Newron charts course forward for stalled schizophrenia drug

 Newron Pharmaceuticals thinks it may have reached an agreement with the FDA on a way to get the development of its schizophrenia candidate evenamide back on track, after it was placed under a clinical hold earlier this year.

The Italy-headquartered company said it has held a meeting with the FDA that discussed changes to the ENIGMA-TRS 2 trial of evenamide in treatment-resistant schizophrenia that could allow US patient enrolment to start again.

In April, the FDA placed a block on recruitment into ENIGMA-TRS 2 in the US after a sudden death in an overseas study subject, despite Newron's protestations that the fatality appeared to be unrelated to the drug treatment and against the conclusions of the trial's independent safety monitoring board that it should continue as planned.

When the FDA announced its clinical hold, Newron's chief medical officer, Ravi Anand, said: "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."

He added: "Sudden death is not uncommon in patients with schizophrenia."

In its new statement, Newron said: "The face-to-face meeting was constructive, and the parties discussed potential actions toward the resolution of issues that led to the hold. Newron, as agreed with the agency, plans to propose changes to address the agency's concerns" that may allow it to consider restarting enrolment, it added.

Evenamide is a glutamate modulator acting on sodium channels that Newron hopes could become the first add-on therapy for treatment-resistant schizophrenia and for patients with schizophrenia who can't control their symptoms using current atypical antipsychotic drugs.

ENIGMA-TRS 2 is designed to enrol around 400 patients in the US and other countries, and Newron is also running another international study, ENIGMA-TRS 1, which is recruiting around 600 subjects in Europe, Canada, Latin America, and Asia, due to generate results before the end of the year.

Evenamide has had a long route through clinical development – the FDA previously delayed the start of phase 2/3 testing with a query about safety data from animal studies – but Newron has high hopes for the programme, given the limited improvement in schizophrenia treatment in recent decades.

That optimism is shared by analysts at Edison, who wrote in a research note last year – albeit ahead of the FDA hold – that it was modelling 2034 sales of €1.7 billion ($1.95 billion) for the drug in the US, Europe, and Japan, assuming it launches in 2028.

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