Minerva Neurosciences, Inc, a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, has enrolled its first patient in a Phase 2b clinical trial of seltorexant (MIN-202) in patients with insomnia disorder.
This multicenter, double-blind, randomized, parallel-group, active- and placebo-controlled dose finding study is designed to assess the efficacy and safety of seltorexant in both adult and elderly subjects with insomnia disorder. The primary objective of this trial is to assess the dose-response of three doses of seltorexant (5, 10, and 20 mg daily) compared to placebo on sleep onset as measured by the latency to persistent sleep using polysomnography (PSG). The key secondary objective is to assess the dose-response of these 3 doses compared to placebo on wake after sleep onset over the first 6 hours using PSG. In addition, the effects of seltorexant on sleep and cognition will be compared to those effects of zolpidem to determine potential differences between the compounds.
“Activation of the orexin-2 receptor pathway is believed to contribute to the maintenance of wakefulness, and the blockade of this pathway represents a novel pharmacologic approach for the treatment of insomnia,” says Remy Luthringer, PhD, president and CEO of Minerva, in a release. “Patients treated with seltorexant in the Phase 2a trial were observed to have statistically significant improvements in key sleep parameters, compared to patients who received placebo. Data from the Phase 2a trial indicate that seltorexant may accelerate sleep induction, restore sleep duration and preserve key phases of sleep, thus enabling restorative sleep.”
A total of approximately 360 patients 18 to 85 years of age will be randomized in this study at clinical sites in the United States, European Union, and Japan. The duration of participation in this study for an individual subject will be up to 61 days, including screening and follow-up.
Seltorexant is a selective orexin 2 receptor antagonist under co-development by Janssen Pharmaceutica NV and Minerva for the treatment of insomnia disorder and as adjunctive therapy for major depressive disorder.