Newron Pharmaceuticals said that evenamide (30mg bid) has met the primary endpoint and a key secondary endpoint of the Phase 2/3 008A study in patients with chronic schizophrenia.
Evenamide is an orally administered compound that selectively blocks voltage-gated sodium channels (VGSCs). It is said to have no detectable biological effects on over 130 other central nervous system (CNS) targets.
The 008A trial assessed the safety, tolerability, and efficacy of evenamide in schizophrenia patients who are on second-generation antipsychotics including clozapine but showing inadequate response.
The four-week, international, randomised, double-blind, and placebo-controlled add-on study randomised 291 patients to receive either evenamide or placebo as an add-on to their current antipsychotic therapy.
According to Newron Pharmaceuticals, the Phase 2/3 trial achieved its primary endpoint of improvement on the Positive and Negative Syndrome Scale (PANSS) Total Score.
It also met its key secondary endpoint of improvement of the Clinical Global Impression of Severity (CGI-S).
Evenamide demonstrated its favourable safety and tolerability profile, with a high completion rate.
Out of the 291 patients enrolled, 280 completed the study. Only three patients discontinued participation due to adverse events. The 008A study did not raise any new or specific concerns.
Newron Pharmaceuticals chief medical officer Ravi Anand said: “The results seen in study 008A with evenamide are ground-breaking and unique from many perspectives.
“This is the first major international study to demonstrate the significant benefit of adding a new chemical entity (NCE) to poorly responding, compliant schizophrenia patients being treated with a second-generation antipsychotic.
“It is also the first demonstration of efficacy in a placebo-controlled trial of a NCE acting exclusively through glutamatergic inhibition.
“These results, together with the recently reported one-year efficacy results in treatment-resistant patients, substantiate the pivotal role of glutamate in finding new therapeutic options for schizophrenia patients.”
The Italian biopharmaceutical company is now planning to start a Phase 3, one-year, randomised, double-blind, placebo-controlled trial of evenamide in treatment resistant schizophrenia (TRS).
Newron Pharmaceuticals is focused on the development of new therapies for patients with diseases of the central and peripheral nervous system (CNS).
The company’s Xadago/ safinamide has approval to treat Parkinson’s disease in the US, European Union, the UK, and other countries. It is being commercialised by the company’s partner Zambon.
