Nasdaq GlobeNewswire

Minerva Announces Completion of Bridging Study to Select Improved Formulation of MIN-101 for Use in Phase 3 Trial for the Treatment of Negative Symptoms in Patients With Schizophrenia

Del

New formulation observed to improve safety margin while offering bioequivalent exposure to prior formulation

Company to proceed with initiation of Phase 3 trial on schedule in second half of 2017

CMC scale-up work for NDA preparation initiated

WALTHAM, Mass., June 22, 2017 (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 the successful completion of a bridging trial to select an improved, gastric-resistant (GR) formulation of MIN-101. The Company plans to use the selected formulation in its upcoming Phase 3 clinical trial, which remains on schedule for initiation in the second half of 2017, as well as for the potential future submission of a New Drug Application (NDA). 

The key objective of the bridging study was to identify an improved formulation of MIN-101 that would:

  • Maintain similar exposure of MIN-101 based on area under the curve (AUC) as that shown in the Phase 2b study, which achieved its primary endpoint of improving negative symptoms in patients with schizophrenia with both doses tested, 64 milligrams (mg) and 32 mg; 
  • Reduce maximum concentration (Cmax) of an inactive metabolite of MIN-101 known as BFB-520, thereby reducing the potential for transient QTc increases observed in the Phase 2b study at the higher dose but not the lower dose;  
  • Eliminate food effect to allow the Phase 3 doses to be administered with or without food.

In summary, data from the bridging study of the selected new formulation demonstrated:

  • Bioequivalent exposures of MIN-101 as measured by AUC;
  • Reduction of Cmax of BFB-520 by approximately 30% compared to the formulation used in Phase 2b;
  • No observations of QTc prolongations throughout the study;
  • No observable food effect, thus allowing administration of the drug with or without food without changing its pharmacokinetic properties;
  • Confirmation of the overall safety and tolerability profile of MIN-101.

"The successful completion of this bridging study should allow us to initiate Phase 3 clinical testing with MIN-101 on schedule in the second half of 2017 with the same doses used in the Phase 2b trial, while potentially enhancing the safety profile of MIN-101," said Dr. Remy Luthringer, president and chief executive officer of Minerva. "The results from this study should also help to ensure the coherent interpretation of results from both the Phase 2b trial and the Phase 3 trial."

The Company plans to immediately initiate CMC scale-up processes that will form part of the NDA in the future. As exposures of MIN-101 in the Phase 2b study and the formulation to be used in the forthcoming Phase 3 are comparable, the Company believes data from both studies can be aggregated for the purposes of evaluating efficacy.  The Company has also filed a patent application for the GR formulation, which is in addition to an already granted patent in the U.S. that provides protection until 2035.  If granted, the additional patent could potentially extend exclusivity beyond 2035. 

The bridging study was an open-label, randomized, 3-treatment sequence, 3-period study to evaluate the plasma pharmacokinetic profile of MIN-101 and its metabolites (BFB-520 and BFB-999) after single oral administration of three formulations of MIN-101 (2 GR formulations and the formulation used in Phase 2b) under fasted condition to healthy volunteers.  Upon completion of the 3-period testing, the GR formulation that will be used in Phase 3 was then advanced and tested with food.

About MIN-101

MIN-101 is a drug candidate with equipotent affinities for sigma2 and 5-hydroxytryptamine-2A (5-HT2A) and lower affinity at Alpha1-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.

The Phase 2b trial with MIN-101, announced in 2016 and presented at the annual meeting of the American College of Neuropsychopharmacology, met its primary endpoint of statistically significant improvement in negative symptoms as measured by the PANSS pentagonal structure model and in the higher dose showed statistically significant benefit in multiple secondary endpoints that included general psychopathology. 

MIN-101 is designed to improve negative symptoms and cognitive impairment in schizophrenia, thereby increasing the patient's ability to function socially and vocationally while preventing the exacerbation of intermittent positive symptoms.

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-117, in clinical development for major depressive disorder (MDD); MIN-202 (JNJ-42847922), in clinical development for insomnia and 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 improved formulation of MIN-101 to be used in the planned Phase 3 trial of MIN-101; 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 potential for a single Phase 3 trial with supportive Phase 2b results to support the basis for an NDA; 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; 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 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.

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

GMAC Launches 'Study in China' Initiative in Partnership with 11 Leading Business Schools in China22.6.2018 06:01Pressemelding

BEIJING and HONG KONG, June 22, 2018 (GLOBE NEWSWIRE) -- On June 22, the Graduate Management Admission Council (GMAC) joins hands with 11 leading business schools in China to launch the "Study in China" initiative. This partnership marks the opening of an interactive platform for international students across 20 Belt and Road (B&R) regions to explore opportunities in China and to pursue higher education in business-related fields. The "Study in China" initiative aims to meet rapidly growing international student demand and to champion China as a world-class study destination and emerging global hub for business education. The "Study in China" online portal (www.studyinchinamba.com) officially launched today allows students to discover more about studying and living in China. The newly designed English-language website connects prospective students with partner business schools and offers access to an abundance of information to help find the perfect fit for their China education experi

Minimize the Impact of an Infrastructure Disaster with Integrated Asset Planning and Optimization21.6.2018 20:37Pressemelding

ATLANTA, June 21, 2018 (GLOBE NEWSWIRE) -- PowerPlan, a leader in asset investment optimization software, has released a new white paper titled, "Are you prepared to stop a large infrastructure disaster from also becoming a financial disaster?" The white paper highlights the impact of limited capital on infrastructure disaster relief, and offers solutions to minimize the impact with holistic asset plans. Sourcing the American Society of Civil Engineers, the paper states that the infrastructure in the United States has been rated a D+, showing no improvement from 2013. "All organizations hope that they can avoid asset failures from happening to their infrastructure. However, most don't have solutions in place that enable them to effectively plan their asset investment needs to prevent those failures," said Dillon Blakes, Senior Product Manager at PowerPlan. "With this paper, we hope to help educate asset intensive organizations, like those in the public sector, utilities, oil and gas, e

Shyft Unveils Board of Advisors Comprised of Top Crypto, Industry, and Regulatory Leaders United to Redefine Identity, Regulatory Compliance and Privacy For All21.6.2018 20:18Pressemelding

St. Michael, Barbados, June 21, 2018 (GLOBE NEWSWIRE) -- Shyft, a leading blockchain-based solution that is building a trusted ecosystem to enable secure and private data transfers, has announced its high profile Board of Advisors. Shyft's inaugural group of advisors bring deep industry knowledge from international business and finance, blockchain, economics, and Know Your Customer (KYC) and Anti Money Laundering (AML) compliance. The Board of Advisors will play a critical role in providing strategic guidance across multiple dimensions in Shyft's mission to make the global economy more efficient and effectively regulated. Shyft International Chairman Joseph Weinberg says: "At Shyft, we are ambitiously working to redefine the broken way our world uses and thinks about data, the same data that today defines our identity. Our group of advisors understand the dire need for a new system that allows attested data to not only be shared securely and privately, but also a system that can help b

United Shore Selects VITEC's EZ TV IPTV & Digital Signage Platform for New Headquarters21.6.2018 19:00Pressemelding

SUNNYVALE, Calif., June 21, 2018 (GLOBE NEWSWIRE) -- VITEC, a worldwide leader in advanced video encoding and streaming solutions, today announced that it has been chosen by United Shore to provide high-definition (HD), ultra-low-latency IP streaming and digital signage capabilities throughout the mortgage lender's new corporate headquarters in Pontiac, Michigan. Designed to seamlessly integrate with any IT environment and run on LAN, WAN, or wireless networks, the EZ TV Platform will provide United Shore with a secure, scalable, and cost-effective way to distribute a comprehensive lineup of TV channels and signage to more than 150 displays around the company's new 600,000-square-foot building over its IP infrastructure, and without the cost of installing RF cabling. Providing its more than 2,400 employees with valuable company information and essential television content, the new EZ TV Platform will be part of the company's initiative to create a dynamic and collaborative work environ

SEMAFO Announces Retirement of VP, Exploration & Mine Geology; Announces Geology Team Succession21.6.2018 17:24Pressemelding

MONTREAL, June 21, 2018 (GLOBE NEWSWIRE) -- SEMAFO Inc. (TSX:SMF) (OMX:SMF) announces the retirement of Mr. Michel Crevier as Vice-President, Exploration and Mine Geology and Qualified Person, effective June 30, 2018. Mr. Crevier will remain available to the Corporation on a consulting basis. As part of Mr. Crevier's succession plan, Richard Roy, who is currently exploration manager, will be promoted to Vice-President, Exploration. Furthermore, François Thibert, manager of the reserves and resources estimation group, will assume the role of Qualified Person in addition to managing mine geology activities. Retirement of Michel Crevier Michel Crevier joined SEMAFO in 2006 and has held the position of Vice-President, Exploration and Mine Geology and Qualified Person since 2010. With over 30 years of experience in exploration and mine geology, he successfully led the Corporation's exploration programs in Burkina Faso, Niger and Guinea. Benoit Desormeaux, President and CEO of SEMAFO, commen

MBA Hiring is Strong, with 4 in 5 Companies Planning to Hire Graduates in 201821.6.2018 15:00Pressemelding

MBA Graduates Commanding Salary Premiums RESTON, Va., June 21, 2018 (GLOBE NEWSWIRE) -- The Graduate Management Admission Council (GMAC) has released its 17th annual survey report, the GMAC 2018 Corporate Recruiters Survey report, and findings indicate that MBA hiring remains strong. Overall, 81 percent of responding companies plan to hire MBA graduates in 2018. Among all respondents globally, 52 percent of companies plan to increase MBA starting base salaries this year. Around the world , MBA graduates continue to command a salary premium relative to direct-from-industry hires and bachelor's degree hires. The projected median base starting salary for recent MBA graduates in the United States in 2018 is US$105,000, compared with US$85,000 for direct-from-industry new hires and US$65,000 for bachelor's degree new hires. The data reflect a slight decline in projected hiring among US and European employers compared to 2017's hiring plans: 85 percent of responding US companies and 64 perce

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

Besøk vårt presserom