The topline results from an exploratory study, which were released by the developer Newron Pharmaceuticals, are “very encouraging,” Stephen R. Marder, MD, professor of psychiatry and biobehavioral sciences at the University of California, Los Angeles, said in a company news release.
“The magnitude of the improvements experienced by these TRS patients, not responding to their current antipsychotic, on evenamide was substantial, improved over time, and was likely to be clinically meaningful,” Dr. Marder said.
First 100 patients
The topline results are based on the first 100 patients enrolled in study 014 and randomly assigned to receive evenamide at 7.5 mg, 15 mg, or 30 mg twice daily, as well as patients in the extension arm (study 015) that have completed 30 weeks.
Key findings released by the company included statistically significant improvement over baseline at 30 weeks (P < .001) in Positive and Negative Syndrome Scale (PANSS) scores, with continued improvement over that seen at 6 weeks.
The proportion of patients with clinically meaningful PANSS improvement at 30 weeks more than doubled from 16.5% at 6 weeks.
In addition, results showed statistically significant improvement (P < .001) at week 30 compared with baseline in illness severity as measured by the Clinical Global Impression of Severity (CGI-S), with continued improvement over that seen at 6 weeks.
The proportion of patients whose illness improved by at least one level of severity was 60% at week 6 and increased approximately by an additional 20% at week 30.
The proportion of patients judged to have clinically meaningful improvement, defined as at least “much improved,” on the Clinical Global Impression of Change (CGI-C) was 27% at week 6 – and increased a further 10% at week 30.
Evenamide was also well tolerated, with few adverse effects reported, and 85 of 100 patients remained on treatment at 30 weeks.
New options ‘desperately needed’
Newron plans to present the full results from study 014 at the European Congress of Psychiatry, scheduled for March 25-28 in Paris.
The extension study 015 is ongoing and will provide results on evenamide treatment for up to 1 year by the second quarter of 2023.
The company reported it expects to launch a randomized, placebo-controlled study (study 003) of the drug in TRS this year.
If the current results are confirmed in the randomized controlled trial, “evenamide would be the first medication that could be added to an antipsychotic to improve symptoms in treatment-refractory schizophrenia,” Dr. Marder said.
New therapeutic options for TRS, which occurs in about one-third of patients, are “desperately needed,” Ravi Anand, MD, chief medical officer at Newron, said in the release.
The reported data, comparing the effect of evenamide at 6 weeks vs. 6 months, “suggest that not only was there sustained improvement in the key measures, but the proportion of patients achieving clinically meaningful improvement increased over time,” Dr. Anand added.
A version of this article first appeared on.