Newron Prescribed drugs introduced the approval of the pivotal ENIGMA-TRS part 3 growth program evaluating evenamide as an add-on remedy to present antipsychotics, together with clozapine, in sufferers with treatment-resistant schizophrenia (TRS). This part 3 growth program consists of two pivotal research: ENIGMA-TRS 1 and ENIGMA-TRS 2.1
“Newron vastly appreciates the regulatory approval of the ENIGMA-TRS trials. The optimistic outcomes of evenamide noticed in scientific research and demonstrated in illness fashions have led to excessive enthusiasm in investigators to take part on this landmark program,” mentioned Ravi Anand, MD, the chief medical officer of Newron.
ENIGMA-TRS 1 is a world, 52-week, randomized, double-blind, placebo-controlled phae 3 research evaluating the efficacy, tolerability, and security of the 15 mg BID and 30 mg BID therapeutic doses of evenamide in contrast with placebo. Sufferers on second-generation anti-psychotics (SGAs), together with clozapine, will meet Remedy Response and Resistance Psychosis (TRRIP) worldwide consensus standards for TRS. ENIGMA-TRS 1 will enroll not less than 600 sufferers at research facilities in Europe, Asia, Latin America, and Canada. Individuals will bear a 42-day screening interval, throughout which their TRS prognosis, antipsychotic plasma ranges (background treatment), and conformance to protocol choice standards can be evaluated by an Impartial Eligibility Evaluation Committee (IEAC) of three main worldwide schizophrenia consultants. The first evaluation of efficacy and security can be carried out 12 weeks after randomization to therapy. The research will proceed double-blind and placebo-controlled till the 52-week time level. Enrollment for the research will begin imminently. The 12-week outcomes from the research are anticipated in late 2026.
“The upcoming initiation of ENIGMA-TRS 1 research of evenamide is a major milestone within the seek for new drugs to deal with this devastating situation. Evenamide’s modulation of glutamate, good tolerability, and efficacy in research carried out thus far, each in sufferers who’re poor responders or therapy proof against SGAs, suggests its therapeutic potential in sufferers with TRS. The sector eagerly appears to be like ahead for outcomes from this landmark trial,” mentioned Stephen Marder, MD, distinguished professor of Psychiatry on the Semel Institute of Neuroscience & Human Conduct, and director of the Part on Psychosis on the UCLA Neuropsychiatric Institute.
ENIGMA-TRS 2 is a 12-week, randomized, double-blind, placebo-controlled part 3 research, designed to guage the efficacy, tolerability, and security of the 15 mg BID dose of evenamide in not less than 400 individuals. As in ENIGMA-TRS 1, individuals will meet choice standards and be reviewed by the IEAC. The evaluation for dedication of efficacy and security can be carried out after sufferers full 12 weeks of participation within the trial. ENIGMAS-TRS 2 can be carried out at facilities within the US and different extra international locations. US investigational facilities are anticipated to provoke the research throughout the subsequent 3 months.
“Evenamide’s selectivity for sodium channels and consequent modulation of glutamate, the demonstration of its efficacy in a number of animal fashions of psychosis in addition to the MAM mannequin of neurodevelopmental abnormalities, suggests promising leads to sufferers with TRS. Accomplished research in insufficient responders to SGAs and the outcomes of a one-year research in sufferers with TRS predict therapeutic advantage of evenamide in TRS sufferers,” mentioned Jean-Pierre Lindenmayer, MD, director of Analysis in Psychopharmacology Analysis Unit on the Nathan Kline Institute for Psychiatric Analysis at Manhattan Psychiatric Heart. “Evenamide has the potential to fill a large hole in our therapy for sufferers with incomplete response to SGAs, together with clozapine. I sit up for collaborating to the ENIGMA-TRS 2 trial as a research middle.”
Outcomes from earlier part 2 (research 014/015)2 and part 3 (research 008A)3 research have demonstrated evenamide’s important and growing efficacy as an add-on remedy on a number of measures of psychopathology in sufferers with TRS and insufficient responders, respectively. Evenamide has additionally demonstrated a positive security and tolerability profile.
References
1. Newron proclaims approval for pivotal part III ENIGMA-TRS program with evenamide as add-on remedy in sufferers with treatment-resistant schizophrenia (TRS). Information launch. Enterprise Wire. Could 12, 2025. https://www.businesswire.com/information/house/20250512167812/en/Newron-Broadcasts-Approval-for-Pivotal-Section-III-ENIGMA-TRS-Program-With-Evenamide-as-Add-on-Remedy-in-Sufferers-With-Remedy-resistant-Schizophrenia-TRS
2. Information from Newron’s research 014/015 and an evenamide scientific growth outlook offered on the 2024 Annual Congress of the Schizophrenia Worldwide Analysis Society (SIRS). Information launch. April 8, 2024. Accessed Could 12, 2025. https://www.newron.com/news-and-media/regulatory-news/data-newrons-study-014015-and-evenamide-clinical-development-outlook
3. Newron proclaims optimistic top-line outcomes from probably pivotal Section II/III research 008A with evenamide in schizophrenia sufferers. Information launch. April 30, 2024. Accessed Could 12, 2025. https://www.newron.com/news-and-media/regulatory-news/newron-announces-positive-top-line-results-potentially-pivotal-phase
