Nasdaq GlobeNewswire

Minerva Neurosciences Announces Positive Data From Six-Month Extension of Phase IIb Trial of MIN-101 Monotherapy in Schizophrenia

Del

WALTHAM, Mass., Oct. 26, 2016 (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 data from the 24-week open-label extension of its 12-week, randomized, double-blind, placebo-controlled Phase IIb clinical trial of MIN-101 as monotherapy in patients with negative symptoms of schizophrenia. Data from the 12-week core phase of this trial were reported in May of this year.

Graphic representations of the data summarized below are available at http://ir.minervaneurosciences.com/events.cfm and contained in the Current Report on Form 8-K filed by Minerva on October 26, 2016. 

“Data from the extension phase demonstrate a further and continuous improvement in negative symptoms in patients with schizophrenia, as measured by the negative symptom subscales of the Positive and Negative Syndrome Scale (PANSS),” said Dr. Remy Luthringer, president and chief executive officer of Minerva. “The longer patients were on monotherapy with MIN-101, the greater improvement they were observed to experience in their negative symptoms during the entire extension period, without evidence of reaching a plateau. We believe that such continuous improvement in symptoms over a nine month period in this patient population is unprecedented. 

“The data also provide an extended safety profile for MIN-101 consistent with that observed during the core double-blind phase of the trial,” said Dr. Luthringer.  “MIN-101 was reported to be well tolerated at both doses over the entire 36-week duration of the study by schizophrenic patients.  In addition, positive symptoms were observed to remain stable through the extension period as measured by the PANSS positive symptom subscale score. Improvements in overall schizophrenic psychopathology were also observed, as measured by the PANSS general psychopathology subscale and the total PANSS score.

“We believe these exciting data point the way toward pivotal testing of MIN-101 as a novel, differentiated treatment for the large worldwide population of patients with schizophrenia for whom negative symptoms contribute substantially to poor quality of life and functional outcomes,” said Dr. Luthringer.

Results announced earlier this year from the double-blind, placebo-controlled 12-week core phase of the trial showed that it met its primary endpoint of statistically significant improvement in negative symptoms as measured by the PANSS pentagonal structure model (PSM), and showed statistically significant benefit in multiple secondary endpoints that included general psychopathology and cognition. 

Patients who completed the core phase were provided the opportunity to enter into a 24-week, open-label extension phase.  During the extension phase, all patients received either 32 milligrams (mg) or 64 mg of MIN-101.  Patients who received placebo in the core phase were randomized to one of these two doses at the beginning of the extension phase.  Data generated during the extension period were intended to provide longer term supportive evidence of efficacy and to complement the statistically significant results obtained during the core phase.

One hundred forty-two patients from the treatment and placebo groups in the core phase entered the extension phase, with 88 patients completing the extension.   Seventy patients received 32 mg and 72 patients received 64 mg during the extension. 

Negative symptoms, assessed based on the PANSS PSM, were observed to continue to improve during the extension phase, as shown by a reduction from the study start for the 32 and 64 mg-treated groups of 5.5 points and 4.9 points, respectively, and by a reduction of 5.4 points and 5.3 points, respectively, in the PANSS three factors negative symptoms subscale.  Reductions over time of PANSS negative PSM scores are shown in the attached graph.

http://www.globenewswire.com/NewsRoom/AttachmentNg/a29ffbc7-ffb5-4dd6-af4e-f042defb88d5

Positive symptoms were observed to remain stable throughout the study, as measured by PANSS positive symptom scores. This finding is consistent with the hypothesis that MIN-101 has a direct and specific effect on negative symptoms.

General psychopathology was observed to improve during the extension phase for the 32 and 64 mg groups, as shown by reductions in the PANSS general psychopathology subscale score and total PANSS score.

MIN-101 was generally reported to be well tolerated through the entire 36-week period.  QTcF, a measurement of cardiac function, was closely monitored throughout the study, and discontinuation criteria based on QTcF prolongation were incorporated in the protocol.  As previously announced, two patients out of 162 who received MIN-101 in the core phase were discontinued based upon these criteria; both of these patients received the higher dose (64 mg). In the extension phase no additional patients were discontinued.  The extension data also confirm that MIN-101 at the doses tested did not have an effect on extra-pyramidal symptoms (EPS), prolactin or weight gain.

About MIN-101

MIN-101 is a drug candidate with equipotent affinities for sigma 2 and 5‑hydroxytryptamine-2A (5-HT2A) and lower affinity at α1-adrenergic receptors. MIN-101 has no direct dopaminergic post-synaptic blocking effects, known to be involved in some side effects like extrapyramidal symptoms, sedation, prolactin increases and weight gain.

About Schizophrenia and Negative Symptoms
As described by the National Institute of Mental Health, schizophrenia is a chronic and severe disorder that affects how a person thinks, feels and acts1.  In 2015 approximately 3.2 million people suffered from schizophrenia in the U.S., Japan and the five major European markets.  Schizophrenic patients suffer from positive, negative and cognitive symptoms.  Negative symptoms are disruptions to normal emotions and behaviors that may signal social withdrawal.  Patients may be socially inhibited, lack the ability to begin and sustain planned activities, or speak little even when forced to interact.  Negative symptoms account for a substantial portion of the morbidity associated with schizophrenia2.  They persist chronically throughout an individual patient’s lifetime and increase with severity over time.

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, which recently completed a Phase IIb clinical trial for schizophrenia; MIN-117, which recently completed a Phase IIa clinical trial development for MDD;  MIN-202 (JNJ-42847922), which recently completed Phase IIa and Phase Ib clinical trials for insomnia and MDD, respectively; 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; the clinical and therapeutic potential of MIN-101; our ability to successfully develop and commercialize MIN-101; 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 our therapeutic product discovery and development efforts with MIN-101 will be successful; our ability to achieve the results contemplated by our co-development agreements; 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 June 30, 2016, filed with the Securities and Exchange Commission on August 4, 2016.  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.

1 https://www.nimh.nih.gov/health/publications/schizophrenia-booklet-12-2015/index.shtml

2 Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, American Psychiatric Association.

 

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

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

GSV Asset Management Announces Strategic Investment from HMC Capital-Led Group14.12.2017 21:03Pressemelding

WOODSIDE, Calif. and NEW YORK, Dec. 14, 2017 (GLOBE NEWSWIRE) -- GSV Asset Management, LLC ("GSV"), a modern merchant bank that identifies, advises, and invests in the fastest growing, most dynamic companies in the world - the Stars of Tomorrow - today announced a strategic investment from a group led by HMC Capital ("HMC"), a leading Latin American advisory and investment firm. While terms of the deal were not disclosed, the investment will result in a minority ownership interest for the HMC-led group in GSV Asset Management. Proceeds will be used to enhance GSV's ongoing investment activities, as well as to accelerate its strategic expansion into new business areas and geographies. "We are very excited to partner with HMC Capital, a multi-billion dollar asset manager that brings a range of complimentary capabilities to GSV Asset Management," said Michael Moe, founder of GSV. "GSV stands for Global Silicon Valley and our alliance with HMC reflects our shared commitment t

TrueCommerce Datalliance Releases Third 2017 Update for Vendor Managed Inventory Platform14.12.2017 19:28Pressemelding

Latest Software Update Enhances Browser, Productivity Experience CINCINNATI, Dec. 14, 2017 (GLOBE NEWSWIRE) -- TrueCommerce Datalliance, a leading vendor managed inventory service solutions provider, announced today that it released the third scheduled 2017 update to its VMI platform. The free update is part of TrueCommerce Datalliance's commitment to improving the functionality of its cloud-based supply chain software. Highlights of the release include several improvements to its system architecture and capabilities: Google Chrome is now officially supported Order Worksheets are now easier to view in Internet Explorer One-click access to recently changed or added items Mass Launch Order Preview lists all items suggested or added via allocation "We promise our customers three major updates every year," said Connie Shafer, TrueCommerce Datalliance Producti

ATTO announces support for Apple® Release of the new iMac Pro14.12.2017 18:37Pressemelding

ATTO's line of ThunderboltTM technology enabled products continue to revolutionize connectivity to storage AMHERST, N.Y., Dec. 14, 2017 (GLOBE NEWSWIRE) -- ATTO Technology, Inc., a global leader of storage and network connectivity and infrastructure solutions for data-intensive computing environments, today confirmed their continued commitment to the newly released line of product updates and innovations from Apple. With the powerful and new iMac Pro® now shipping, ATTO continues to support the new offerings from this industry leading manufacturer. "Our deep relationship with Apple over the last 30 years continues to drive our position as a leading force within the Apple community," said Timothy J. Klein, president and CEO at ATTO Technology. The iMac Pro sets a new standard for Apple design and performance and complements why users select ATTO products. As Apple pushes the boundaries of desktop computing, ATTO continues to provide industry leading products that op

Seaborn Networks' CEO Larry Schwartz is Named in List of 100 Most Powerful People in Telecoms Worldwide14.12.2017 16:12Pressemelding

BOSTON, Dec. 14, 2017 (GLOBE NEWSWIRE) -- Seaborn Networks ("Seaborn"), a leading developer-owner-operator of submarine fiber optic cable systems, is pleased to announce that Larry Schwartz, Seaborn's Chairman & CEO, has been named one of the 100 most powerful people in the telecoms industry by Global Telecoms Business ("GTB"). The Power 100 List annually identifies the most influential people in telecoms, content and Internet companies, selecting nominations from readers of the publication. Larry is one of only six people included on the list from the global subsea and data center industries. GTB notes that these top 100 were "those the industry felt were the real power, the real influencers, behind the telecoms sector" and were chosen by the editorial team with input from GTB's readers. In only a few years, Larry has led Seaborn from being a start-up to now being a leading player in the global telecommunications industry, setting precedents with its business model, fina

Mayo Clinic to begin Prospective Clinical Study with Medibio Technology for Expanded Market Opportunities14.12.2017 15:10Pressemelding

Study designed to determine differential diagnosis in depression patients Study designed to monitor patient data following pharmacological treatment SYDNEY, Australia and MINNEAPOLIS, Dec. 14, 2017 (GLOBE NEWSWIRE) -- Medibio Limited (MEB or the Company) (ASX:MEB) (OTCQB:MDBIF), a mental health technology company that has pioneered the use of objective biometrics to assist in the screening, diagnosing, monitoring and management of depression and other mental health conditions,  is pleased to announce the first prospective clinical trial with Mayo Clinic under a 5-year Master Clinical Trial Agreement that was signed in October of this year.  This initial study, undertakes the prospective diagnosis and longitudinal monitoring of both unipolar and bipolar depression, along with the depressive subtypes (melancholic and atypical). The primary goal is to characterize longitudinal autonomic, circadian, and

The 1st free cross-border ecommerce library available to online merchants14.12.2017 10:00Pressemelding

A competitive edge instrumental in succeeding in today's dynamic retail world AMSTERDAM, The Netherlands, Dec. 14, 2017 (GLOBE NEWSWIRE) -- Acapture, a global, data-driven omnichannel PSP, has released a complete library of free infographics for merchants, outlining the latest exclusive data for 31 of the world's most exciting ecommerce markets. Online retailers, marketplaces, and other ecommerce merchants are given a competitive edge, instrumental in succeeding in today's dynamic retail world. With each infographic providing actionable stats, facts and figures from a major ecommerce region, illustrated with clear, reader-friendly graphics, the collection is essential reading for all merchants looking to seize current cross-border opportunities. By understanding the preferred local payment methods, the most popular B2B and B2C product categories, top import and export regions, most popular ecommerce sites and much more, merchants can make

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

Besøk vårt presserom