Minerva Neurosciences Announces Positive Top Line Results From Phase Ib Clinical Trial in Major Depressive Disorder With MIN-202
Treatment with selective orexin-2 receptor antagonist observed to be well tolerated and to improve symptoms of depression, independent from its effect on sleep
WALTHAM, Mass., March 11, 2016 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ:NERV), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system (CNS) disorders, today announced positive top line results from a Phase Ib clinical trial in major depressive disorder (MDD) with MIN-202 (JNJ-42847922), a selective orexin-2 receptor antagonist under joint development with Janssen Pharmaceutica NV.
“Treatment with MIN-202 was observed to result in consistent improvements in the symptoms of depression in MDD patients in this trial,” said Dr. Remy Luthringer, president and chief executive officer of Minerva. “The results pave the way to initiate a Phase IIb trial in patients suffering from MDD. These improvements support the potential of MIN-202 to have a direct effect on mood independent from its effect on sleep. We previously observed that MIN-202 had a significant effect on sleep in our Phase IIa trial in patients suffering from insomnia disorder.”
The Phase 1b trial was a randomized, multi-center, double-blind, parallel group, diphenhydramine- and placebo-controlled study to evaluate the effect of MIN-202 in MDD outpatients 18-65 years of age. Forty-eight participants were enrolled in three groups that received doses of 20 milligrams (mg) of MIN-202 daily, 25 mg of diphenhydramine daily (used as a positive control to induce sedation) or placebo over four weeks.
MIN-202 was observed to be well tolerated by study participants over a one-month treatment duration, with no new emerging safety signals and no serious adverse events.
Consistently greater improvements in depressive symptomatology were observed in patients randomized to receive MIN-202 compared to those randomized to receive placebo (PLA) or diphenhydramine (DPH), as measured by clinician administered rating scales, including the Hamilton Depression Rating Scale (HDRS17). Core symptoms of depression (as measured by the HAM-D6) were observed to be significantly improved in the MIN-202 arm when compared with the PLA arm.
The primary endpoint was safety and tolerability, and secondary endpoints included assessments of depressive symptomatology, cognition and sleep. The trial was conducted at seven clinical sites in Europe. Only top line results with respect to safety, tolerability and efficacy on depressive symptomatology are reported in this press release. Complete results are planned for peer-reviewed presentation in the future.
MIN-202 is also under development to treat primary insomnia disorder. Recently announced top line data from a Phase IIa trial in this indication included statistically significant improvements in sleep efficiency (SE) as measured by objective polysomnography, the primary endpoint of the trial, observed in study patients treated with MIN-202, with an acceptable safety and tolerability profile, compared to patients treated with placebo.
Minerva entered into a co-development and license agreement with Janssen in February 2014 covering MIN-202 and other orexin-2 compounds. Under this agreement, Minerva has an exclusive license to these compounds in the European Union, Switzerland, Liechtenstein, Iceland and Norway. Janssen has exclusive rights to these compounds worldwide outside of these territories.
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 Phase IIb development for schizophrenia; MIN-202 (JNJ-42847922), in Phase IIa and Phase Ib development for insomnia and adjunctive treatment of MDD, respectively; MIN-117, in Phase IIa 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 regarding MIN-202; the timing of future clinical trials and results of clinical trials regarding MIN-202; the clinical and therapeutic potential of MIN-202; our ability to successfully develop and commercialize MIN-202; 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 only predictions and may differ materially from actual results due to a variety of factors including, without limitation, whether final data from the Phase Ib MIN-202 trial will be consistent with the preliminary results, whether MIN-202 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 MIN-202 will be successfully marketed if approved; whether our therapeutic product discovery and development efforts will be successful for MIN-202; 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 September 30, 2015, filed with the Securities and Exchange Commission on November 5, 2015. 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.
William B. Boni VP, Investor Relations/ Corp. Communications Minerva Neurosciences, Inc. (617) 600-7376
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
Brookfield Asset Management Notice of 2017 Q3 Results Conference Call and Webcast23.10.2017 17:03 | Pressemelding
Date: Thursday, November 9, 2017 Time: 11:00 a.m. (Eastern Time) BROOKFIELD, News, Oct. 23, 2017 (GLOBE NEWSWIRE) -- You are invited to participate in Brookfield Asset Management's 2017 Third Quarter Conference Call & Webcast on Thursday, November 9, 2017 at 11:00 a.m. (Eastern Time) to discuss with members of senior management our results and current business initiatives. These results will be released on November 9th before 7:00 a.m. (Eastern Time) and will be available following the release on our website at www.brookfield.com "News - Press Releases." The Conference Call will also be Webcast live on our website, where it will be archived for future reference. To participate in the Conference Call, please dial 1-800-319-4610 toll free in North America, or for overseas calls please dial 1-604-638-5340 at approximately 10:50 a.m. The Conference Call will also be Webcast live at http://servic
Rapid Micro Biosystems Awarded a Contract by Biomedical Advanced Research and Development Authority (BARDA) for the Implementation of a Rapid Sterility Test for Vaccines23.10.2017 13:00 | Pressemelding
LOWELL, Mass., Oct. 23, 2017 (GLOBE NEWSWIRE) -- Rapid Micro Biosystems, a leading provider of automated, non-destructive, rapid microbial detection, is pleased to announce the receipt of a $7.3 million contract from the Biomedical Advanced Research and Development Authority (BARDA) for the implementation of a rapid sterility test for vaccines. This awarded grant is part of BARDA's Advance Development of Medical Countermeasures for Pandemic Influenza, which focuses on improving the government's responsiveness to future pandemic threats. When combined with Rapid Micro Biosystems' automated Growth Direct(TM) detection system, the rapid sterility test will result in faster release of vaccines and other sterile products. Timely delivery of these products carries multiple public benefits, principally in facilitating rapid responses to pandemic or emerging infections, agents of bioterrorism, and availability of life saving medicines. "Our continuing relationship with BARDA demonstrate
Xehar Fashion App Ditches the Shopping Cart and Picks Up Speed23.10.2017 12:00 | Pressemelding
New fast fashion app will shorten the checkout time by removing the shopping cart altogether. PLAYA VISTA, Calif., Oct. 23, 2017 (GLOBE NEWSWIRE) -- Fashion tech company Xehar, today announces they will be removing the shopping cart from their Xehar shopping app. For millennial women shoppers who are interested in fashion but are frustrated with the online shopping experience, the Xehar app is their solution. "Xehar has found a way to increase conversion for app purchases by simply removing the function of the shopping cart," says Hadari Oshri, founder and CEO of Xehar. "Within the app, users select complete outfits and purchase with ease. By removing the shopping cart we are reducing friction and speeding up the checkout process." A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/c58ce496-70e7-4675-8f59-3e39725708c4 Website and app owners deal with the reality of shopping cart abandonment
BroadSoft Announces New Integrated and Intelligent Cloud Communication and Collaboration Experiences23.10.2017 07:30 | Pressemelding
Upgrades deliver on the BroadSoft Business cloud unified communication vision to deliver intuitive, consistent client experiences across the entire suite and reinvent workflow efficiencies PHOENIX, Oct. 23, 2017 (GLOBE NEWSWIRE) -- BroadSoft, Inc. (NASDAQ:BSFT) a global market share leader in cloud business software for unified communication as a service (UCaaS), and provider of collaboration and contact center as a service (CCaaS), today unveiled several enhancements to its BroadSoft Business portfolio at its annual user conference, BroadSoft Connections. Now leveraging a microservices architecture, BroadSoft Business offers updated app experiences and next-generation capabilities across the BroadSoft Business applications, UC-One, Team-One and CC-One. A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/0df82bc5-5481-4429-9586-bba075849626 Business users today are overwhelmed with managing their workfl
BroadSoft Business Cloud PBX, Team Collaboration and Contact Center Apps Now Available for Multinational Enterprises23.10.2017 07:30 | Pressemelding
New, localized data centers offer multinational enterprise customers secure, multi-language calling and collaboration between global offices via a single, borderless BroadCloud platform PHOENIX, Oct. 23, 2017 (GLOBE NEWSWIRE) -- BroadSoft, Inc. (NASDAQ:BSFT) a global market share leader in cloud business software for unified communication as a service (UCaaS), and provider of collaboration and contact center as a service (CCaaS), today announced its BroadSoft Business cloud communication suite is available worldwide via several new BroadCloud ® data centers throughout EMEA and APAC. This expansion allows multinational enterprises to rely on a single provider across their international locations to collaborate with peers and customers around the globe, while meeting full regulatory and security compliance across different countries. A recent McKinsey Global Institute 2016 report noted that cross-border bandwidth is projected to increase nine times over the next
Powered by BroadSoft Channel Program Introduces New Digital Customer Lifecycle Platform and Services to Enhance Revenue Growth23.10.2017 07:30 | Pressemelding
Powered by BroadSoft now includes more than 100 global channel partners to realize the full potential of the cloud unified communication and collaboration market opportunity PHOENIX, Oct. 23, 2017 (GLOBE NEWSWIRE) -- BroadSoft, Inc. (NASDAQ:BSFT) a global market share leader in cloud business software for unified communication as a service (UCaaS), and provider of collaboration and contact center as a service (CCaaS) today announced the addition of new digital customer lifecycle management tools including the BroadCloud® Channel Support System (CSS) and three new services: BroadSoft go-to-market services, BroadSoft onboarding services and BroadSoft adoption services. A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/b86c0264-fb6d-44fd-a7ae-38bba426e281 Powered by BroadSoft, which launched at BroadSoft Connections last year, currently supports 116 channel partners across the globe, v
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom