EQS-News

Data from Newron’s study 014/015 and an evenamide clinical development outlook presented at the 2024 Annual Congress of the Schizophrenia International Research Society (SIRS) - Seite 3

• Glutamate modulation by evenamide as an add-on to TRS patients not responding to current antipsychotics is associated with clinically important improvement across outcome measures; results from a pilot, 1-year, open-label trial in treatment resistant schizophrenia (TRS)
• Study 008A: Add-on treatment with evenamide in patients with chronic schizophrenia not responding adequately to their current antipsychotic – Patient disposition and characteristics, challenges/issues in enrolling patients and study conduct

All posters and presentations presented are available at Newron’s website.

 

About treatment-resistant schizophrenia (TRS)
A significant proportion of patients with schizophrenia show virtually no beneficial response to antipsychotics (APs) despite adequate treatment, leading to a diagnosis of treatment-resistant schizophrenia (TRS). TRS is defined as no, or inadequate, symptomatic relief despite treatment with therapeutic doses of two APs from two different chemical classes for an adequate period. About 15% of patients develop TRS from illness onset, and about one-third of patients overall. Increasing evidence supports abnormalities in glutamate neurotransmission in TRS, not targeted by current APs, along with normal dopaminergic synthesis, to explain the lack of benefit of most typical and atypical antipsychotics.

About Study 014/015
Study 014 was a six-week, randomized, rater-blinded study being conducted at multiple sites in three countries (India, Italy and Sri Lanka). Study 014 enrolled 161 patients with TRS on a stable, therapeutic dose of a single antipsychotic other than clozapine. The primary objective of the study was to evaluate the safety and tolerability of evenamide given orally at three fixed doses (7.5, 15 and 30 mg bid). The assessment of preliminary efficacy was based on changes from baseline in the Positive and Negative Syndrome Scale (PANSS). Changes from baseline in Clinical Global Impression of Change (CGI-C), Severity of Illness (CGI-S), and Strauss-Carpenter Level of Functioning (LOF) scale, were secondary objectives. Study 015 was the extension study to determine the long-term benefits of glutamate release inhibition, up to 1 year of treatment with evenamide.