Newron has reported the interim results from its exploratory clinical trial (study 014/015) of evenamide as an add-on therapy to an antipsychotic (excluding clozapine) in treatment-resistant schizophrenia (TRS) patients.
The randomised, six-week, open label, rater-blinded, global trial is being conducted at several sites in India, Italy, and Sri Lanka.
A total of 161 TRS patients who are receiving a stable, therapeutic dose of a single antipsychotic other than clozapine have been enrolled in the trial.
The study’s primary objective is to assess the tolerability and safety of evenamide, which was orally administered at 7.5mg, 15mg, and 30mg bid fixed doses.
The new findings from the first 100 enrolled participants showed continued improvement in TRS symptoms after receiving treatment with evenamide for six months.
Most of the participants experienced significant improvement when compared with results after six weeks of treatment.
Newron chief medical officer Ravi Anand said: “New therapeutic options are desperately needed for treatment-resistant schizophrenia that occurs in approximately one third of patients.
“These results from studies 014/015 make us excited about the clinical potential of evenamide.
“The data comparing the impact of evenamide at six weeks versus six months, reported today, suggest that not only was there sustained improvement in the key measures, but the proportion of patients achieving clinically meaningful improvement increased over time.
“Confirmation in a controlled trial would support the hypothesis that evenamide treatment is associated with an attenuation of abnormal glutamate activity noted in patients with TRS.”
The complete results from the study are expected in March this year.
The study 015, which is the extension arm, is still ongoing and the results of evenamide treatment for up to one year from the first 100 patients is expected by the second quarter of the year.
As part of the ongoing Phase II/III development plan for evenamide, Newron intends to commence a randomised, placebo-controlled, potentially pivotal, ten-week, multinational study (003) in TRS patients this year.