Newron Completes Enrollment for Phase 3 ENIGMA-TRS 1 Study

Newron Pharmaceuticals has successfully completed enrollment for its pivotal Phase 3 ENIGMA-TRS 1 study. This study tests evenamide, a proprietary glutamate modulator, as an add-on therapy for treatment-resistant schizophrenia (TRS). With 618 patients enrolled across 19 countries, the study aims to address a key unmet need for TRS treatment.

Topline data from this 12-week, randomized, double-blind, placebo-controlled study is expected in the first quarter of 2027. Evenamide is being evaluated with 15 mg or 30 mg doses taken twice daily. The study will continue with a 52-week assessment under similar controls.

ENIGMA-TRS 2, a similar study, is underway in Asia and Latin America, following identical screening processes. The results of these trials are anticipated to provide significant insights into the efficacy and safety of evenamide for TRS patients.