Newron Pharmaceuticals S.p.A. announced very compelling new results from the first 100 enrolled patients to have reached the six-month (30 weeks) timepoint in its 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), who were not responding to their current antipsychotic medication (study 014/015). 85 of the 100 patients completed the 30-week treatment period with evenamide. The results follow on from the company's announcement on June 7, 2022, summarizing the data from an interim analysis of the first 100 patients to have finished six weeks of treatment in this study.

These new results demonstrated a continued improvement in TRS symptoms after six months of treatment with evenamide, as well as a substantially greater proportion of patients experiencing a meaningful improvement when compared to six weeks of treatment. The efficacy results based on changes over baseline in the Positive and Negative Syndrome Scale (PANSS) showed a statistically significant improvement at week 30 (p-value < 0.001: paired t-test); continued improvement was seen when compared to the improvement seen at week six. The proportion of patients demonstrating a clinically meaningful PANSS improvement ("responders") at week 30 more than doubled from 16.5% at week six.

In addition, the mean change for the severity of illness (as measured by Clinical Global Impression of Severity (CGI-S)) showed a statistically significant improvement at week 30 compared to baseline (statistically significant, p-value < 0.001: paired t-test), as well as continued improvement when compared to week six, and the proportion of patients whose illness improved by at least one level of severity increased from 60% at week six by an additional approximately 20% at week 30. Furthermore, the proportion of patients judged to have clinically meaningfully improved (i.e. patients rated at least "much improved") on the Clinical Global Impression of Change (CGI-C) increased by another 10% from the proportion at week six (27%). The addition of evenamide to the current antipsychotic medication of the patients continued to be well tolerated after six months of treatment.

The top-line results are based on the first 100 enrolled patients, randomized to receive evenamide (7.5 15 and 30 mg bid) in study 014 and the extension arm of the study, 015, to have reached the six-month timepoint. The majority of the first 100 patients were randomized to receive either the 7.5 and 15 mg bid doses, as patients were initially randomized to treatment with these doses before an Independent Safety Monitoring Board reviewed the safety data from the first 50 patients completing the trial and agreed with the randomization to the 30 mg bid dose.