Nasdaq GlobeNewswire

American Journal of Psychiatry Publishes Minerva Neurosciences' MIN-101 Phase 2b Trial Results for Treatment of Negative Symptoms in Schizophrenia

Del

WALTHAM, Mass., July 31, 2017 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ:NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system disorders, today announced that the American Journal of Psychiatry has published online results from its previously reported Phase 2b clinical trial of MIN-101. MIN-101 is a novel compound with affinities for sigma2 and 5HT2A receptors but no direct activity on dopamine receptors. In this regard, MIN-101 differs from drugs currently indicated for schizophrenia, all of which directly interfere with dopamine neurotransmission by antagonizing dopamine receptors.

The manuscript, entitled "Efficacy and Safety of MIN-101: A 12-Week Randomized, Double-Blind, Placebo-Controlled Trial of New Drug in Development for the Treatment of Negative Symptoms in Schizophrenia," and be found online at http://www.medical-reprints.com/US-MN-AJP-Davidson.

The key finding from the publication is that MIN-101 achieved its primary outcome in the trial, demonstrating statistically significant superiority over placebo in improving negative symptoms in schizophrenia patients as measured by the pentagonal negative symptoms cluster of the Positive and Negative Syndrome Scale (PANSS). The improvement in negative symptoms was shown for both doses tested: 32 milligrams (mg): p = 0.024 effect size = 0.45, and 64 mg: p = 0.004 effect size = 0.57. 

Supporting these findings were similar and concomitant improvements on several secondary outcome measures, including PANSS cluster analyses of negative symptoms, the PANSS total score, the Clinical Global Impression (CGI) and the Brief Negative Symptom Scale (BNSS). Psychosis measured by the PANSS Positive symptoms subscale remained stable during the trial, suggesting that the improvement in negative symptoms associated with MIN-101 was specific and not a pseudo-effect secondary to improvements in psychosis.  

MIN-101 also demonstrated good tolerability, with no weight gain or other metabolic abnormalities, no clinically significant changes in vital signs, routine laboratory values, sedation and extra-pyramidal symptoms (EPS).   The lack of observed adverse effects associated with MIN-101 treatment as compared to placebo helped to preserve the blinding of the trial, further supporting the validity and specificity of the improvement observed in negative symptoms. 

"Negative symptoms, which tend to persist even after psychosis improves, are the main impediment to social reintegration of schizophrenia patients," said Dr. Philip D. Harvey, Leonard M. Miller Professor of Psychiatry and Director of the Division of Psychology at the University of Miami Miller School of Medicine and an expert in the rehabilitation of schizophrenia patients. "No drugs in the U.S. are currently indicated for negative symptoms in schizophrenia, and a drug with specific effects on negative symptoms has a real chance to improve the day-to-day social and vocational functioning of patients affected by this disease."

"The findings published in the American Journal of Psychiatry are noteworthy in that MIN-101 was shown to improve negative symptoms without blocking dopamine receptors, unlike other drugs indicated for schizophrenia," said Dr. Harvey.  "As such, it may be better tolerated by patients and may improve drug adherence, which is particularly problematic in treating schizophrenia."  Dr. Harvey was not involved in the design or the conduct of the Phase 2b trial with MIN-101.

"The publication of these data by a prestigious journal like the American Journal of Psychiatry is important for Minerva because it reflects a peer-reviewed recognition by the scientific and medical community of a new and innovative potential approach to alleviating the most debilitating symptoms in patients suffering from schizophrenia," said Dr. Remy Luthringer, president and chief executive officer of Minerva.

Following a recent "end-of-Phase 2" meeting with the U.S. Food and Drug Administration (FDA), Minerva expects to initiate a pivotal Phase 3 trial with MIN-101 to treat negative symptoms in schizophrenia in the second half of 2017. 

About the American Journal of Psychiatry

The American Journal of Psychiatry is the official journal of the American Psychiatric Association (APA), the oldest medical association in the country, founded in 1844. It is published monthly and is focused on a broad spectrum of issues and advances in the diagnosis and treatment of mental illness.  The APA is the largest psychiatric association in the world with more than 37,000 physician members specializing in the diagnosis, treatment, prevention and research of mental illness. 

About Minerva Neurosciences

Minerva Neurosciences, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of a portfolio of products to treat CNS diseases.  Minerva's proprietary compounds include: MIN-101, in clinical development for schizophrenia; MIN-202 (JNJ-42847922), in clinical development for insomnia and major depressive disorder (MDD); MIN-117, in clinical development for 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 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 results of future clinical milestones with MIN-101, including the planned Phase 3 trial of MIN-101, the timing and scope of future clinical trials and results of clinical trials with this compound; the timing and outcomes of future interactions with U.S. and foreign regulatory bodies; our ability to successfully develop and commercialize MIN-101; 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 MIN-101 will advance further in the clinical trials process and whether and when, if at all, it will receive final approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies and for which indications; whether the results of future clinical trials of MIN-101, if any, will be consistent with the results of past clinical trials; whether MIN-101 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, 2017, filed with the Securities and Exchange Commission on May 4, 2017.  Copies of reports filed with the SEC are posted on our website at  www.minervaneurosciences.com . 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




This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Minerva Neurosciences, Inc. via Globenewswire

Om Nasdaq GlobeNewswire

Nasdaq GlobeNewswire
Nasdaq GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York

+1 212 401 8700http://www.nasdaqomx.com

NASDAQ (NASDAQ: NDAQ) is a leading provider of trading, exchange technology, information and public company services across six continents.

Følg saker fra Nasdaq GlobeNewswire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Nasdaq GlobeNewswire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Nasdaq GlobeNewswire

Euroloan Opens New Market in Spain23.11.2017 11:10Pressemelding

Helsinki, Finland, 2017-11-23 11:10 CET (GLOBE NEWSWIRE) -- According to James Hickson, CEO of Euroloan Group, initiating services in the Spanish market is a key step in the expansion strategy of the Fintech group. “We have seen a growing demand for easy payment solutions in several markets, and the Spanish market in particular offers a massive opportunity for growth with Euroloan’s advanced payment and credit solutions. Merchants and Consumers appreciate our simple, fast and efficient services. It’s all about making their life easier. Consistent with our strategy, we have identified a number of partners to accelerate our market entry approach and expect to be providing our lending and merchant solutions by the end of the 1Q 2018” The Group is now present in five countries in Europe, including Finland, Sweden, Poland, Luxembourg and Spain. “Euroloan aims to open up several additional new markets”, says Tommi Lindfors, Chairman of the Board of Euroloan Group. “Spain is an importan

BDA partners with government to attract cryptocurrency23.11.2017 06:25Pressemelding

HAMILTON, Bermuda, Nov. 23, 2017 (GLOBE NEWSWIRE) -- The Bermuda Business Development Agency (BDA) will take a lead role in an initiative launched by the Bermuda government today to accelerate the establishment and growth of digital currency business on the island. A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/457f43b9-d7bb-48f1-83e2-b856b33ebacc At a press conference held by Premier the Hon David Burt and National Security Minister the Hon Wayne Caines, the government announced the formation of a task force comprising two teams to advance Bermuda's regulatory environment as a destination for utility tokens, tokenised securities, cryptocurrencies, and coin offerings. BDA Consultant for Emerging Technologies John Narraway was named as chair of the Blockchain Business Development Working Group, while BDA Board member Lydia Dickens will chair the Blockchain Legal and Regulatory Working Group, of which

VistaJet Partners With Christie's for the Global Tour of The Collection of Peggy and David Rockefeller22.11.2017 11:39Pressemelding

The sale will be the most significant philanthropic auction ever presented LONDON, Nov. 22, 2017 (GLOBE NEWSWIRE) -- VistaJet, the first and only global private aviation company, announces today its worldwide sponsorship of the exhibition and tour of The Collection of Peggy and David Rockefeller, the most significant auction entirely dedicated to raising funds for philanthropic causes.  The sale, consisting of numerous categories, will be conducted by Christie's, the world's leading art business, and will include a highlights exhibition tour in Hong Kong, London, Los Angeles and New York. Photos accompanying this announcement are available at http://www.globenewswire.com/NewsRoom/AttachmentNg/c78fdce7-7651-42a8-a621-14088da2cc86 http://www.globenewswire.com/NewsRoom/AttachmentNg/33af2489-a9a8-4bbe-b5f7-78e4c1f29ca2 http://www.globenewswire.com/NewsRoom/AttachmentNg/a16c2

Nasdaq to Deliver Blockchain e-Voting Solution to Strate22.11.2017 10:00Pressemelding

South Africa's central securities depository (CSD) will leverage the solution to improve voting efficiencies and increase shareholder participation in South Africa STOCKHOLM, Sweden and JOHANNESBURG, South Africa, Nov.  22, 2017  (GLOBE NEWSWIRE) -- Nasdaq (Nasdaq:NDAQ) and Strate (Pty) Ltd, the South African CSD, announced today an agreement for Nasdaq to deliver a new blockchain solution that would bring electronic voting to the South African capital markets. The solution will allow Strate, in conjunction with key stakeholders in the market, to provide general meeting services and give shareholders an easy, user-friendly and secure tool for voting remotely. The solution is based on the successful proof of concept (PoC) developed for Nasdaq's Estonia market. In addition, Strate will contribute to the ongoing market development of e-Voting technology. "We are very excited about our initiative with Nasdaq and what it means for the South African financial markets," said Tan

Oxford Immunotec to Present at the 29th Annual Piper Jaffray Healthcare Conference21.11.2017 15:15Pressemelding

OXFORD, United Kingdom and MARLBOROUGH, Mass., Nov. 21, 2017 (GLOBE NEWSWIRE) -- Oxford Immunotec Global PLC (Nasdaq:OXFD), a global, high-growth diagnostics company focused on developing and commercializing proprietary tests for the management of underserved immune-regulated conditions, today announced that Peter Wrighton-Smith, Chief Executive Officer, will present at the 29th Annual Piper Jaffray Healthcare Conference on Tuesday, November 28th, at 12:00 p.m. EST. The conference will be held at the Lotte New York Palace. A live webcast of the presentation will be available online from the investor relations page of the Company's corporate website at www.oxfordimmunotec.com. A webcast replay will be available approximately two hours after the live presentation and will be archived on the website for approximately 90 days. About Oxford Immunotec Oxford Immunotec Global PLC is a global, high-growth diagnostics company focused on developing and comme

CrownBio's Translatable FATZO Model Utilized in Eli Lilly's Preclinical Type 2 Diabetes Research Programs21.11.2017 14:00Pressemelding

SANTA CLARA, Calif., Nov. 21, 2017 (GLOBE NEWSWIRE) -- Crown Bioscience, a wholly-owned subsidiary of Crown Bioscience International (TWSE: ticker 6554) and a global drug discovery and development services company providing translational platforms to advance oncology, inflammation, cardiovascular and metabolic disease research, announces the publication of two new papers. These joint publications illustrate the utility of Crown Bioscience's proprietary FATZO model as a model for obesity and type 2 diabetes in preclinical studies. The research conducted by Crown Bioscience, Eli Lilly and Company and Ball State University was published in two PLOS ONE papers: Peterson et al. Glucose dysregulation and response to common anti-diabetic agents in the FATZO/Pco model PLOS One 2017;12 (6):e0179856, https://doi.org/10.1371/journal.pone.0179856  Droz et al. Correlation of disease severity with body weight and high fat diet in the FATZO/Pco model PLOS One 2017;1

I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.

Besøk vårt presserom