Seltorexant (MIN-202) Achieves Primary and Key Secondary Endpoints in Phase 2b Clinical Trial for Insomnia, Demonstrating Superior Efficacy Over Zolpidem

Minerva Neurosciences Announces That Seltorexant (MIN-202), Co-Developed with Janssen, Met Primary and Key Secondary Endpoints in Phase 2b Clinical Trial for Insomnia, Significantly Reducing Sleep Onset Latency and Wake After Sleep Onset

According to estimates from the American Academy of Sleep Medicine, 30–35% of adults experience transient insomnia symptoms, while 10% suffer from chronic insomnia (defined as experiencing insomnia symptoms at least three times per week for a duration of at least three months). Chronic insomnia has adverse effects on health, and patients with insomnia often present with comorbid psychiatric disorders, such as depression and anxiety.

Insomnia has a higher prevalence in women and the elderly, and its health impact is particularly severe in individuals aged over 65 years, showing significant correlation with morbidity and mortality in this population.

Seltorexant is a potential “first-in-class” orexin-2 receptor–selective antagonist for the treatment of insomnia. The brain’s orexin system is involved in various physiological functions, including metabolism, stress response, and wakefulness. In patients with insomnia and some individuals with mood disorders, this system may contribute to hyperarousal. By inhibiting this system, seltorexant may alleviate patient symptoms.

▲ Molecular structure of seltorexant (Image source: Vaccinationist [Public domain])

In a randomized, double-blind, multicenter Phase 2b clinical trial with both placebo and active controls, 365 patients received treatment with varying doses of seltorexant, varying doses of zolpidem, or placebo. The primary efficacy endpoint was the latency to persistent sleep (LPS) on the first night of treatment. Key secondary endpoints included wake after sleep onset over the first 6 hours (WASO-6), as well as safety and tolerability measures.

Trial results demonstrated that, compared with placebo, seltorexant provided statistically significant (p<0.001) and clinically meaningful improvements in Latency to Persistent Sleep (LPS). On the first night of treatment, seltorexant reduced mean LPS by 50 minutes (10 mg dose) or 48 minutes (20 mg dose), whereas the reduction in the placebo group was 15 minutes.

Meanwhile, seltorexant reduced WASO-6 by 43 minutes (10 mg dose) or 45 minutes (20 mg dose), compared with 15 minutes in the placebo group.

Seltorexant (20 mg dose) also demonstrated superior improvement in LPS on the first night compared to the active control group (p<0.010).

“The findings of this study indicate that seltorexant can significantly improve the process of falling asleep and extend sleep duration,” said Professor Thomas Roth, Director of the Sleep Disorders and Research Center at Henry Ford Hospital. “The trial results also demonstrated that it outperforms zolpidem in improving sleep metrics.”

“Moreover, the improvement in LPS and WASO observed with seltorexant in elderly patients in this study suggests that it may provide an important treatment option for this population, which has a higher prevalence of insomnia than younger patients,” added Professor Roth.

References:

[1] Minerva Neurosciences Announces Achievement of Primary and Key Secondary Objectives in Phase 2b Clinical Trial of Seltorexant (MIN-202) in Insomnia. Retrieved June 24, 2019, from http://ir.minervaneurosciences.com/news-releases/news-release-details/minerva-neurosciences-announces-achievement-primary-and-key

Flash | Innovative Insomnia Drug Meets Phase 2b Clinical Endpoints, Outperforming Common Therapies

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