Evenamide for Treatment-Resistant Schizophrenia

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Newron Pharmaceuticals recently announced results from study 014—a phase 2, randomized, open label, trial evaluating evenamide as an add-on to an antipsychotic (excluding clozapine) in patients with treatment-resistant schizophrenia (TRS).

In this study, 161 patients were randomized, 153 completed the 6-week treatment period, and 144 entered the extension study (study 015). The results of the entire study population are consistent with the findings from the first 100 patients at this timepoint.

“The final results of study 014 are exciting for various reasons. Firstly, the results indicate that the last 61 patients to be enrolled in the study share the same demographic and disease improvement characteristics as of the first 100 patients, after 6 weeks of treatment. Treatment with evenamide at all doses (7.5, 15, or 30 mg bid) was also as well tolerated in the final 61 patients as was shown in the initial cohort of 100 patients, thus confirming the reliability of the data collected in this study,” said Ravi Anand, MD, Newron’s chief medical officer.

Additionally, the mean Positive and Negative Syndrome Scale (PANSS) total score, Clinical Global Impression of Severity (CGI-S) rating, and Strauss-Carpenter Level of Functioning (LOF) total score significantly improved compared with baseline (p<0.001). The proportion of patients considered “clinically important responders” on the PANSS, the Clinical Global Impression of Change (CGI-C), and the CGI-S was in line with the proportion of the first 100 patients experiencing this level of benefit after 6 weeks. Mean improvement from baseline was also consistent for the Medication Satisfaction Questionnaire (MSQ) when compared to this measure for the first 100 patients.

Only 26% of patients experienced treatment-emergent adverse events, and none were rated severe. The most commonly reported adverse events (≥3%) were dizziness, pyrexia, and CPK increase. This adverse event profile was like that seen from the first 100 patients.

“We are hopeful that these encouraging results at 6 weeks from all 161 patients in study 014 will be replicated at 6 months and 1-year timepoints in all patients in study 015. Confirmation of these results in the final analyses would offer new hope to patients with TRS and would further support our plans for the initiation of study 003, a phase 3 study in patients with TRS, which we intend to begin later in 2023,” said Anand.

The results from study 014 will be presented at the 36th European College of Neuropsychopharmacology (ECNP) Congress in Barcelona, Spain on October 7-10, 2023.

Reference

1. Newron reports compelling topline results from all patients in Study 014, its Phase II clinical trial evaluating evenamide as add-on therapy for treatment-resistant schizophrenia. Newron. News release. March 20, 2023. Accessed March 22, 2023. https://www.newron.com/news-and-media/regulatory-news/newron-reports-compelling-topline-results-all-patients-study-014-its