Minerva Neurosciences has begun patient enrolment in a Phase llb clinical trial of seltorexant (MIN-202) for the treatment of insomnia disorder.
The trial is a multicenter, double-blind, randomised, parallel-group, active- and placebo-controlled dose finding study.
It aims to evaluate the efficacy and safety of seltorexant in both adult and elderly subjects with insomnia disorder.
Minerva Neurosciences president and CEO Dr Remy Luthringer said: “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.
“Patients treated with seltorexant in the Phase 2ll trial were observed to have statistically significant improvements in key sleep parameters, compared to patients who received placebo.
“Data from the Phase lla trial indicate that seltorexant may accelerate sleep induction, restore sleep duration and preserve key phases of sleep, thus enabling restorative sleep.”
Phase llb trial's primary endpoint is to assess the dose-response of three doses of seltorexant including 5mg, 10mg and 20mg daily compared to placebo on sleep onset as measured by the latency to persistent sleep (LPS) using polysomnography (PSG).
The major secondary objective is to examine the dose-response of the three daily doses (5mg, 10mg and 20mg) compared with placebo on wake after sleep onset (WASO) over the first six hours using PSG.
The effects of seltorexant on sleep and cognition will also be compared to those effects of zolpidem to find potential differences between the compounds.
Around 360 patients ranging the age group of 18 to 85 years will be randomised in the study that will be conducted at clinical various sites in the US, EU, and Japan.
During the study, a patient will be screened and followed up for 61 days.