EQS-News

Newron reports compelling additional data documenting the efficacy of evenamide in pivotal study 008A in poorly responding schizophrenia patients - Seite 2

• PANSS total worst observation carried forward (WOCF) ANCOVA p-value = 0.008;
• PANSS total Multiple Imputation (MI) ANCOVA: p-value = 0.006;
• CGI-S Multiple Imputation (MI) ANCOVA: p-value = 0.014.

In the study, the addition of 30 mg (bid) of evenamide to the patients’ current antipsychotic medication was very well tolerated, with a similar profile to placebo with no increases in EPS, weight gain, blood glucose, metabolic syndrome, sexual dysfunction, CNS or cardiac effects, or laboratory abnormalities.

Study 008A is the first well-designed study demonstrating efficacy of an adjunctive treatment in benefiting patients who do not respond to their current antipsychotic. Evenamide also is the first glutamate modulator to demonstrate efficacy in inadequately responding patients with schizophrenia in a placebo-controlled study.

Ravi Anand, MD, Chief Medical Officer of Newron, stated: “These new efficacy results from study 008A attest to the clinical relevance of the benefits for patients, based on the primary and key secondary endpoints. The results for the CGI-C rated by an experienced psychiatrist who assesses not only the symptoms of psychosis, but also the impact of treatment on social interactions, insight, and functioning, indicated a significant proportion of evenamide patients were considered as at least ‘much improved’. Significant improvement was also noted on both positive and negative symptoms of schizophrenia. Most importantly, the benefits noted on the efficacy measures increased up to Day 29, thus suggesting larger and enduring effects during longer term treatment. These findings, along with those noted in study 014/015, where patients with treatment resistant schizophrenia treated with evenamide for 1-year experienced progressive, sustained and long-lasting clinically significant important benefits, further highlight the growing importance of glutamate modulation for the development of novel treatments for patients with schizophrenia.”