Minerva Neurosciences Announces Positive Data From Six-Month Extension of Phase IIb Trial of MIN-101 Monotherapy in Schizophrenia
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.
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.
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.
2 Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, American Psychiatric Association.
William B. Boni
VP, Investor Relations/
Minerva Neurosciences, Inc.
Om NASDAQ OMX
NASDAQ OMX (NASDAQ: NDAQ) is a leading provider of trading, exchange technology, information and public company services across six continents.
Følg saker fra NASDAQ OMX
Registrer deg med din epostadresse under for å få de nyeste sakene fra NASDAQ OMX på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra NASDAQ OMX
Nasdaq Welcomes RISE Education Cayman Ltd. (Nasdaq: REDU) to The Nasdaq Stock Market20.10.2017 18:37 | Pressemelding
NEW YORK, Oct. 20, 2017 (GLOBE NEWSWIRE) -- RISE Education Cayman Ltd. (Nasdaq:REDU), a leader in China's junior English Language Training (ELT) market, rang the opening bell at the Nasdaq MarketSite in Times Square today in celebration of its initial public offering (IPO) on The Nasdaq Stock Market. Photos accompanying this announcement are available at http://www.globenewswire.com/NewsRoom/AttachmentNg/f59490cf-9a81-4114-92a1-05edcb3f5694 http://www.globenewswire.com/NewsRoom/AttachmentNg/5692f99d-9ed0-4be2-928d-9c94f4b152e8 RISE pioneered the "subject-based learning" teaching philosophy in China, whereby various subject matters, such as language arts, math, natural science and social science are used to teach English. RISE's course offerings use interactive courseware to create an immersive English learning environment that helps students learn to speak and think like a native speaker. In addition, their curricula are des
Concurrent Achieves Sales Milestone for Zephyr Transcode19.10.2017 15:35 | Pressemelding
Concurrent Customers Now Transcoding on Three Continents ATLANTA, Oct. 19, 2017 (GLOBE NEWSWIRE) -- Concurrent (NASDAQ:CCUR), a global leader in storage, protection, transformation, and delivery of visual media assets, announced today that Zephyr Transcode, which Concurrent launched last year as an integral part of its content delivery network (CDN) solutions, is now deployed with customers in Asia, Europe and North America. The deployments already support thousands of on-demand assets being transcoded to multiple formats and bit-rates to support any place, any device content availability. Zephyr Transcode supports multiple formats and quality levels including H.264 (MPEG-4) and H.265 (HEVC), strengthening Concurrent customers' capability to provide high-quality standards-based streams to any device their end-users desire. Zephyr Transcode is software-based and capable of running in traditional Central Processing Units (CPU) as well as Gra
German Armed Forces Renews Contract for Hexagon Geospatial Products19.10.2017 15:11 | Pressemelding
Defense agency will work closely with Hexagon Geospatial Premium Partner for next two years NORCROSS, Ga., Oct. 19, 2017 (GLOBE NEWSWIRE) -- At the HxGN LOCAL Defense Summit, a conference dedicated to defense and security in Western Europe, Hexagon Geospatial announced that the Bundeswehr Geoinformation Centre (BGIC) recently renewed a large software maintenance contract for Hexagon Geospatial products. The two-year renewal is for more than 100 licenses, mainly within the GeoMedia and ImageStation product families. The contract also includes consulting for workflow optimization. The contract was issued to Geosystems, a Hexagon Geospatial Premium Partner, which will work closely with the local subsidiary of Hexagon Safety & Infrastructure in Bonn and Munich to support BGIC. "The strong Hexagon Geospatial partner network allows our defense customers to benefit from a unique pool of expertise and tradecraft in the areas of remote sensing, GIS, and photog
Novel Preclinical Research Tools Provide Humanized Immune Response to Advance Immunotherapeutic Development, Live Webinar Hosted by Crown Bioscience19.10.2017 14:00 | Pressemelding
SANTA CLARA, Calif., Oct. 19, 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 a live webinar to be presented by Dr. Michelle Mack, Director of Global Scientific Engagement, entitled "Beyond Syngeneics - Novel Tools for Addressing Human Specificity in Immuno-Oncology." Checkpoint inhibitors like anti-PD-1, anti-PD-L1, and anti-CTLA-4 have revolutionized cancer treatment and have recently gained approval in several cancer types. Despite their potential, immunotherapies face significant development challenges due to the specificity and complexity of the human immune system upon which they act. Crown Bioscience has generated innovative research models to address these obstacles early during preclinical drug development.
Perfectus Aluminum Inc. Responds to Trade Group19.10.2017 13:00 | Pressemelding
ONTARIO, Calif., Oct. 19, 2017 (GLOBE NEWSWIRE) -- Perfectus Aluminum Inc. has issued the following: On October 12, 2017 the Aluminum Extruders Council (AEC), an industry group representing largely American aluminum extruders, posted to its blog a false narrative regarding a suit to which Perfectus Aluminum Inc. is a related party. The government is not "seeking unpaid duties from Perfectus for goods brought into the country." Rather, the government is attempting to use a 2017 Department of Commerce determination to assess retroactive antidumping duties on goods imported as early as 2011. It is discouraging that AEC would tout such an obviously egregious government overstep as a "victory" to their members and the industry: were it one of AEC's own members facing such an obvious violation of fair play and due process, it would rightfully argue that government overreach is a threat to manufacturers everywhere. In addition to the hypocrisy of the AEC's promotion of this case, its s
Payvision's annual report reveals cross-border ecommerce trends in 201719.10.2017 09:00 | Pressemelding
With online marketplaces and consumer technology leading the way for growth AMSTERDAM, The Netherlands, Oct. 19, 2017 (GLOBE NEWSWIRE) -- Payvision, global acquirer and data-driven omnichannel solutions provider, has published the findings of its fifth annual cross-border ecommerce research report, in collaboration with Juniper Research. The paper includes the results of a global survey of various industry players regarding the game-changers, the biggest challenges, the best practices for going cross-border, and much more. When compared to last year's findings, the report reveals a new and exciting context for global cross-border trade. The compound annual growth rate predicted for the next three years for cross-border ecommerce is now 17%, whereas it stands at just 12% for ecommerce overall. Also, over the past 12 months, merchants' attitudes towards cross-border ecommerce have become more positive, with 50% of respondents agreeing and 31% strongly
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom