Newron’s evenamide brings good news for patients with CNS diseases

The company, which focuses on the development of therapies for patients with diseases of the central nervous system (CNS) said the ‘never reported before’ results from its open-label study evaluating evenamide.

The company reports the data demonstrated that treatment with evenamide was associated with sustained clinically significant benefits that increased throughout the one-year course of treatment.

The results at one year show the addition of evenamide to antipsychotics was well-tolerated.

A treatment-emergent adverse event (TEAE) is an adverse event that occurs only once treatment has started, and this study had few dropouts in relation and no pattern of motor or CNS symptoms, weight gain, sexual dysfunction, or laboratory/electrocardiogram (ECG) abnormalities.  

With 161 TS patients randomized in the study, 75% completed a year of treatment. Causes for attrition, the loss of study units from a sample, 14.3% withdrawal of consent, 5.6% not rolling over into the extension study, 3.1% lost to follow-up and adverse dropouts, 1.9%.

Gradual and sustained improvement

Efficacy results based on change from baseline in the Positive and Negative Syndrome Scale (PANSS), the Clinical Global Impression of Severity (CGI-S), and the Strauss Carpenter Level of Functioning (LOF) showed a statistically significant improvement at one year. All efficacy scales showed gradual and sustained improvement.

In contrast to common clinical experience, no patient ‘relapsed’ during the one-year treatment period. More than 70% of the patients experienced a clinically important reduction in disease severity.

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