Evenamide added to antipsychotic improves treatment-resistant schizophrenia

Key takeaways:

• Compared with antipsychotics alone, the addition of evenamide improves treatment-resistant schizophrenia at 6 months.
• Evenamide was well-tolerated and had few treatment-emergent adverse events.

People with treatment-resistant schizophrenia experienced improvement with evenamide added to antipsychotics compared with antipsychotics alone, according to results from a 6-week trial.

Two posters sharing the findings were presented at the European Congress of Psychiatry in Paris.

Ravi Anand, MD, chief medical officer of Newron Pharmaceuticals, based in Italy, and colleagues enrolled participants with treatment-resistant schizophrenia in a phase 2 trial of evenamide. Participants were randomly assigned to receive 7.5 mg, 15 mg or 30 mg of evenamide twice daily for up to 1 year. For analyses, Anand and colleagues included the first 100 participants who reached 6 months.

Scores on the Clinical Global Impression – Severity (CGI-S) and the Positive and Negative Syndrome Scale (PANSS) improved significantly from baseline to 6 months (both P < .001), according to the first poster. Analyses showed that, based on PANSS, the responder rate at 6 months was 39.2%. Additionally, CGI-S decreased from 4.6 to 3.7, a decrease of 0.9.

Scores on the CGI-Change (CGI-C) revealed that most (84.6%) participants at least “minimally improved,” according to the first poster.

“However, a widely accepted definition of response in patients with treatment-resistant schizophrenia treated with a putative antipsychotic added to their background antipsychotic monotherapy is not currently available, and more work is needed on this highly relevant topic,” researchers wrote in the second poster.

To address this, Anand and colleagues characterized participants who responded to treatment. Specifically, the researchers defined a full response as a PANSS score improvement of at least 20% and a CGI-C of at least “much improved,” as well as at least a one-point improvement on the CGI-S and a CGI-S score of 3 or less. “Partial responders” were defined as those who had a PANSS improvement of 15% or more, any improvement on the CGI-C and at least a one-point improvement on the CCI-S.

“The proportion of patients on evenamide meeting these ‘full’ or ‘partial responder’ definitions increased over time, reaching 26.8% and 24.7%, respectively, at 6 months,” the researchers wrote in the second poster.

References:

• Anand R, et al. Evenamide, as an add-on to antipsychotics, benefits patients with treatment resistant schizophrenia (TRS): 6-month interim results from the first 100 patients in an ongoing international randomized study. Presented at: European Congress of Psychiatry; March 25-28, 2023; Paris.
• Anand R, et al. Characterization of “responder” in patients with treatment-resistant schizophrenia (TRS) treated with a new antipsychotic added to their current antipsychotic monotherapy. Presented at: European Congress of Psychiatry; March 25-28, 2023; Paris.
• Newron presents 6-month interim data from the first 100 patients randomized in study 014/015 at the 31st European Congress of Psychiatry. https://www.newron.com/sites/newron-pharma-corp/files/news-and-media/regulatory-news/2023/March%2028/Newron%20press%20release%20Results%20presented%20at%20EPA%20March%2028%202023%20EN.pdf. Published March 28, 2023. Accessed April 3, 2023.