Evenamide: New Results Show 70% of Patients Saw Reduction in Treatment-Resistant Schizophrenia Severity

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A 1-year open label study evaluating evenamide as an add-on to antipsychotics for the management of treatment-resistant schizophrenia (TRS) demonstrated positive results, with evenamide showing sustained benefit that increased throughout the 1-year course of treatment. More than 70% of the patients experienced clinically significant reduction in disease severity.¹

“Treatment with evenamide as an add-on to antipsychotics in TRS patients has produced benefits that have never been reported before. Despite these patients being on therapeutic doses of antipsychotics, evenamide treatment was associated with clinically important improvement (≥20%) on PANSS in approximately 40% of patients, functioning (LOF) in over 60% of patients, and reduction in the severity of disease (CGI-S) in over 70% of patients,” said Ravi Anand, Newron’s Chief Medical Officer.

Evenamide as an add-on 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.

In the study, 161 participants with TRS were randomized and 75% completed treatment. Approximately 90% of participants who saw a clinically important reduction (≥ 20% from baseline) on PANSS total score at 6 months (approximately 45%) maintained their response at 1-year. Approximately 50% of participants no longer met any protocol severity criteria for TRS after the year of treatment and 25% of all patients achieved remission, according to the efficacy data. Additionally, no participant relapsed during the treatment period.

“Despite the fact that these results come from an open-label study performedlargely in India, thecontinued improvement on all efficacy measures in TRS patients for 1-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,” said John Kane, professor of psychiatry and molecular medicine at the Donald and Barbara Zucker School of Medicine.

These findings support the initiation of a phase III, randomized, double-blind, placebo-controlled study of 2 doses of evenamide (15 and 30 mg twice daily) as an add-on treatment in patients with TRS.

Reference

1. Newron reports exceptional one-year results of study 014/15 with evenamide in treatment-resistant schizophrenia (TRS). Newron. News release. January 4, 2024. https://www.newron.com/news-and-media/regulatory-news/newron-reports-exceptional-one-year-results-study-01415-evenamide