Minerva Neurosciences, Inc. (NASDAQ: NERV) shares jumped on Monday after the company announced positive topline results from its two mid-stage studies in major depressive disorder (MDD) and insomnia. Specifically, these were two Phase 2b studies of seltorexant.
In the MDD study, the primary endpoint analysis showed a significant treatment effect at week 5 for seltorexant versus placebo. The efficacy signal for the 20 mg dose was statistically significant and more pronounced in the MDD population with sleep disorder.
These new findings show that seltorexant administered as monotherapy improves depressive symptoms and that the improvement is more pronounced when patients present with insomnia. Importantly, they also support the relationship between mood disorders, insomnia, hyper-arousal, clinical efficacy and the mechanism of action of seltorexant.
Separately, the firm announced positive top line results from a Phase 2b clinical trial of seltorexant in patients with insomnia disorder that demonstrated highly statistically significant and clinically meaningful improvement in the primary endpoint, Latency to Persistent Sleep (LPS) at Night 1.
In addition to the primary endpoint, multiple secondary endpoints were improved with seltorexant versus placebo and standard of care zolpidem, available under the brand name Ambien. Furthermore, the beneficial effects of seltorexant on elderly patients, in conjunction with a favorable safety profile, suggest its potential benefit in the large and growing population of elderly patients whose prevalence of insomnia is higher than in younger patients.
Dr. Remy Luthringer, Executive Chairman and CEO of Minerva, commented:
In the first half of 2019, we presented positive data from two Phase 2b clinical trials with seltorexant. In addition, in a recent biomarker study with seltorexant, we demonstrated mood improvements in MDD patients when seltorexant was given as monotherapy. Taken together, the data from these studies point to the unique ability of seltorexant to address unmet medical needs in both depression and insomnia as an adjunctive treatment or in monotherapy.
Shares of Minerva were last seen up over 8% at $6.99, with a 52-week range of $4.07 to $12.95. The consensus analyst price target is $19.75.