Newron Pharmaceuticals S.p.A. at 12:35 pm CEST presented new data from study 014/015 evaluating its investigational drug evenamide for the management of treatment resistant schizophrenia (TRS). The data, which demonstrated that evenamide treatment was associated with an increasing, sustained, and clinically significant improvement of symptoms were presented at the 36thEuropean Clinical Neuropsychopharmacology Congress (ECNP) in Barcelona, Spain. Results to date show that the addition of evenamide to antipsychotics was well tolerated, with low incidence of treatment-emergent adverse events, or drop out due to intolerance, and no pattern of central nervous system abnormalities.

95% of patients completed six weeks of treatment, 94% of the completers chose to continue with evenamide treatment into the long-term extension study (Study 015) and 92% of them reached six months of treatment. Key findings and conclusions at six months (full study population): Efficacy results based on change from baseline in the Positive and Negative Syndrome Scale (PANSS), the Clinical Global Impression of Severity (CGI-S) as well as the Strauss Carpenter Levels of Functioning (LOF) showed a statistically significant improvement at 6 months (p-value < 0.001: paired t-test, LOCF). All efficacy scales showed gradual and sustained improvement.

In contrast to common clinical experience, no patients experienced worsening of their psychoses; consequently, no patients relapsed. A large proportion of the responders (= 20 % reduction compared to baseline on PANSS total score) at week 6 maintained their response at 6 months. Review of the efficacy data indicated that treatment with evenamide resulted in approximately 40% of patients, at six months, no longer meeting the protocol severity criteria used to diagnose treatment resistance.

These results have expedited the design of a potentially pivotal, Phase III randomized, double-blind, placebo-controlled study of two doses of evenamide (15 and 30 mg bid) as an add-on treatment in patients with TRS.