Newron Pharmaceuticals’ Evenamide could be a potential breakthrough treatment in the management of treatment-resistant schizophrenia (TRS) patients, according to new trial data.
The drug is being assessed as an add-on to an antipsychotic (excluding clozapine) in patients with moderate to severe TRS who are not responding to their current antipsychotic medication.
The efficacy results, based on changes over baseline at one year in the Positive and Negative Syndrome Scale (PANSS), showed more than a 50% increase over the statistically significant benefit noted at the six-week datapoint.
The proportion of patients experiencing a clinically meaningful PANSS improvement at one year was almost three times higher than the proportion responding at week six.
In addition, the proportion of patients who experienced highly meaningful (at least two categories) improvement in the severity of disease as assessed by the Clinical Global Impression of Severity (CGI-S) more than doubled compared to the proportion of patients improving at week six.
The results are from the first 100 randomised patients who have completed one year (52 weeks) of treatment.
Very promising results
Jean-Pierre Lindenmayer, Director of Research, Psychopharmacology Research Unit – Nathan Kline Institute for Psychiatric Research at Manhattan Psychiatric Center, commented: “Clozapine is the treatment of choice for the management of treatment-resistant schizophrenia (TRS). However, more than half of patients with TRS do not respond to clozapine, which makes it extremely urgent to find new and effective treatments for TRS.
“These Phase II, open-label data of evenamide in patients with TRS, obtained with blinded raters, are very promising. The pattern of improvement is particularly unusual as it occurs gradually over a year and is sustained. We rarely see such a pattern of improvement with current treatments. In addition, the mechanism of action of evenamide appears to be completely novel, which may open up new pathways for treatment for TRS. Of course, these results need to be confirmed by a planned randomised, placebo-controlled study in TRS patients.”
Ravi Anand, Newron’s Chief Medical Officer, added: “These results validate the role of this glutamate release inhibitor in repairing disturbed neural connectivity in a treatment-refractory patient population and should help us to expedite the start of our placebo-controlled Phase III study in patients with TRS that we plan in 2023.”