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Newron Announces the US Initiation of Its ENIGMA-TRS 2 Phase III Global Clinical Study With Evenamide as an Add-On Therapy for Patients With Treatment-Resistant Schizophrenia (TRS)
MORRISTOWN, N.J. & MILAN, December 08, 2025--Newron announces US initiation of its ENIGMA-TRS 2 Phase III global study of evenamide for patients with treatment-resistant schizophrenia (TRS).
About this update from Newron Pharmaceuticals S.p.a.
[{"type":"image","alt":"","displaySize":"","headline":null,"caption":"","credit":null,"className":"","disableSlideshowImg":false,"size":{"original":{"width":480,"height":281,"url":"https://media.zenfs.com/en/business-wire.com/66e28cf681c03f94a735098f9867c218"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/CFftm10UGgsn_99gH4nedw--/YXBwaWQ9aGlnaGxhbmRlcjt3PTk2MDtoPTU2MjtjZj13ZWJw/https://media.zenfs.com/en/business-wire.com/66e28cf681c03f94a735098f9867c218","width":480,"height":281}},"lazy":false},{"type":"text","content":"Ad hoc announcement pursuant to Art. 53 LR","length":42,"tagName":"p","attribs":{}},{"type":"text","content":"ENIGMA-TRS 2 is a global, randomized, double-blind, placebo-controlled 12-week Phase III clinical study designed to enroll at least 400 patients; topline results are expected by Q4 2026","length":185,"tagName":"p","attribs":{}},{"type":"text","content":"Evenamide is a first-in-class glutamate modulator with a novel mechanism of action for patients who do not respond adequately or are resistant to existing antipsychotic therapies","length":178,"tagName":"p","attribs":{}},{"type":"text","content":"Newron’s ENIGMA-TRS program (ENIGMA-TRS 1, started in August 2025, and ENIGMA TRS 2) aims to establish evenamide as the first approved add-on therapy for TRS, providing a new treatment option for a patient population with high morbidity and mortality","length":250,"tagName":"p","attribs":{}},{"type":"text","content":"MORRISTOWN, N.J. & MILAN, December 08, 2025--(BUSINESS WIRE)--Newron Pharmaceuticals S.p.A. ("Newron") (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced the initiation of its ENIGMA-TRS 2 Phase III clinical study in the US, following approvals from the US Food and Drug Administration (FDA) and the Institutional Review Board (IRB). The first site to initiate the study will be the Semel Translational Research Center for Neuropsychiatry (TRCN), University of California, Los Angeles (UCLA). The remaining US sites participating in ENIGMA-TRS 2 are expected to initiate the study shortly. Regulatory submissions are currently being made in the other countries that are expected to participate in this trial in the coming months.","length":880,"tagName":"p"},{"type":"text","content"...