Newron Faces U.S. FDA Hold in ENIGMA-TRS 2 Study

MILAN and MORRISTOWN, N.J., Sept. 25, 2026 /CourierPR/ -- Newron Pharmaceuticals, a biopharmaceutical company focused on developing novel therapies for patients with diseases of the central and peripheral nervous system, has announced an update on its Phase 3 ENIGMA-TRS 2 study. The U.S. Food and Drug Administration (FDA) has informed Newron that the hold on the enrollment of new patients will remain in place at U.S. sites. However, the study continues in all other countries.

The company is initiating the expansion of clinical sites and enrollment for ENIGMA-TRS 2 in Europe, Asia, and Latin America. To date, approximately 80 patients have entered screening, and the study aims to enroll at least 400 patients following the successful completion of the 42-day screening period.

ENIGMA-TRS 1, the ongoing international 52-week, randomized, double-blind, placebo-controlled Phase 3 study, is currently enrolling patients in 20 countries, including Europe, Asia, Latin America, and Canada. By mid-October 2026, at least 600 patients are expected to have enrolled in the study. The primary assessment of efficacy and safety will be performed 12 weeks after randomization to treatment. Following this initial period, the study will continue to be double-blind and placebo-controlled until the 26- and 52-week time points. The primary efficacy endpoint of the trial will be the change from baseline in the Positive and Negative Syndrome Scale (PANSS) scores at 12 weeks.

ENIGMA-TRS 2, which is taking place at centers in the U.S. and selected additional countries, will include at least 400 patients in a 12-week, randomized, double-blind, placebo-controlled Phase 3 study. The study is designed to evaluate the efficacy, tolerability, and safety of the 15mg BID dose of evenamide compared to placebo. In December 2025, ENIGMA-TRS 2 was initiated in the U.S., following approvals from the FDA and the Institutional Review Board (IRB). The efficacy and safety analysis will be performed at the 12-week point following the successful completion of the study. On April 29, 2026, Newron reported a hold by the FDA on the enrollment of new patients in the U.S. sites of the study, following Newron’s notification to the agency of the sudden unexpected death of a study participant at a clinical site outside the United States. The investigator assessed the event as unrelated to study treatment. Newron has informed the independent international safety monitoring board for the overall ENIGMA-TRS program, which has reviewed the event and recommended that the studies continue as designed.

The company's lead compound, evenamide, is a first-in-class glutamate modulator and has the potential to be the first add-on therapy for treatment-resistant schizophrenia (TRS) and for poorly responding patients with schizophrenia. Clinical trial results to date demonstrate the benefits of this drug candidate in TRS as well as poorly responding patient populations, with significant improvements across key efficacy measures increasing over time, as well as a favorable safety profile, which is uncommon for available antipsychotic medications.

Newron has signed development and commercialization agreements for evenamide with EA Pharma (a subsidiary of Eisai) for Japan and other Asian territories, as well as Myung In Pharm for South Korea. The company's first marketed product, Xadago®/safinamide, has received marketing authorization for the treatment of Parkinson's disease in the European Union, Switzerland, the UK, the USA, Australia, Canada, Latin America, Israel, the United Arab Emirates, Japan, and South Korea. The product is commercialized by Newron's partner Zambon, with Supernus Pharmaceuticals holding marketing rights in the U.S., and Meiji Seika responsible for development and commercialization in Japan and other key Asian territories.