatment-resistant schizophrenia who do not respond adequately to their current antipsychotic medications.
Intervention/Treatment: The study tests Evenamide, a glutamate release modulator, administered at a dose of 15 mg twice daily. It is intended to enhance the therapeutic effects of existing antipsychotic treatments in patients with treatment-resistant schizophrenia.
Study Design: This is a 12-week, randomized, double-blind, placebo-controlled study with a parallel-group design. Participants are randomly assigned to receive either Evenamide or a placebo, with masking applied to participants, care providers, investigators, and outcomes assessors. The primary purpose is treatment-focused.
Study Timeline: The study is set to begin recruiting on September 18, 2025, with the latest update submitted on September 25, 2025. These dates are crucial for tracking the study’s progress and ensuring timely updates for stakeholders.
Market Implications: This study could significantly impact Newron Pharmaceuticals’ stock performance, as successful results may enhance investor confidence and market position. The study’s outcome could also influence the competitive landscape in the treatment-resistant schizophrenia market, potentially affecting other companies developing similar treatments.
The study is ongoing, with further details available on the ClinicalTrials portal.