Minerva Neurosciences Inc reports results of a clinical trial (ISM2005) of seltorexant (MIN-202) in patients with insomnia disorder that demonstrated highly statistically significant (p ?0.001) and clinically meaningful improvement on latency to persistent sleep at night 1, the primary endpoint of the study. The mean decrease from baseline at night 1 in latency to persistent sleep was 15 minutes for placebo, 30 minutes for seltorexant 5 mg, 50 minutes for seltorexant 10 mg, and 48 minutes for seltorexant 20 mg.
For the key secondary endpoint, wake after sleep onset over first 6 hours at night 1, the mean improvement from baseline at night 1 was 15 minutes for placebo, 23 minutes for seltorexant 5 mg, 43 minutes for 10 mg, and 45 minutes for 20 mg of seltorexant. Furthermore, multiple secondary endpoints were also improved versus placebo and standard of care zolpidem, which is available under the brand name Ambien.
“The findings from this study demonstrate that seltorexant significantly improves sleep induction and prolongs sleep duration,” says Thomas Roth, PhD, director of the Sleep Disorders and Research Center at Henry Ford Hospital, in a release. “The results also demonstrate that seltorexant showed a significantly greater improvement in these sleep parameters compared to zolpidem.
“In addition, the beneficial effects on [latency to persistent sleep] and wake after sleep onset of seltorexant on elderly patients in the study, in conjunction with a favorable tolerability profile, suggest its potential benefit in the large and growing population of elderly patients whose prevalence of insomnia is higher than in younger patients, thus representing an important therapeutic option.”
David Kupfer, MD, distinguished professor emeritus of psychiatry at the University of Pittsburgh School of Medicine and board member of Minerva, says, “Based on these results and those from the recent MDD2001 study, observations of seltorexant include a clinically meaningful improvement in symptoms of depression in patients not responding adequately to firstline therapies (SSRIs and SNRIs) and a clinically meaningful effect on insomnia in a wide age range of patients.
“The demonstration of a significant benefit across a broad spectrum of patients who suffer with depression and/or insomnia and who have not responded adequately to existing therapies points to a differentiated clinical profile and a new way to address an underserved patient population.”
“Seltorexant is a specific orexin-2 antagonist (SORA) rather than a dual orexin receptor antagonist (DORA) and consequently has a differentiated mechanism of action that may help address numerous psychiatric disorders,” says Remy Luthringer, PhD, executive chairman and CEO of Minerva. “Unlike existing therapies, seltorexant is designed to mimic the natural sleep process by inhibiting the brain mechanisms that promote excessive wakefulness rather than by sedating patients through the activation of the neurotransmitters that promote sleep.”