The biopharmaceutical company is focused on the development of new therapies for patients with diseases of the central and peripheral nervous system (CNS), presented new data yesterday (Monday October, 10) from its study evaluating 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 36th European Clinical Neuropsychopharmacology Congress (ECNP) in Barcelona, Spain.
Ravi Anand, Newron’s chief medical officer, said: “These highly encouraging results from study the study presented yesterday demonstrate the potential benefits of evenamide and its unique glutamatergic mechanism of action. The findings show that the addition of this glutamate modulation to first- and second-generation antipsychotics in patients with TRS potentiates their effects on dopamine dysfunction and can potentially produce a beneficial antipsychotic response.
“What is remarkable about the effect of evenamide in this study is that treatment benefits continue to accrue overtime, and many patients who do not respond early achieve clinically important benefits later. Importantly, over the course of the study period, we found that no patients relapsed or experienced worsened psychosis, and a significant portion of patients improved to the point that they no longer met the criteria to enrol in the study to begin with.”
Results to date show that adding 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. In all 95% of patients completed six weeks of treatment, 94% of the completers chose to continue with evenamide treatment into the planned long-term extension study and 92% of them reached six months of treatment.
Phase 3 trial following encouraging results
Gradual and sustained improvement was evident throughout the trial and in contrast to common clinical experiences Newron said no patients experienced worsening of their psychoses and as a result, nobody relapsed.
The company said that a large number of responders at week six maintained their response at six months. In the review of the efficacy data, Newron said it found the treatment with evenamide resulted in approximately 40% o patients at six months were no longer meeting the protocol severity criteria used to diagnose treatment resistance.
These results have potentially expedited the design of a further study of two doses of evenamide - 15 and 30 mg bid - as an add-on treatment in patients with TRS.
Anand continued: “Following these encouraging results, which have been assessed by our international advisory committee, we are preparing to initiate a potentially pivotal, phase 3, multinational, randomized, double-blind, placebo-controlled trial in patients with TRS and are confident that the results from that study will endorse the use of evenamide as an adjunct treatment to any other antipsychotic as a new therapeutic strategy for TRS.”
A significant proportion of patients with schizophrenia show virtually no beneficial response to antipsychotics despite adequate treatment, leading to a diagnosis of treatment-resistant schizophrenia.
TRS is defined as ‘no, or inadequate, symptomatic relief despite treatment with therapeutic doses of two APs from two different chemical classes for an adequate period’. About 15% of patients develop TRS from illness onset, and about one-third of patients overall. Increasing evidence supports abnormalities in glutamate neurotransmission in TRS, not targeted by current antipsychotics, along with normal dopaminergic synthesis, to explain the lack of benefit of most typical and atypical antipsychotics.