Newron Pharmaceuticals Updates on FDA Clinical Hold and ENIGMA-TRS Study

Newron Pharmaceuticals has received a written update from the FDA regarding the clinical hold on the ENIGMA-TRS 2 study at U.S. sites. The hold arises from concerns about evenamide, a drug under investigation, which could cause arrhythmias. Newron is reviewing the feedback and plans to respond after completing a comprehensive analysis.

Enrollment for ENIGMA-TRS 1 is expected to conclude by mid-October, with results anticipated in early 2027. Meanwhile, ENIGMA-TRS 2 continues internationally as planned. The FDA raised concerns after observing four deaths among evenamide-treated patients, a potential safety issue noted by the agency. Of these, three were deemed unrelated to the drug by investigators, while one lacked a definitive cause.

The company remains committed to addressing safety concerns and advancing the development of evenamide for treatment-resistant schizophrenia, citing no observed pattern of cardiac issues in their analyses so far.