Newron Reports Compelling Additional Data Documenting the Efficacy of Evenamide in Pivotal Study 008A in Poorly Responding Schizophrenia Patients
Ad hoc announcement pursuant to Art. 53 LR
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
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:
- 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.
About evenamide
Evenamide, an orally available new chemical entity, specifically blocks voltage-gated sodium channels (VGSCs) and is devoid of biological activity at >130 other CNS targets. It normalizes glutamate release induced by aberrant sodium channel activity (veratridine-stimulated), without affecting basal glutamate levels, due to inhibition of VGSCs. Combinations of ineffective doses of evenamide and other APs, including clozapine, were associated with benefit in animal models of psychosis, suggesting synergies in mechanisms that may provide benefit in patients who are poor responders to current APs, including clozapine.
About
Newron (SIX: NWRN, XETRA: NP5) is a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system. The Company is headquartered in Bresso near
Supernus Pharmaceuticals holds the commercialization rights in the
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