Newron's ENIGMA-TRS Phase III Program Approved for Treatment-Resistant Schizophrenia

Newron Pharmaceuticals S.p.A. has received approval for its pivotal Phase III ENIGMA-TRS program, focusing on evenamide as an add-on treatment for patients with treatment-resistant schizophrenia (TRS). The program includes two key studies: the international ENIGMA-TRS 1 with 600 patients over a year and ENIGMA-TRS 2 in the US with 400 patients over 12 weeks. Both are designed to evaluate the efficacy and safety of evenamide when combined with current antipsychotics.

The drug's unique glutamatergic modulation offers possible benefits for TRS patients, potentially making it the first targeted add-on therapy for this condition. Enrollment for the studies is set to begin imminently, with initial results expected by late 2026.