Seltorexant showed a quantitative advantage in the number of discontinuations due to all causes, with 41% discontinuation in the seltorexant arm versus 47% in the quetiapine XR arm. As expected, there was not a statistical separation between the two treatment arms.
Mood improvement as measured by MADRS total score showed patients treated with seltorexant 20 mg dose experienced a greater improvement at week 24(-22.7 points), compared to those treated with seltorexant 40 mg dose(-7.9 points), quetiapine 150 mg dose(-17.0 points) and quetiapine 300 mg dose(-14.8 points). As was shown in previous trials of seltorexant in MDD, a greater improvement in MADRS total score was observed in patients with sleep disturbance (Insomnia Severity Index³15) who received the 20 mg seltorexant dose. In these patients with insomnia, the improvements observed were-26.5 for the 20 mg seltorexant dose,-7.0 for the 40 mg seltorexant dose,-18.2 for the 150 mg quetiapine dose and-13.8 for the 300 mg quetiapine dose.
The overall safety profile of the seltorexant groups was favorable compared to quetiapine, consistent with prior seltorexant studies, and extended to longer-term exposure over 6 months. Patients receiving seltorexant also experienced fewer potentially treatment-related discontinuations than did patients receiving quetiapine (29.4% vs 47.1%).
The results of this study, taken with the results of the two previous studies (MDD2001 in MDD patients and ISM2005 in patients with insomnia), will help to define a Phase 3 clinical development program for seltorexant that potentially will encompass both MDD and insomnia.
Conference Call Information:
Minerva Neurosciences will hold a conference call and live audio webcast on October 1, 2019 at 8:30 a.m. Eastern Time to discuss the results of this trial. To participate, please dial (877)312-5845 (domestic) or (765)507-2618 (international) and refer to conference ID 7235727 To access the webcast, please go tohttps://edge.media-server.com/mmc/p/xazdqtav..
The live webcast can also be accessed under “Events and Presentations” in the Investors and Media section of Minerva’s website at ir.minervaneurosciences.com. The archived webcast will be available on the website beginning approximately two hours after the event for 90 days.
About Minerva Neurosciences
Minerva Neurosciences, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of a portfolio of product candidates to treat CNS diseases. Minerva’s proprietary compounds include: roluperidone(MIN-101), in clinical development for schizophrenia; seltorexant(MIN-202 orJNJ-42847922), in clinical development for insomnia and Major Depressive Disorder (MDD);MIN-117, in clinical development for MDD; andMIN-301, inpre-clinical development for Parkinson’s disease. Minerva’s common stock is listed on the NASDAQ Global Market under the symbol “NERV.” For more information, please visit http://www.minervaneurosciences.com.
Forward-Looking Safe Harbor Statement
This press release contains forward-looking statements which are subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts, reflect management’s expectations as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include statements herein with respect to the timing and scope of future clinical trials and results of clinical trials with