Milan-based Newron Pharmaceuticals has reported “exceptional” one-year results from study 014/15 into evenamide as an add-on to antipsychotics for the management of treatment-resistant schizophrenia (TRS).
The data demonstrated that treatment with evenamide was associated with sustained clinically significant benefit that increased throughout the one-year course of treatment.
In addition, the addition of evenamide to antipsychotics was well tolerated, with a low incidence of treatment-emergent adverse dropouts, and without any pattern of motor or CNS symptoms, weight gain, sexual dysfunction or laboratory/electrocardiogram (EKG) abnormalities.
More than 70% of the patients experienced clinically important reduction in disease severity. A review of the efficacy data indicated that treatment with evenamide resulted in approximately 50% of patients at one-year no longer meeting any of the protocol severity criteria used to diagnose treatment resistance.
In an unexpected result, 25% of all patients achieved ‘remission’, never described before in TRS patients.
The findings support the initiation of a Phase III study of two doses of evenamide (15mg and 30mg bid) as an add-on treatment in patients with TRS.
Commenting on these results, Professor John Kane, Professor of Psychiatry and Molecular Medicine, The Donald and Barbara Zucker School of Medicine, Hempstead New York, stated: “Despite the fact that these results come from an open-label study performed largely in India, the continued improvement on all efficacy measures in TRS patients for one-year, together with the finding that approximately 50% of these patients improved to an extent that they no longer met criteria for TRS is highly encouraging.
“Furthermore, the finding that 25% of TRS patients achieved remission is very unexpected. These results should lead to expediting the conduct of a placebo-controlled international trial to replicate these results.”