Newron's glutamate-targeting evenamide shows promise in schizophrenia study

30 Apr 2024
firstwordpharma.com
Clinical ResultPhase 2Phase 3
Newron Pharmaceuticals announced positive top-line results Tuesday from a Phase II/III study evaluating its experimental drug evenamide (NW-3509) in patients with chronic schizophrenia who are poorly managed on second-generation antipsychotics.
When added to their existing treatment, the oral glutamate-targeting agent led to significant improvements in schizophrenia symptoms, achieving both the primary and secondary endpoints of the potentially pivotal trial. "Glutamatergic inhibition mechanism of action offers an innovative therapeutic option to schizophrenia patients," the company noted.
The study, dubbed 008A, randomised 291 patients to receive either evenamide 30mg twice daily or placebo for four weeks. Newron said its drug demonstrated statistically significant improvements compared to placebo on the primary endpoint of Positive and Negative Syndrome Scale (PANSS).
Specifically, evenamide patients saw a 10.2-point reduction in PANSS total score, compared to a reduction of 7.6 points for placebo. The least square (LS) mean difference was 2.5, the company said. For the key secondary measure of Clinical Global Impression of Severity (CGI-S), the LS mean difference was 0.16 between the evenamide and placebo arms.
Newron said evenamide was also well tolerated, with a high study completion rate. Only three patients discontinued due to adverse events. Overall adverse event rates were similar between the two groups at about 25% each, with no concerning safety signals. Headache, vomiting and nasopharyngitis were the most common side effects seen with evenamide. Details from the study will be disclosed in the coming weeks.
The positive 008A results build on previously reported six-month efficacy data in treatment-resistant schizophrenia (TRS) patients. According to mid-stage results reported late last year, 40% of patients given evenamide no longer met protocol severity criteria used to diagnose treatment resistance. Newron reiterated Tuesday that its next step is to run a potentially pivotal Phase III trial in this patient population.
The 008A readout is the latest effort in the race to develop novel treatments for schizophrenia, a space that has a number of contenders. An FDA decision on KarXT (xanomeline-trospium), a muscarinic receptor agonistmuscarinic receptor agonist acquired by Bristol Myers Squibb, is expected by September 26, while Neurocrine Biosciences' M4 agonist NBI-1117568 is currently in Phase II.
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