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Newron Announces Approval for Pivotal Phase III ENIGMA-TRS Program With Evenamide as Add-on Therapy in Patients With Treatment-resistant Schizophrenia (TRS)
MILAN & MORRISTOWN, N.J., May 12, 2025--Newron initiates pivotal Phase III trial for evenamide as add-on therapy in 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/bc1bc78e21390ef1899448d5394ed7d6"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/RYUJcUJohU4L3whWJ9ViaA--/YXBwaWQ9aGlnaGxhbmRlcjt3PTk2MDtoPTU2MjtjZj13ZWJw/https://media.zenfs.com/en/business-wire.com/bc1bc78e21390ef1899448d5394ed7d6","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 1 is an international, one-year, double-blind, placebo-controlled Phase III study in at least 600 patients; enrollment to start imminently; 12-week study results expected in Q4 2026","length":192,"tagName":"p","attribs":{}},{"type":"text","content":"ENIGMA-TRS 2, approved by the US Food and Drug Administration (FDA), is a US-based and international, 12-week, double-blind, placebo-controlled Phase III study in at least 400 patients; study expected to start within the next three months","length":238,"tagName":"p","attribs":{}},{"type":"text","content":"Evenamide has the potential to become the first add-on therapy for patients suffering from TRS and for poorly responding patients with schizophrenia","length":148,"tagName":"p","attribs":{}},{"type":"text","content":"Unique glutamatergic modulation mechanism of action offers new therapeutic option for this patient population","length":109,"tagName":"p","attribs":{}},{"type":"text","content":"MILAN & MORRISTOWN, N.J., May 12, 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 approval for its pivotal ENIGMA-TRS Phase III development program evaluating evenamide as an add-on therapy to current antipsychotics, including clozapine, in patients with treatment-resistant schizophrenia (TRS).","length":517,"tagName":"p"},{"type":"text","content":"The ENIGMA-TRS Phase III development program consists of two pivotal studies, ENIGMA-TRS 1 and ENIGMA-TRS 2. The two studies are expected to meet the ICH (International Council for Harmonisation of Technical Requiremen...