Minerva Neurosciences Announces Positive Top Line Results in Phase 2b Clinical Trial With Seltorexant (MIN-202) in Treatment of Depressed Patients With an Inadequate Response to SSRIs and SNRIs

  • Potential first-in-class, oral specific orexin-2 inhibitor demonstrates statistically significant improvement in MADRS scores at 6 weeks compared to placebo
  • Well tolerated, with adverse events similar to or lower than the rate observed in the placebo group
  • Improves depressive symptoms and sleep function, thus differentiating seltorexant from current therapies
  • Demonstrates improvement in symptoms of MDD patients not adequately treated by SSRIs and/or SNRIs, a significant unmet need
  • Data support ongoing development of seltorexant in MDD

WALTHAM, Mass., May 13, 2019 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today announced positive results from a Phase 2b clinical trial of seltorexant (MIN-202) as adjunctive therapy to antidepressants in adult patients with major depressive disorder (MDD) who have responded inadequately to selective serotonin reuptake inhibitors (SSRIs) and/or serotonin-norepinephrine reuptake inhibitors (SNRIs).

In this dose finding study, the 20 milligram (mg) dose of seltorexant, under co-development with Janssen Pharmaceutica NV,  showed a statistically significant improvement in the MADRS (Montgomery-Asberg Depression Rating Scale) score compared to placebo. The least squares mean (LS mean) difference from placebo of the change in MADRS total score at the end of week 6 was 3.1 for the 20 mg dose of seltorexant, and the 2-sided p-value was 0.083, which is below the pre-specified 2-sided type I error level of 0.1.

After three weeks of treatment, seltorexant at the 20 mg dose also showed a statistically significant improvement over placebo, highlighting its ability to improve mood symptoms over a short period of time. In addition, a key secondary outcome measure, which was based on patient stratification according to baseline insomnia severity index (ISI), showed an even greater difference from placebo for the seltorexant 20 mg arm in patients with clinically significant insomnia (ISI ≥ 15) with LS mean difference versus placebo of 4.9 on the MADRS total score and a 2-sided p-value of 0.050 compared to the overall patient population in this trial.

The 40 mg dose, to which further enrollment was stopped following the interim analysis, showed an improvement in the MADRS total score versus placebo at the end of week 6 but did not reach statistical significance.  Results for the 10 mg dose were not interpretable due to the small sample size of patients assigned to this dose.

Seltorexant was well tolerated, and adverse events recorded were similar to those observed in previous studies and similar to or lower than the rate observed in the placebo group.

“Results of this study represent the first clinical observation in a large, late-stage study that a selective orexin molecule can achieve a positive effect as an adjunctive treatment in patients with MDD who have an inadequate response to SSRIs and SNRIs,” said Dr. Remy Luthringer, Executive Chairman and Chief Executive Officer of Minerva.  “These findings, if confirmed in Phase 3 studies, point to a completely novel approach which would give hope to patients and to the professionals who treat them for a potential new treatment for MDD with an improved safety profile compared to existing therapies.  Around 60%-70% of patients diagnosed and treated with first-line therapies, including SSRIs and/or SNRIs, do not experience adequate treatment response, and seltorexant potentially represents a unique opportunity to improve treatment response rates safely in most of these patients.”

Dr. Luthringer added, “The top line results from a separate Phase 2b trial of seltorexant in insomnia, now completely enrolled, are expected to be announced later this quarter and will add to the body of clinical data with seltorexant in insomnia and MDD.”

About the Phase 2b study (aMDD2001)

The multicenter, double-blind, randomized, parallel-group, placebo-controlled, 6-week adaptive dose-finding study consisted of three phases: a screening phase lasting up to 4 weeks, a 6-week double-blind treatment phase and a 2-week post-treatment follow-up phase. In total, 287 adult patients were enrolled at 84 clinical sites in the U.S., Europe and Japan. The study was powered for a 2-sided type I error level of 0.100. The objectives of the study were to evaluate which dose(s) of seltorexant shows a statistically significant difference from placebo on mood using the MADRS scale after 6 weeks of treatment, to assess the influence of insomnia on the observed effects on mood, and to further evaluate the overall safety and tolerability of seltorexant.

At commencement of study enrollment, subjects were randomly assigned to receive 1 of 3 treatments in a 2:1:1 ratio of seltorexant to placebo (20 mg, 40 mg).  After a pre-planned interim analysis (IA), subjects were randomly assigned to receive 1 of 3 treatments in a 3:3:1 ratio of seltorexant to placebo (10 mg, 20 mg). The randomization was stratified by region (U.S., Europe, and Japan) and by baseline insomnia status (insomnia severity index, or ISI, score ≥15 versus <15). A mixed model for repeated measures (MMRM) analysis was preplanned (analysis of response by each dose, compared to placebo).

Seltorexant and the Major Depressive Disorder (MDD) landscape

Major Depressive Disorder (MDD) is one of the most commonly encountered mental disorders, with a prevalence rate in the United States of 4.7%. Globally, more than 300 million people of all ages suffer from depression.  Depression is the leading cause of disability worldwide and is a major contributor to the overall global burden of disease.  It is associated with significant comorbid medical conditions that include diabetes, hypertension and cardiovascular disease, and there is an increased risk of early mortality in patients with MDD.

Among those patients suffering from MDD disorders, some do not respond adequately to either SSRIs or SNRIs. Inadequate response to these pharmacological treatments is a major challenge to worldwide public health. Although it is widely considered that current intervention benefits approximately 60% of MDD patients, only about 30% to 40% of patients show full remission of their symptoms as defined by the MacArthur criteria (for example, a 17-item Hamilton Depression Rating Scale (HDRS) score < 8).

To overcome the lack of adequate response, the use of atypical antipsychotics as adjunctive therapy for the management of patients with an inadequate response to standard of care has become one of the most widely used therapeutic strategies. Use of adjunctive atypical antipsychotics for MDD is associated with significant side effects such as weight gain, akathisia, and sedation. Several other approaches have been evaluated but, in most cases, with non-conclusive results.

Innovative approaches are needed to improve current response rates to existing treatments. The orexin system is viewed as a pivotal system in the brain and its effects classically include promotion of feeding, maintaining homeostasis, arousal, modulation of sleep-wake circadian cycles and motivation. These functions are mediated via two orexin receptors, ORX1 and ORX2.

Seltorexant is the most advanced specific ORX2 molecule in clinical development with antagonistic activity when binding to its receptor. Seltorexant is currently being developed in two indications, specifically insomnia without associated psychiatric disorders and MDD in patients who have an inadequate response to SSRIs and SNRIs. Previous clinical trials have indicated that seltorexant might be useful in both indications. 

About Seltorexant (MIN-202)

Seltorexant is a selective orexin-2 receptor antagonist under co-development by Janssen Pharmaceutica NV and Minerva as adjunctive therapy for MDD and for the treatment of insomnia disorder. The orexin system in the brain is involved in the control of several key functions, including metabolism, stress response and wakefulness. This system promotes arousal (wakefulness) and is hypothesized to play a role in excessive arousal, which occurs in subsets of patients with mood disorders, and to have clinical utility in the treatment of such patients.

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 or JNJ-42847922), in clinical development for insomnia and MDD; MIN-117, in clinical development for major depressive disorder (MDD); and MIN-301, in pre-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

About the Minerva & Janssen collaboration

Minerva is developing seltorexant with Janssen Pharmaceutica, a Johnson & Johnson company. Under the terms of the collaboration, Minerva has exclusive commercialization rights to seltorexant and other orexin molecules for the treatment of insomnia and all other indications including MDD in the Minerva Territory (EU, Iceland, Lichtenstein, Switzerland & Norway). Royalties on sales outside of the Minerva Territory are payable by Janssen. Minerva pays royalties on sales (excluding sales of products for the treatment of insomnia) within the Minerva Territory.

Minerva has no financial obligations for development costs until completion of the Phase 2b development milestone. Minerva has strategic control of matters relating to the clinical development of seltorexant for insomnia.

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 current clinical trials and results of clinical trials with roluperidone, seltorexant, MIN-117 and MIN-301; the timing and scope of future clinical trials and results of clinical trials with these compounds; the clinical and therapeutic potential of these compounds; our ability to successfully develop and commercialize our therapeutic products; the sufficiency of our current cash position to fund our operations; and management’s ability to successfully achieve its goals.  These forward-looking statements are based on our current expectations and may differ materially from actual results due to a variety of factors including, without limitation, whether roluperidone, seltorexant, MIN-117 and MIN-301 will advance further in the clinical trials process and whether and when, if at all, they will receive final approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies and for which indications; whether any of our therapeutic products will be successfully marketed if approved; whether any of our therapeutic product discovery and development efforts will be successful; management’s ability to successfully achieve its goals; our ability to raise additional capital to fund our operations on terms acceptable to us; and general economic conditions.  These and other potential risks and uncertainties that could cause actual results to differ from the results predicted are more fully detailed under the caption “Risk Factors” in our filings with the Securities and Exchange Commission, including our Quarterly Report on Form 10-Q for the quarter ended March 31, 2019, filed with the Securities and Exchange Commission on May 6, 2019.  Copies of reports filed with the SEC are posted on our website at The forward-looking statements in this press release are based on information available to us as of the date hereof, and we disclaim any obligation to update any forward-looking statements, except as required by law.

Contact :

William B. Boni
VP, Investor Relations/
Corp. Communications
Minerva Neurosciences, Inc.
(617) 600-7376

About GlobeNewswire

One Liberty Plaza - 165 Broadway
NY 10006 New York

GlobeNewswire is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.

Subscribe to releases from GlobeNewswire

Subscribe to all the latest releases from GlobeNewswire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from GlobeNewswire

BOURBON: Press release - Update on the search operations of the Bourbon Rhode crew12.10.2019 09:00:00 CESTPress release

Marseilles, October 12, 2019 Update on the search operations of the Bourbon Rhode crew Following the report of a possible distress flare on the night of Sunday 6 to Monday October 7, the CROSS French West Indies-Guyana (Regional Operational Centre for Surveillance and Rescue) dispatched 4 ships to search the area, with the support of an overflight by the US Coast Guards aircraft. Over the past week, search has been intense and extensive to try to detect a sign after on the one hand, the report of this potential distress flare and on the other hand, the satellite photo obtained from the European Maritime Safety Agency (EMSA). These new searches have unfortunately been unsuccessful. As a whole, search operations have not found any trace of life or life rafts for more than 10 days now despite measures of exceptional magnitude. As a reminder, search and rescue operations have been going on for 16 days, with the sinking of the ship taking place on September 26 as it faced hurricane Lorenzo.

Agfa-Gevaert: Publication of a transparency notification (AOC) – Regulated information11.10.2019 17:40:00 CESTPress release

(Article 14 of the law of May 2, 2007 on the disclosure of significant shareholdings) Mortsel, Belgium – October 11, 2019 – 5.40 p.m. CET According to Agfa-Gevaert NV’s bylaws, the threshold as from which a shareholding needs to be disclosed, has been set at 3%, 5% and a multiple of 5%. In conformity with the Law of May 2, 2007 regarding the disclosure of significant shareholdings in listed companies, Agfa-Gevaert (Euronext: AGFB) discloses the following declaration: Active Ownership Capital S.à.r.l. has announced on April 18, 2019, that it managed a stake in Agfa-Gevaert as per April 12, 2019 of 23,069,853 voting rights or 13.42% (denominator is 171,851,042). On this date, AOC Value S.A.S. individually held 13,402,784 voting rights or 7.80%. On April 12, 2019, Active Ownership Fund SICAV-FIS SCS contributed 4,535,000 shares already held by it in Agfa-Gevaert NV to AOC Technology S.A.S., as a result of which AOC Technology S.A.S. directly holds 9,667,069 voting rights or 5.63% of Agfa-

DNO ASA: Mandatory Notification of Trade11.10.2019 16:56:00 CESTPress release

Oslo, 11 October 2019 - DNO ASA, the Norwegian oil and gas operator, has today purchased 1,900,000 own shares at an average price of NOK 13.0887 per share. Following this transaction, DNO holds 73,200,000 own shares. -- For further information, please contact: Media: Investors: -- DNO ASA is a Norwegian oil and gas operator focused on the Middle East and the North Sea. Founded in 1971 and listed on the Oslo Stock Exchange, the Company holds stakes in onshore and offshore licenses at various stages of exploration, development and production in the Kurdistan region of Iraq, Norway, the United Kingdom, Netherlands, Ireland and Yemen. This information is subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.

PRF: Unaudited preliminary consolidated turnover of AS PRFoods in the 3rd quarter of 201911.10.2019 16:28:00 CESTPress release

PRFoods’ unaudited preliminary consolidated turnover in 3Q 2019 (i.e. 1Q of the fiscal year 2019/2020) amounted to EUR 19.32 million euros (19.40 million euros in 3Q 2018). The third quarter of 2019 was characterized by a general decline of raw material prices for fish products, resulting in lower prices for both fish and fish fillets, and smoked products. Despite the ca 5% decrease in the price of the Group’s main products, we managed to increase the share of other fish products and keep the total turnover largely at the level of last year. The turnover of other fish products increased by 1.01 million euros, whereas turnover from smoked fish product group and raw fish and fillets’ product group decreased by 0.54 million euros and 0.48 million euros, respectively. The Group’s revenue structure has changed both in regard to product groups as well as client groups compared to the same period a year ago. The share of other fish products increased by 5.30 percentage points. The share of ra

Conditions for Inflation-linked auctions11.10.2019 16:20:00 CESTPress release

Sveriges Riksbank Bid procedure details Inflation-linked Government Bonds, 2019-10-18 Maturity date Loan ISIN code Coupon Volume, SEK million 2026-06-01 3112 SE0008014062 0.125 % 250 +/- 250 2028-12-01 3104 SE0000556599 3.50 % 250 +/- 250 Settlement date 2019-10-22 Bids have to be entered by 10.00 on OCT 18, 2019 Highest permitted bid volume: 250 SEK million Lowest permitted bid volume: 50 SEK million Bids only through counterparties approved by the Riksbank RESULT OF AUCTION WILL BE PUBLISHED NO LATER THAN 10.10 (CEST) ON OCT 18, 2019. For more information, please contact: Trading desk at the Riksbank + 46 8 696 6970 General and special terms and conditions can be retrieved at

Conditions for Riksbank Bid Procedures Sek Bonds11.10.2019 16:20:00 CESTPress release

Sveriges Riksbank Bid procedure details Government Bonds, 2019-10-17 Maturity date Loan ISIN code Coupon Volume, SEK million 2023-11-13 1057 SE0004869071 1.50 % 500 +/- 250 2029-11-12 1061 SE0011281922 0.75 % 500 +/- 250 Settlement date 2019-10-21 Bids have to be entered by 10.00 on OCT 17, 2019 Highest permitted bid volume: 500 SEK million in issue SGB 1057 and 500 SEK million in issue SGB 1061 Lowest permitted bid volume: 50 SEK million Bids only through counterparties approved by the Riksbank RESULT OF AUCTION WILL BE PUBLISHED NO LATER THAN 10.10 (CEST) ON OCT 17, 2019. For more information, please contact: Trading desk at the Riksbank + 46 8 696 6970 General and special terms and conditions can be retrieved at