The FDA has halted U.S. enrollment for Newron Pharmaceuticals’ phase 3 schizophrenia trial, following the death of a patient outside of the country.
The ENIGMA-TRS 2 study is testing evenamide, a small molecule that blocks sodium channels, as an adjunctive therapy for patients with treatment-resistant schizophrenia. The patient’s death was sudden and deemed unrelated to treatment, Newron said in an April 29 release.
When Newron informed the independent safety monitoring board about the death, the board concluded the study—which plans to enroll around 400 patients across the U.S., Argentina, India and other countries—should continue as planned, the company said.
Newron has another ongoing phase 3 trial of evenamide, ENIGMA-TRS 1, that is recruiting patients in Europe, Canada, Latin America and Asia.
“The board has been informed of the event and has concluded that the studies should continue as designed,” Newron’s Chief Medical Officer Ravi Anand, M.D., said in the release. “In the evenamide development program, to date, there is no increase in the risk of mortality between evenamide and placebo-treated patients based on the duration of treatment. Sudden death is not uncommon in patients with schizophrenia.”
Related
People with schizophrenia are significantly more likely than others their age to die suddenly from a range of causes, including heart attacks, pneumonia and airway obstruction.
Milan, Italy-based Newron licensed some rights to evenamide in Asia to a subsidiary of Eisai in late 2024, netting an upfront payment of $46.1 million. The subsidiary, EA Pharma, holds the rights to develop, manufacture and market the drug candidate in Japan, and other designated Asian territories, including Vietnam and Indonesia.
Evenamide posted positive results from a phase 2/3 study back in 2024, with Newron holding out hope at the time that it would secure approval for the first new schizophrenia drug in decades. The biotech ultimately lost that race to Bristol Myers Squibb, which snagged an approval in 2024 for Cobenfy, the prize of a $14 billion buyout of Karuna Therapeutics.
