Newron Pharmaceuticals — ENIGMA-TRS 1 commences enrolment

Newron Pharmaceuticals has confirmed that enrolment has begun for its registrational ENIGMA-TRS Phase III programme for lead candidate evenamide. The first of two trials for the programme is ENIGMA-TRS 1, an international, one-year, double-blinded, placebo-controlled, pivotal Phase III study. It aims to enrol 600 patients with treatment-resistant schizophrenia (TRS), and a 12-week readout is anticipated from Q426. Patient enrolment has commenced in line with prior guided timelines, and marks a key milestone for Newron’s lead programme. In parallel, Newron is preparing for the second trial, ENIGMA-TRS 2, which will be a 400-patient international study (including the US). This trial is anticipated to launch by October 2025.