Newron Initiates Phase III ENIGMA-TRS Study for Treatment-Resistant Schizophrenia

Newron Pharmaceuticals S.p.A. has commenced enrollment for its pivotal Phase III ENIGMA-TRS program. This study focuses on evenamide as an add-on therapy for patients with treatment-resistant schizophrenia (TRS). Conducted over a year, this international, double-blind, placebo-controlled trial plans to involve at least 600 patients. Initial study results are anticipated in Q4 2026.

Evenamide is noted as a first-in-class glutamate modulator. It presents a novel therapeutic option for TRS patients who remain unresponsive to current antipsychotics. The drug's glutamatergic modulation mechanism is unique and may benefit patients poorly responding to existing treatments.

The ENIGMA-TRS 1 study will assess the efficacy and safety of evenamide, using both 15mg and 30mg doses, alongside second-generation antipsychotics, including clozapine. Newron aims to demonstrate evenamide's potential, previously indicated in earlier trial phases, and further advance towards providing a new solution for TRS patients.