Newron Pharmaceuticals — Phase III ENIGMA-TRS 2 trial underway

Newron Pharmaceuticals has announced the launch of its Phase III ENIGMA-TRS 2 trial in the US, marking an important step for the registrational programme for lead candidate evenamide in treatment-resistant schizophrenia (TRS). ENIGMA-TRS 2 is a global, randomised, double-blind, placebo-controlled, 12-week pivotal study designed to enrol c 400 TRS patients. Topline results are anticipated by Q426, at a similar time to the ENIGMA-TRS 1 trial, representing a highly important inflection point for Newron. Additional US sites for ENIGMA-TRS 2 are due to initiate shortly and regulatory submissions are being made to other countries expected to participate in this trial.