Newron Pharmaceuticals S.p.A. Presents Six-Month Interim Data from the First 100 Patients Randomized in Study 014/015 At the 31St European Congress of Psychiatry
The first poster presented full results from the cohort of the first 100 patients completing six months/endpoint of treatment with evenamide in study 014/015. Study 014/015 is an international, randomized, open label, rater-blinded study of evenamide as an add-on to an antipsychotic (excluding clozapine) in patients with moderate to severe treatment-resistant schizophrenia (TRS) not responding to their current antipsychotic medication. Top-line six-month results from this cohort of patients were announced in January 2023, and top-line one-year results were announced in February 2023. Efficacy results based on changes from baseline in the Positive and Negative Syndrome Scale (PANSS) as well as CGI-S showed a statistically significant improvement at six months (p-value < 0.001: paired t-test, LOCF). All other efficacy scales showed gradual and sustained improvement during the same period. The PANSS total score improved by approximately 13 points (16%) compared to baseline; the PANSS responder rate was 39%, more than double compared to week six (16%). Ratings of the Clinical Global Impression of Change (CGI-C) indicated that 85% of the patients experienced at least a minimal improvement; 36% of the patients were rated as much or very much improved; this represents an increase of approximately 10% from week 6.
The Clinical Global Impression of Severity (CGI-S) improved (i.e., the disease severity was considered reduced) by 0.9 units from baseline. The addition of evenamide to antipsychotics was well tolerated, with low incidence of treatment-emergent adverse events, the most frequent were pyrexia (3%) and insomnia (3%). 97% of patients completed six weeks of treatment, and more than 90% of the completers chose to continue with evenamide treatment into the long-term extension study. This was the first international trial of an antipsychotic new chemical entity (NCE) as an add-on to a single antipsychotic in patients with TRS who were not responding to their current medication. These results suggest a new strategy for the management of TRS patients in the future.