Newron Completes Screening for Pivotal Phase 3 ENIGMA-TRS 1 Study with Evenamide

Newron Pharmaceuticals has finalized the screening for enrollment in its Phase 3 ENIGMA-TRS 1 study. This trial assesses evenamide as an add-on therapy for patients with treatment-resistant schizophrenia (TRS). The international study involves more than 600 patients and aims to provide new treatment options through a glutamate modulating mechanism. Efforts are currently focused on completing the target enrollment, with results from the initial 12-week treatment period expected in the first quarter of 2027.

As of now, 996 patients have been screened and 411 have been randomized for treatment. The study is anticipated to meet its goal of enrolling 600 patients, with more participants undergoing the screening process. The ENIGMA-TRS 1 study is designed to evaluate the efficacy, tolerability, and safety of evenamide compared to placebo, with particular attention to the Positive and Negative Syndrome Scale scores.