Newron Pharmaceuticals S.p.A. announces new results from the first 100 randomized patients who have completed one year (52 weeks) of treatment in its international, randomized, open label, rater-blinded study of evenamide (study 014/015) 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. Results from these same 100 patients at six weeks and six months in study 014/015 have been reported previously. Results in patients completing one year of treatment with evenamide provide further striking new evidence of the sustained efficacy of evenamide as an add-on to antipsychotics (excluding clozapine) in TRS patients, by demonstrating substantially greater benefit at one year than noted at the six-week and six-month datapoints.

The efficacy results, based on changes over baseline at one year in the Positive and Negative Syndrome Scale (PANSS), showed more than a 50% increase over the statistically significant benefit noted at the six-week datapoint (p--value < 0.001: paired t-test). Furthermore, the proportion of patients experiencing a clinically meaningful PANSS improvement (" responders") at one year was almost three times higher than the proportion responding at week six (16%). 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 one year compared to baseline.

The proportion of patients who experienced highly meaningful (at least two categories) improvement in the severity of disease as assessed by the CGI-S more than doubled compared to the proportion of patients improving at week six (10%). The proportion of patients experiencing clinically meaningful improvement (i.e., patients rated at least "much improved") on the Clinical Global Impression of Change (CGI-C) increased by an additional 10% at one year from the proportion at week six (27%). The interim results are based on the first 100 patients randomized to receive evenamide (7.5, 15 or 30 mg bid) in study 014.

Ninety of these entered the long-term treatment period (study 015) and 77 of these reached the 52-week endpoint. Most of the first 100 patients were randomized to receive either the 7.5 or 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 initiation of the randomization to the 30 mg bid dose. The addition of evenamide to the current antipsychotic medication continued to be well tolerated, only two patients discontinued for adverse events (flu-like symptoms and headache) after one year of treatment.