EQS-News

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

EQS-News: Newron Pharmaceuticals S.p.A. / Key word(s): Study results Newron reports compelling additional data documenting the efficacy of evenamide in pivotal study 008A in poorly responding schizophrenia patients 13.05.2024 / 07:00 CET/CEST The issuer is solely responsible for the content of this announcement. Newron reports compelling additional data documenting the efficacy of evenamide in pivotal study 008A in poorly responding schizophrenia patients

Further study analysis reveals significant multi-domain benefits in PANSS and Clinical Global Impression of Change (CGI-C) ratings 

Benefit on efficacy measures increased over time, suggesting larger and enduring patient effects to be expected during long-term treatment 

Milan, Italy, May 13, 2024, 07:00 am CEST – Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system (CNS), presents additional results from the international, randomized, double-blind, placebo-controlled study 008A that evaluated the efficacy and safety of evenamide (30 mg bid) as add-on treatment in 291 patients not benefitting from their second-generation antipsychotic medication, including clozapine. Initial top line data announced on 30^th April 2024 demonstrated that the study met its primary endpoint, an improvement of the Positive and Negative Syndrome Scale (PANSS) Total Score as well as the key secondary endpoint, an improvement of the Clinical Global Impression of Severity (CGI-S), in the a-priori defined regulatory analysis.

Additional analyses for the secondary endpoints indicate significant effects achieved at the endpoint (Day 29), on all the following measures:

• PANSS total: Proportion of patients with a clinically relevant improvement (more than 20% improvement from baseline); p-value < 0.05;
• Clinical Global Impression of Change (CGI-C): Mean rating at endpoint; evenamide 3.3 versus placebo 3.5; p-value < 0.001;
• Clinical Global Impression of Change (CGI-C): Proportion of patients rated as showing any improvement; p-value < 0.05;
• Clinical Global Impression of Change (CGI-C): Proportion of patients rated as at least “much improved”; evenamide: 31.3% versus placebo: 17.3%; p-value = 0.006;
• PANSS Positive subscale: Mean change from baseline; p-value < 0.05;
• PANSS Negative subscale: Mean change from baseline; p-value < 0.05.

The sensitivity analyses for the PANSS total (primary endpoint) and CGI-S (secondary endpoint) confirmed a statistically significant improvement for evenamide irrespective of the population analyzed and the statistical methods used; some examples are provided below: