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WALTHAM, Mass., June 24, 2019 (GLOBE NEWSWIRE) — Minerva Neurosciences, Inc. (NASDAQ: NERV), a clinical-stage biopharmaceutical aggregation focused on the development of therapies to amusement axial afraid arrangement (CNS) disorders, today appear after-effects of a analytic balloon (ISM2005) of seltorexant (MIN-202) in patients with indisposition ataxia that approved awful statistically cogent (p ≤0.001) and clinically allusive beforehand on LPS at Night 1, the primary endpoint of the study. The beggarly abatement from baseline at Night 1 in LPS was 15 account for placebo, 30 account for seltorexant 5 mg, 50 account for seltorexant 10 mg, and 48 account for seltorexant 20 mg.

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For the key accessory endpoint, WASO-6 at Night 1, the beggarly beforehand from baseline at Night 1 was 15 account for placebo, 23 account for seltorexant 5 mg, 43 account for 10 mg, and 45 account for 20 mg of seltorexant. Furthermore, assorted accessory endpoints were additionally bigger against placebo and accepted of affliction zolpidem, which is accessible beneath the cast name Ambien.

Additional capacity are provided below.

“The allegation from this abstraction authenticate that seltorexant decidedly improves beddy-bye consecration and prolongs beddy-bye duration,” said Professor Thomas Roth, Director of the Beddy-bye Disorders and Research Center at Henry Ford Hospital.  “The after-effects additionally authenticate that seltorexant showed a decidedly greater beforehand in these beddy-bye ambit compared to zolpidem.

“In addition, the benign furnishings on LPS and WASO of seltorexant on age-old patients in the study, in affiliation with a favorable tolerability profile, beforehand its abeyant account in the ample and growing citizenry of age-old patients whose prevalence of indisposition is college than in adolescent patients, appropriately apery an important ameliorative option,” said Professor Roth.

Professor David Kupfer, Distinguished Professor Emeritus of Psychiatry at the University of Pittsburgh School of Medicine and lath affiliate of Minerva, said, “Based on these after-effects and those from the contempo MDD2001 study, observations of seltorexant accommodate a clinically allusive beforehand in affection of abasement in patients not responding abundantly to aboriginal band therapies (SSRIs and SNRIs) and a clinically allusive aftereffect on indisposition in a advanced age ambit of patients.

“The affirmation of a cogent account beyond a ample spectrum of patients who ache with abasement and/or indisposition and who accept not responded abundantly to absolute therapies credibility to a differentiated analytic contour and a new way to abode an underserved accommodating population” added Professor Kupfer.

“Seltorexant is a specific orexin-2 adversary (SORA) rather than a bifold orexin receptor adversary (DORA) and appropriately has a differentiated apparatus of activity that may advice abode abundant psychiatric disorders,” said Dr. Remy Luthringer, Executive Chairman and Chief Executive Officer of Minerva. “Unlike absolute therapies, seltorexant is advised to actor the accustomed beddy-bye action by inhibiting the academician mechanisms that beforehand boundless indisposition rather than by sedating patients through the activation of the neurotransmitters that beforehand sleep.”

About the ISM 2005 balloon

Study design:

This multicenter, appearance 2b, double-blind, randomized, parallel-group, active- and placebo-controlled, 17‑day (2 weeks of alive treatment) dosage award abstraction was advised to appraise the adeptness and assurance of seltorexant in both developed (18 to 64 years old) and age-old (65 to 85 years old) capacity with indisposition ataxia afterwards psychiatric co-morbidity. The abstraction enrolled a absolute cardinal of 365 subjects, randomized in a 1:1:1:1:1 arrangement to accept one of 5 treatments: placebo, seltorexant 5 mg, seltorexant 10 mg, seltorexant 20 mg and zolpidem (5 or 10 mg based on the bounded label). The randomization was stratified by arena (United States/Europe and Japan) and age accumulation (adult and elderly).

Efficacy was evaluated at Night 1 (first biologic administration) and afterwards 2 weeks of biologic administering (Night 13). Assurance was evaluated throughout the abstraction duration.

Polysomnography (PSG), an cold admeasurement of sleep, was acclimated to appraise the aftereffect of seltorexant, placebo and zolpidem.

Primary and accessory objectives:

The primary cold was to appraise the dose-response of three doses of seltorexant (5, 10 and 20 mg daily) compared to placebo application the primary endpoint, beddy-bye admission as abstinent by LPS by PSG at Night 1 (first biologic administration). 

The key accessory cold was to appraise the aftereffect of seltorexant on the key accessory endpoint, WASO-6 by PSG at Night 1.

Other accessory objectives included:

Overall assurance and tolerability were evaluated throughout the abstraction duration.

Both developed (18 to <65 years of age) and age-old (65 to 85 years of age) patients accept been included in the abstraction in acclimation to bigger accept age abased adeptness and tolerability of seltorexant and zolpidem.

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Ford Territory 2020
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Statistics:

The primary adeptness endpoint, LPS, was evaluated at a 1-sided acceptation akin of 0.05 application the MCP‑Mod (Multiple Comparison Procedure-Modeling) admission to assay for dose-response. For all absolute statistical analyses of the primary adeptness endpoint and for all added accessory adeptness endpoints, alloyed archetypal for again measures (MMRM) or assay of covariance (ANCOVA) with no complication acclimation were performed. The primary and key accessory endpoints were log‑transformed afore the statistical assay application ANCOVA/MMRM models. For all analyses added than MCP-Mod, 2‑sided p-values are presented. Back assay comparisons resulted in cogent p‑values (p ≤0.050), these are additionally presented below.

The pre-specified comparisons to zolpidem on both endpoints and the all-embracing assurance and tolerability are additionally included. 

Results:

Of the 364 capacity that accustomed abstraction drugs, 32.4% were male. The beggarly (SD) age was 57.8 (SD = 12.4) years, alignment from 22 to 84 years.  Capacity had a beggarly absolute indisposition severity Index (ISI) account of 20.2 at baseline, apocalyptic of abstinent to astringent insomnia.

Primary endpoint:

All 4 pre-specified dose-response models showed a cogent dose-response accord in LPS at Night 1, area the adapted 1-sided p-values were <0.001.

There was a cogent break from placebo of the 10 mg and 20 mg dosage groups.  The advantage in atomic squares (LS) beggarly on changes from baseline of the seltorexant dosage groups over placebo at Night 1 were: 16.4 account for the 5 mg, 32.2 account for the 10 mg (p ≤0.001), and 36.6 account for the 20 mg (p ≤0.001).  Advantages over placebo were additionally empiric at Night 13: 5.2 account for the 5 mg, 28.6 minutes for the 10 mg (p ≤0.001), and 21.0 account for the 20 mg (p ≤0.001).

Secondary endpoints:

WASO-6 at Night 1 showed an advantage in LS beggarly on change from baseline of the seltorexant dosage groups over placebo of: 14.6 account for the 5 mg, 28.6 account for the 10 mg (p ≤0.005), and 28.6 minutes for the 20 mg (p ≤0.001).  Advantages over placebo were additionally empiric at Night 13: 6.5 minutes for the 5 mg, 16.1 account for the 10 mg, and 21.5 account for the 20 mg (p ≤0.002).

WASO-6 was called as the key accessory endpoint back seltorexant has a abbreviate half-life, and in antecedent studies some capacity awoke afterwards 6-7 hours and did not feel the charge for added sleep. Moreover, WASO-6 is generally advised to be a clinically accordant admeasurement in beddy-bye trials, back alive adults frequently do not accept to abide in bed comatose for an absolute 8-hour period.

Seltorexant 20 mg showed a greater beforehand compared to zolpidem for LPS at both Night 1 (10.5 minutes, p ≤0.010) and Night 13 (12.1 minutes, p ≤0.036), while 10 mg alone afar at Night 13 (19.6 minutes, p ≤0.021). For WASO-6, the 20 mg dosage showed decidedly greater beforehand compared to zolpidem at Night 13 (11.6 minutes, p ≤0.019). Zolpidem absolute absolution (IR), which was administered as 5 or 10 mg according to the country-by-country label, was called as alive comparator and showed ahead to placebo for both LPS and WASO-6 at Night 1 but not Night 13, demonstrating a accepted abatement of aftereffect of zolpidem over time.

Analyses of the LPS and WASO-6 were additionally performed by subgroups, including age (adults and elderly), and all-embracing these analyses were constant with the primary analysis. Additionally, the LPS after-effects were agnate amid the 2 age subgroups. WASO-6 had a bigger acknowledgment in the age-old (all 3 doses decidedly afar from placebo) compared to the developed citizenry (only the 20 mg accumulation decidedly afar from placebo).

Similar to antecedent analytic trials, seltorexant showed a adequate assurance and tolerability contour in both developed and age-old patients. All-embracing seltorexant was able-bodied tolerated, with treatment-emergent adverse contest (TEAEs) agnate to those empiric in antecedent studies. The all-embracing accident of adverse contest in the seltorexant assay accoutrements was low (33.8% in the accumulated seltorexant group, with 40.3% in the 5 mg group, 31.5% in the 10 mg accumulation and 29.6% in the 20 mg group) and was lower than the amount empiric in the placebo accumulation (49.3%) and zolpidem accumulation (42.5%). Most TEAEs were balmy to abstinent in acuteness and bound afterwards sequelae.

Conference Alarm Information:

Minerva Neurosciences will authority a appointment alarm and alive audio webcast on June 24, 2019 at 8:30 a.m. Eastern Time to altercate the after-effects of this trial.  To participate, amuse punch (877) 312-5845 (domestic) or (765) 507-2618 (international) and accredit to appointment ID 1644578.  To admission the webcast, amuse go to https://engage.vevent.com/rt/minervaneurosciencesinc~062419.

The alive webcast can additionally be accessed beneath “Events and Presentations” in the Investors and Media area of Minerva’s website at ir.minervaneurosciences.com.  The archived webcast will be accessible on the website alpha about two hours afterwards the accident for 90 days.

About Seltorexant (MIN-202)

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Seltorexant is a careful orexin-2 receptor adversary beneath co-development by Janssen Pharmaceutica N.V., a Pharmaceutical Aggregation of Johnson & Johnson, and Minerva as accessory analysis for MDD and for the assay of indisposition disorder. The orexin arrangement in the academician is complex in the ascendancy of several key functions, including metabolism, accent acknowledgment and wakefulness. This arrangement promotes activation (wakefulness) and is accepted to comedy a role in boundless arousal, which occurs in patients with indisposition and in subsets of patients with affection disorders, and to accept analytic account in the assay of such patients.

About Insomnia

According to the American Academy of Beddy-bye Medicine, about 30-35% of adults accept abrupt affection of insomnia, 15-20% accept concise indisposition ataxia (lasting beneath than three months), and 10% accept abiding insomnia, which occurs at atomic three times per anniversary for at atomic three months.1  Indisposition incurs a cogent bread-and-butter amount on society, with estimates of $63.2 billion in absent productivity.2

Chronic indisposition can accept a abrogating appulse on bloom and can be a accepted comorbidity of abounding medical conditions, including diabetes, coronary affection disease, abiding adverse pulmonary disease, arthritis, fibromyalgia and added abiding affliction conditions.  Individuals with indisposition ataxia frequently accept a comorbid brainy disorder, including depressive and all-overs disorders.3

Age and gender are acutely articular demographic accident factors for insomnia, with an added prevalence in women and earlier adults. Indisposition is frequently apparent in age-old populations and is associated with adverse after-effects for acknowledged aging.4  Beddy-bye disturbances amid the age-old are associated with cogent anguish and bloodshed and access the accident for nursing home placement.  These allegation are decidedly accordant as the citizenry of bodies age-old 65 years or earlier continues to grow.

About Minerva Neurosciences

Minerva Neurosciences, Inc. is a clinical-stage biopharmaceutical aggregation focused on the development and commercialization of a portfolio of artefact candidates to amusement CNS diseases.  Minerva’s proprietary compounds include: roluperidone (MIN-101), in analytic development for schizophrenia; seltorexant (MIN-202 or JNJ-42847922), in analytic development for indisposition and Major Depressive Ataxia (MDD); MIN-117, in analytic development for MDD; and MIN-301, in pre-clinical development for Parkinson’s disease.  Minerva’s accepted banal is listed on the NASDAQ Global Market beneath the attribute “NERV.”  For added information, amuse appointment http://www.minervaneurosciences.com.

About the Minerva & Janssen collaboration

Minerva is developing seltorexant with Janssen Pharmaceutica N.V., a Pharmaceutical Aggregation of Johnson & Johnson. Beneath the agreement of the collaboration, Minerva has absolute commercialization rights to seltorexant and added orexin molecules for the assay of indisposition and all added break including MDD in the Minerva Territory (EU, Iceland, Lichtenstein, Switzerland & Norway). Royalties on sales alfresco of the Minerva Territory are payable by Janssen. Minerva pays royalties on sales (excluding sales of articles for the assay of insomnia) aural the Minerva Territory.

Forward-Looking Safe Anchorage Statement

This columnist absolution contains advanced statements which are accountable to the safe anchorage accoutrement of the Private Securities Litigation Reform Act of 1995, as amended.  Advanced statements are statements that are not absolute facts, reflect management’s expectations as of the date of this columnist release, and absorb assertive risks and uncertainties.  Advanced statements accommodate statements herein with account to the timing and ambit of accepted analytic trials and after-effects of analytic trials with roluperidone, seltorexant, MIN-117 and MIN-301; the timing and ambit of approaching analytic trials and after-effects of analytic trials with these compounds; the analytic and ameliorative abeyant of these compounds; our adeptness to auspiciously beforehand and commercialize our ameliorative products; the capability of our accepted banknote position to armamentarium our operations; and management’s adeptness to auspiciously accomplish its goals.  These advanced statements are based on our accepted expectations and may alter materially from absolute after-effects due to a array of factors including, afterwards limitation, whether roluperidone, seltorexant, MIN-117 and MIN-301 will beforehand added in the analytic trials action and whether and when, if at all, they will accept final approval from the U.S. Food and Biologic Administering or agnate adopted authoritative agencies and for which indications; whether any of our ameliorative articles will be auspiciously marketed if approved; whether any of our ameliorative artefact analysis and development efforts will be successful; management’s adeptness to auspiciously accomplish its goals; our adeptness to accession added basic to armamentarium our operations on agreement adequate to us; and accepted bread-and-butter conditions.  These and added abeyant risks and uncertainties that could account absolute after-effects to alter from the after-effects predicted are added absolutely abundant beneath the explanation “Risk Factors” in our filings with the Securities and Exchange Commission, including our Quarterly Report on Form 10-Q for the division ended March 31, 2019, filed with the Securities and Exchange Commission on May 6, 2019.  Copies of letters filed with the SEC are acquaint on our website at www.minervaneurosciences.com. The advanced statements in this columnist absolution are based on advice accessible to us as of the date hereof, and we abandon any obligation to amend any advanced statements, except as appropriate by law.

1http://sleepeducation.org/news/2014/03/10/insomnia-awareness-day-facts-and-stats

2https://aasm.org/insomnia-costing-u-s-workforce-63-2-billion-a-year-in-lost-productivity-study-shows/

3https://www.ncbi.nlm.nih.gov/books/NBK19961/

4https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1978319/

Contact:

William B. BoniVP, Investor Relations/Corp. CommunicationsMinerva Neurosciences, Inc.(617) 600-7376

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Ford Territory 2020
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