Positive results in phase 2 trial of add-on drug for treatment-resistant schizophrenia

Key Takeaways:

• Phase 2 study of drug met efficacy endpoints across several behavioral metrics
• 144 participants entered extension study

A biopharmaceutical company has announced positive topline results from its phase 2, randomized, open-label trial of evenamide as an add-on to antipsychotic medication in those with moderate to severe treatment-resistant schizophrenia.

According to a release from Newron Pharmaceuticals, evenamide is an orally available novel chemical that specifically blocks voltage-gated sodium channels and normalizes glutamate release induced by aberrant sodium channel activity without affecting basal glutamate levels, due to inhibition of VGSCs.

The study, a 6-week rater-blinded trial conducted at multiple sites in India, Sri Lanka and Italy, enrolled 161 individuals given evenamide at three separate doses (7.5 mg, 15 mg or 30 mg).

Ultimately, 153 participants completed the treatment period and 144 entered an extension study that aims to determine long-term benefits of glutamate release inhibition, the release said.

Overall, per the release, results from the complete study population are fully consistent with the findings from the first 100 patients, showing significant improvements in mean Positive and Negative Syndrome Scale (PANSS) total score, Clinical Global Impression of Severity (CGI-S) rating and Strauss-Carpenter Level of Functioning (LOF) compared to baseline.

Among the first 100 patients in the trial, 77 completed 1 year of treatment with evenamide, 16 discontinued the study early, with two doing so due to adverse events and the remaining 14 due to withdrawal of consent or lost to follow up, according to the company.

Adverse events during the study were recorded in 26% of participants with no severe events logged. The most common reported events were dizziness, pyrexia, and CPK increase.

“The final results ... are exciting,” Ravi Anand, MD, Newron’s chief medical officer, said in the release. “Treatment with evenamide at all doses (7.5 mg, 15 mg or 30 mg bid) was also as well tolerated in the final 61 patients as was shown in the initial cohort of 100 patients, thus confirming the reliability of the data collected in this study.”

Detailed results from the study are expected to be presented at the 36th European College of Neuropsychopharmacology Congress, taking place Oct. 7 to Oct. 10 in Barcelona, Spain.