FDA keeps Newron’s evenamide trial on hold in U.S.
Newron Pharmaceuticals will expand its Phase 3 evenamide trial outside the U.S. after the FDA decided to maintain a hold on enrollment at American sites.
Why it matters: The decision comes shortly after the Italian biotech said it expected U.S. enrollment in ENIGMA-TRS 2 to resume “in the near future.” Newron is testing evenamide as an add-on treatment for people with treatment-resistant schizophrenia.
Backstory: The FDA imposed the hold in April after Newron reported the sudden death of a study participant at a site outside the U.S. The investigator assessed the death as unrelated to treatment, and an independent safety board recommended that the studies continue. No U.S. patients had received evenamide in ENIGMA-TRS 2.
Zoom in: Enrollment continues outside the U.S., and Newron plans to add sites in Europe, Asia and Latin America. About 80 people have entered screening for ENIGMA-TRS 2, which aims to enroll at least 400 patients. Newron said it is awaiting a written FDA communication explaining the decision and any further protocol changes needed to lift the hold.
- The company’s separate, 600-patient ENIGMA-TRS 1 trial continues, with results from its 12-week primary assessment expected in the first quarter of 2027. Newron secured up to €38 million in February to advance the two pivotal studies.
What to watch: The FDA’s written response should clarify what Newron must do to restart U.S. enrollment.
