The NCE’s developer has announced that it is now initiating phase 3 studies.
A study of a new chemical entity (NCE) for treatment-resistant schizophrenia (TRS) found that 40% of patients improved to the point of no longer meeting TRS severity criteria after 6 months of treatment.
Study 014/015—a 6-week, randomized, rater-blinded study by Newron Pharmaceuticals—evaluated the safety, tolerability, and efficacy of evenamide, an investigational NCE for the management of TRS. For study 014, investigators recruited a total of 161 patients with TRS who were consistently administered a therapeutic dose of a single antipsychotic medication, excluding clozapine, with the primary aim of assessing the safety and tolerability of orally administered evenamide at 3 predefined doses: 7.5 mg, 15 mg, and 30 mg twice a day.1
Preliminary efficacy was evaluated by observing changes in Positive and Negative Syndrome Scale (PANSS) scores from baseline. Secondary objectives involved the evaluation of alterations from baseline in Clinical Global Impression of Change (CGI-C), Severity of Illness (CGI-S), and Strauss-Carpenter Level of Functioning (LOF) scale scores.1
Study 015 served as an extension of study 014 to investigate the long-term advantages of inhibiting glutamate release, continuing with 77 patients successfully completing 1 year of treatment with evenamide.1
Results from study 014/015 showed a statistically significant improvement in PANSS, CGI-S, and LOF scores at 6 months (p-value < 0.001: paired t-test, LOCF). A considerable proportion of participants who experienced a > 20% reduction in symptoms compared to baseline on PANSS total score at week 6 had maintained their response upon reevaluation at month 6. No participants experienced a worsening of psychosis, and no participants relapsed. And approximately 40% of participants no longer met the protocol severity criteria used to diagnose treatment resistance upon reevaluation at 6 months.1
These results were recently presented at the 36th European Clinical Neuropsychopharmacology Congress (ECNP) in Barcelona, Spain.1
“These highly encouraging results from study 014/015…demonstrate the potential benefits of evenamide and its unique glutamatergic mechanism of action,” said Ravi Anand, Newron chief medical officer, in a press release. “The findings show that the addition of this glutamate modulation to first- and second-generation antipsychotics in patients with TRS potentiates their effects on dopamine dysfunction and can potentially produce a beneficial antipsychotic response.
“What is remarkable about the effect of evenamide in this study is that treatment benefits continue to accrue overtime, and many patients who do not respond early achieve clinically important benefits later. Importantly, over the course of the study period, we found that no patients relapsed or experienced worsened psychosis, and a significant portion of patients improved to the point that they no longer met the criteria to enroll in the study to begin with.”1
Given these results, Newron has announced that it is moving into phase 3 studies of evenamide for the same indication. According to Anand, “Following these encouraging results, which have been assessed by our international advisory committee, we are preparing to initiate a potentially pivotal, phase 3, multinational, randomized, double-blind, placebo-controlled trial in patients with TRS and are confident that the results from that study will endorse the use of evenamide as an adjunct treatment to any other antipsychotic as a new therapeutic strategy for TRS.”1
Stay up-to-date on news related to research on promising new treatments for treatment-resistant schizophrenia and a wide variety of other psychiatric disorders at psychiatrictimes.com.
Note: Assistance from ChatGPT was used in the preparation of this article.
1. Newron TRS study 6 months’ results: evenamide substantially improves patients to an extent that they no longer meet protocol entry criteria. BusinessWire. October 9, 2023. Accessed October 9, 2023. https://www.businesswire.com/news/home/20231009265107/en/Newron-TRS-Study-6-Months%E2%80%99-Results-Evenamide-Substantially-Improves-Patients-to-an-Extent-That-They-No-Longer-Meet-Protocol-Entry-Criteria