Newron Pharmaceuticals has randomised the first participants in its placebo-controlled ENIGMA-TRS 1 Phase III programme of evenamide for treatment-resistant schizophrenia (TRS).
This announcement was made by the company after it completed a screening period for 42 days and a review of subjects by the Independent Eligibility Committee.
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The ENIGMA-TRS 1 is a 52-week, international, double-blind study designed to assess the safety, tolerability and efficacy of 15mg and 30mg twice a day doses of the evenamide as an add-on treatment against a placebo.
The trial will include a minimum of 600 subjects from various trial centres across Asia, Canada, Latin America and Europe.
Subjects eligible for the trial are those currently on second-generation antipsychotics (SGAs), including clozapine, who meet the Treatment Response and Resistance Psychosis (TRRIP) international consensus criteria for the condition.
An Independent Eligibility Assessment Committee (IEAC) will review the patients’ diagnoses, antipsychotic plasma levels, and adherence to the study’s selection criteria.
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By GlobalDataThe primary safety and efficacy evaluation will take place 12 weeks post-randomisation, with the trial maintaining its placebo-controlled and double-blind approach until the end of the 52-week term. The results from the 12-week analysis are expected to be disclosed in the fourth quarter of 2026.
The second study within the company’s pivotal Phase III ENIGMA-TRS programme, ENIGMA-TRS 2, has received approval from the US Food and Drug Administration (FDA).
This will involve at least 400 subjects in a randomised, placebo-controlled, double-blind Phase III trial for 12 weeks, to test the safety, tolerability, and efficacy of the 15mg twice-daily dose of evenamide.
The IEAC will review these subjects as well, with the safety and efficacy analysis scheduled after the 12-week trial period. The initiation of the study at US investigational centres is anticipated to commence this October.
Newron Pharmaceuticals’ chief medical officer Ravi Anand said: “Today’s announcement marks an important milestone for the clinical advancement of evenamide for treatment-resistant schizophrenia patients who urgently need more effective therapeutic options.
“We look forward to advancing evenamide through this pivotal Phase III study and delivering an important benefit to patients in need.”
Last year, evenamide met primary and secondary endpoints in a Phase II/III trial.
