Milan-based Newron Pharmaceuticals shared promising one-year interim efficacy results from its phase 2 trial evaluating evenamide as add-on therapy for patients with treatment-resistant schizophrenia (TRS).
Newron touted results from the first 100 randomized patients who have completed one year of treatment in its international, randomized, open label, rater-blinded study as "highly compelling, statistically significant, clinically meaningful improvement in assessments of symptoms of psychosis, disease severity and global evaluation."
The study (014) and its extension study (015) is testing evenamide as an add-on to an antipsychotic (excluding clozapine) in patients with moderate to severe TRS 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) — a scale used to measure symptom severity — showed more than a 50% increase over the statistically significant benefit noted at the six-week datapoint. Furthermore, 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, says Newron.
Currently, clozapine — first approved back in 2004 — is the treatment of choice for the management of TRS. However, according to Jean-Pierre Lindenmayer, director of research at Nathan Kline Institute for Psychiatric Research at Manhattan Psychiatric Center, "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."
Newron says patient enrollment in study 014 is complete, with 161 subjects randomized. The company anticipates announcing the full results from the study in March 2023. The extension study 015 is ongoing and is expected to provide results of evenamide treatment for up to one year from all patients by 2024.
