Newron Pharmaceuticals has received written communication from the FDA in regard to the clinical hold of its phase 3 study for evenamide on patients with schizophrenia, following the death of four patients.
The FDA’s concern relates to the known risk that certain members of the class of sodium channel blockers may trigger arrhythmias which in turn can lead to serious cardiovascular events or seizures. Evenamide is a glutamate modulator via its action as a selective voltage-gated sodium channel blocker. The company had to halt its phase 3 ENIGMA-TRS development program in U.S. study centers after four patients who received the oral drug in clinical studies died along with one patient who was receiving a placebo. Although three of the deaths in patients taking evenamide were determined to be unrelated to the drug, one is “possibly related” due to two autopsies being unable to definitively declare the cause of death.
Newron is reviewing the FDA feedback and preparing a response. It still expects to complete enrollment for the ENIGMA-TRS 1 trial by mid-October and have topline 12-week data by Q1 2027. It is also continuing enrollment outside the country for ENIGMA-TRS 2.