Biopharmaceutical company Minerva Neurosciences has reported positive data from the Phase IIb clinical trial of seltorexant (MIN-202) as an adjunct to antidepressants in adults suffering from major depressive disorder (MDD).
The trial enrolled patients who did not experience adequate response to selective serotonin reuptake inhibitors (SSRIs) and / or serotonin-norepinephrine reuptake inhibitors (SNRIs).
According to the top-line results, 20mg seltorexant led to a statistically significant improvement in the Montgomery-Asberg Depression Rating Scale (MADRS) score when compared to placebo.
The drug also demonstrated a statistically significant improvement after three weeks of therapy.
Furthermore, a key secondary outcome measure involving patient stratification based on baseline insomnia severity index (ISI ) revealed a significant difference between the study drug and placebo in patients with clinically significant insomnia.
A 40mg dose of seltorexant also showed an improvement in the MADRS total score at the end of week six, compared to placebo, but did not achieve statistical significance.
During the study, seltorexant was observed to be well-tolerated and adverse events were consistent with those found in prior studies. The adverse events rate was also similar to or lower than that of the placebo group.
Minerva Neurosciences executive chairman and CEO Dr Remy Luthringer said: “These findings, if confirmed in Phase III studies, point to a completely novel approach, which would give hope to patients and to the professionals who treat them for a potential new treatment for MDD with an improved safety profile compared to existing therapies.
“Around 60%-70% of patients diagnosed and treated with first-line therapies, including SSRIs and / or SNRIs, do not experience adequate treatment response, and seltorexant potentially represents a unique opportunity to improve treatment response rates safely in most of these patients.”
Developed in collaboration with Janssen Pharmaceutica , seltorexant is an orexin receptor 2 (ORX2) antagonistic intended to treat MDD and insomnia without associated psychiatric disorders.
The dose-finding, multi-centre, double-blind, randomised, parallel-group, placebo-controlled Phase IIb trial assessed the drug in 287 patients at 84 sites across the US, Europe, and Japan.