Newron Completes Enrollment of Pivotal Phase 3 ENIGMA-TRS 1 Study

Total of 618 patients randomized

Topline 12-week data expected in Q1 2027

MILAN and MORRISTOWN, N.J., Oct. 22, 2026 (GLOBE NEWSWIRE) -- 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 that it has completed enrollment in the pivotal Phase 3 ENIGMA-TRS 1 study evaluating evenamide, its proprietary investigational first-in-class glutamate modulator, as a potential first add-on therapy to second-generation antipsychotics in patients meeting established international consensus criteria for treatment-resistant schizophrenia (TRS). A total of 618 patients have been enrolled at more than 80 study centers in 19 countries across Europe, Asia, Latin America and Canada.

Newron expects to disclose topline 12-week data in Q1 2027. The study will continue under double-blind, placebo-controlled conditions through 52 weeks.

“Reaching this important milestone in the ENIGMA-TRS 1 study reflects the tremendous commitment of investigators and clinical teams, alongside the close collaboration of our academic and regulatory partners, as well as the patients and their families. The study is particularly important given the complexity of conducting a first long-term, randomized, double-blind, placebo-controlled add-on study in patients with TRS, an area of considerable unmet medical need.”

“Of the 996 patients who entered screening, 618 were found to be eligible for the study and were randomized to receive evenamide at 15 mg or 30 mg twice daily, or placebo, following strict adherence to the eligibility criteria by the Independent Eligibility Assessment Committee and five CRO psychiatrists. We look forward to continuing working closely with the investigators and their teams towards successful completion of the study”, said Ravi Anand, MD, Chief Medical Officer of Newron.

Evenamide targets the modulation of excessive release of glutamate in patients suffering from treatment-resistant schizophrenia (TRS).

About ENIGMA-TRS

ENIGMA-TRS 1 is an ongoing, international, 52-week, randomized, double-blind, placebo-controlled Phase 3 study evaluating the efficacy, tolerability, and safety of the 15mg BID and 30mg BID therapeutic doses of evenamide compared to placebo. Patients on second-generation antipsychotics, including clozapine, were required to meet Treatment Response and Resistance Psychosis international consensus criteria for TRS. The study has completed enrollment, with a total of 618 patients enrolled at study centers in 19 countries in Europe, Asia, Latin America, and Canada.

The primary assessment of efficacy and safety of ENIGMA-TRS 1 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. Newron expects to announce results from the 12-week primary endpoint assessment in Q1 2027.

ENIGMA-TRS 2 is enrolling patients at study centers in Asia and Latin America, with additional sites planned in Europe. The study uses the same screening procedure as ENIGMA-TRS 1. ENIGMA-TRS 2 will include at least 400 patients in a 12-week, randomized, double-blind, placebo-controlled Phase 3 study, designed to evaluate the efficacy, tolerability, and safety of the 15mg BID dose of evenamide compared to placebo. The efficacy and safety analysis will be performed at the 12-week point following successful completion of the study. The FDA clinical hold remains in place at U.S. study centers, where no patients have received evenamide.

About Newron Pharmaceuticals

Newron (SIX: NWRN, XETRA: NP5) is a biopharmaceutical company focused on the development of innovative therapies for patients with diseases of the central and peripheral nervous system. Headquartered in Bresso near Milan, Italy, the Company has a strong track record of advancing neuroscience-based treatments from discovery to market. Newron’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. Evenamide is currently being developed in the global pivotal ENIGMA-TRS Phase 3 program. Clinical trial results to date demonstrate the benefits of this drug candidate in TRS as well as in 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. Newron’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. For more information, please visit: https://www.newron.com and connect with us on LinkedIn.

For more information, please contact:

Newron
Stefan Weber – CEO; pr@newron.com

UK/Europe
Simon Conway / Ciara Martin / Natalie Garland-Collins, FTI Consulting; +44 20 3727 1000, SCnewron@fticonsulting.com

Switzerland
Valentin Handschin, IRF; +41 43 244 81 54, handschin@irf-reputation.ch

Germany/Europe
Anne Hennecke / Maximilian Schur, MC Services; +49 211 52925227, newron@mc-services.eu

USA
John Fraunces, LifeSci Advisors; +1 917 355 2395, jfraunces@lifesciadvisors.com

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