Evenamide meets primary endpoint in phase 2/3 study of patients with schizophrenia
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Key takeaways:
- Evenamide met it primary endpoint of improvement on the Positive and Negative Syndrome Scale.
- The addition of evenamide to patients’ current antipsychotic therapy was well-tolerated, with no new safety concerns.
Newron Pharmaceuticals announced positive topline results from its phase 2/3 study of evenamide for patients with chronic schizophrenia who have an inadequate response to current treatment with a second-generation antipsychotic.
According to company press release, the 4-week, randomized, double-blind, placebo-controlled study 008A was conducted at 45 centers in Europe, Asia and Latin America and enrolled 291 patients who received 30 mg evenamide twice a day or placebo, in addition to their current antipsychotic medication. Evenamide, an investigational oral therapy, works by specifically blocking voltage-gated sodium channels and normalizing glutamate release.
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The study met its primary endpoint of improvement on the Positive and Negative Syndrome Scale (PANSS). At day 29, the addition of evenamide to the patients’ current antipsychotic medication was associated with a highly statistically significant PANSS total score reduction of 10.2 points vs. a 7.6-point reduction with placebo, a least squares mean difference of 2.5, the release stated. A key secondary endpoint — improvement in the Clinical Global Impressions scale — also was met.
“The results seen in study 008A with evenamide are groundbreaking and unique from many perspectives,” Ravi Anand, MD, Newron’s chief medical officer, said in the release. “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.”
The release also stated that evenamide was well-tolerated, with no new or specific safety concerns identified. Just 25% of patients experienced at least one adverse effect, and only three participants — two on evenamide and one on placebo who died — discontinued the study due to adverse effects. The most common adverse events associated with evenamide were headache, vomiting and nasopharyngitis.