Sparks - Newron Pharmaceuticals

Newron has completed enrolment in its Phase III ENIGMA-TRS 1 study of evenamide in treatment resistant schizophrenia (TRS), randomising 618 patients against a minimum target of 600. Top-line efficacy data from the primary 12-week assessment remain expected in Q127. The separate ENIGMA-TRS 2 study remains subject to an FDA clinical hold at US sites.

Of the 996 patients screened, 618 met the strict eligibility criteria, with recruitment spanning more than 80 centres across 19 countries. Evenamide is designed to modulate excessive glutamate release in the brain and is being evaluated alongside existing antipsychotics, including clozapine, in patients inadequately served by current treatments. Participants were randomised to receive evenamide at 15mg or 30mg twice daily, or placebo, with the primary endpoint measuring changes in schizophrenia symptom severity using the Positive and Negative Syndrome Scale (PANSS) at 12 weeks. The trial will remain blinded and placebo controlled through 52 weeks, allowing assessment of longer-term efficacy and safety.

Meanwhile, ENIGMA-TRS 2 continues recruiting outside the US, targeting at least 400 patients, with additional European sites planned. Completion of enrolment removes a key execution hurdle for ENIGMA-TRS 1, placing the Q127 efficacy readout and resolution of the outstanding US regulatory concerns firmly in investor focus.