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
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.
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/
Minerva Neurosciences, Inc.
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
Följ NASDAQ OMX
Abonnera på våra pressmeddelanden.
Senaste pressmeddelandena från NASDAQ OMX
CrownBio Supports Excellence in Translational Research with Grant Award that Funds Innovative PDX Model Development in Immuno-Oncology19.7.2018 15:03 | Pressmeddelande
"Cancer Research Center of Lyon iPS novel PDX models formulate new immune cell focused strategies" SAN DIEGO, July 19, 2018 (GLOBE NEWSWIRE) -- Crown Bioscience, a global drug discovery and development services company providing translational platforms to advance oncology, inflammation, cardiovascular and metabolic disease research, is proud to announce the award of its Patient-Derived Xenograft (PDX) grant program to doctors Fabrice Lavial, Christophe Caux and Bertrand Dubois from the Cancer Research Center of Lyon (CRCL). The grant program was established to support oncology researchers pursuing scientific advancements in cancer using PDX technology. Following an extensive review, CrownBio's Scientific Steering Committee selected Dr. Lavial and his colleagues at the CRCL due to their project's potential to create breakthroughs in preclinical oncology strategies. Their research combines PDX and iPS cell technologies to create patient-specific, humanized models. These unique models wil
Jumio Introduces Liveness Detection for Web to Better Deter Fraud During Account Onboarding19.7.2018 14:00 | Pressmeddelande
New identity proofing functionality ensures that the person behind a Web upload verification is present and the person actually creating a new online account PALO ALTO, Calif., July 19, 2018 (GLOBE NEWSWIRE) -- Jumio, the creator of Netverify(TM) Trusted Identity as a Service (TIaaS), today announced the addition of Liveness Detection for Web to better thwart fraudsters' evolving and sophisticated attempts to assume another individual's identity. With identity verification, Jumio's approach is to first verify the government-issued ID (e.g., driver's license, passport or ID card) and ensure that it is authentic and has not been doctored. For mobile SDK customers, Jumio then requires the user to take a selfie which enables the company to compare the person in the selfie to the person pictured in the ID document. Since Netverify is an omnichannel solution, Jumio also supports identity verification via desktop webcams. This channel enables our customers to reach large market segments who a
Northland Power Adds 17MW of Capacity to the Deutsche Bucht Offshore Wind Farm19.7.2018 12:33 | Pressmeddelande
TORONTO, July 19, 2018 (GLOBE NEWSWIRE) -- Northland Power Inc. ("Northland") (TSX:NPI) announced today that the Deutsche Bucht Mono Bucket pilot demonstrator ("Demo") project has reached financial close. All required funds for the Demo project have been contributed by Northland and committed by the project lenders. In May, the Federal Maritime and Hydrographic Agency of Germany (BSH) granted the Deutsche Bucht offshore wind project the permit required to erect two additional pilot wind turbines using Mono Bucket foundations. Deutsche Bucht will be the first offshore wind farm worldwide to test this new type of foundation structure under commercial operating conditions. As previously announced, the two turbines will contribute an additional 17 MW of capacity to the base 252 MW project for a total of 269 MW and bringing the total project cost to approximately €1.4 billion (CAD $2.0 billion) - up from €1.3 billion. Northland's corporate investment has increased from approximately $400 mi
Canadian Natural Resources Limited Announces 1 Billion Barrel Production Milestone at the Athabasca Oil Sands Project19.7.2018 11:00 | Pressmeddelande
CALGARY, Alberta, July 19, 2018 (GLOBE NEWSWIRE) -- Canadian Natural Resources Limited ("Canadian Natural"), as operator of the Jackpine and Muskeg River mines at the Athabasca Oil Sands Project ("AOSP"), is pleased to announce that the AOSP has achieved a mined production milestone of 1 billion barrels since operations began in 2003. Canadian Natural's President Tim McKay stated, "This is a significant milestone and demonstrates the size and scale of Canada's oil sands mining operations. The oil sands, through responsible development, provide sustainable long life low decline production and significant value for stakeholders. This milestone could not have been achieved without the dedication of the employees and contractors who focus on safe, reliable operations, while minimizing our environmental footprint to ensure long term sustainable development." Canadian Natural has a 70% working interest in the AOSP along with Chevron Canada Limited (20%) and Shell Canada Limited (10%). Canadi
ForgeRock Opens Up Open Banking19.7.2018 10:00 | Pressmeddelande
Delivers New, Open Reference Implementation and Sandbox Directory for Developers to Test Open Banking APIs in Five Minutes or Less LONDON, July 19, 2018 (GLOBE NEWSWIRE) -- ForgeRock®, the leading platform provider of digital identity management solutions, announced today the availability of the ForgeRock Open Banking Directory. Continuing its commitment to innovation and industry leadership, ForgeRock has delivered a reference bank implementation and directory, providing a technical sandbox for organizations looking to build and test Open Banking/PSD2 APIs. The lightweight and incredibly fast test platform has been acknowledged and celebrated by the team at UK Open Banking, the Implementation Entity set up by the UK Government's Competition and Markets Authority (CMA) in 2016, to deliver Open Banking. The ForgeRock development team has created an Open Banking Technical Solution Guide on the directory. Open Banking regulations, which began coming online in the UK earlier this year, for
TradeStation International Ltd to Offer Subscription Account Featuring TradeStation Technologies' Advanced Analytical Capabilities19.7.2018 10:00 | Pressmeddelande
LONDON, July 19, 2018 (GLOBE NEWSWIRE) -- TradeStation International Ltd, the London-based, United Kingdom subsidiary of TradeStation Group, Inc., today announced that it is now offering European traders, investors, advisors and market analysts access to TradeStation Analytics -- a non-brokerage subscription account featuring all of the advanced analytical capabilities of the TradeStation award-winning* platform. The software subscription account, which is provided to customers directly by affiliate TradeStation Technologies, Inc., offers market participants an opportunity to join the thousands of U.S.-based TradeStation subscribers - professionals and non-professionals alike - who trust TradeStation's cutting-edge technology to perform sophisticated market analysis, identify opportunities and stay one step ahead of today's rapidly changing financial markets. This TradeStation Analytics premium subscription package includes: Market Data delivered with speed, accuracy and reliability, w
I vårt pressrum kan du läsa de senaste pressmeddelandena, få tillgång till pressmaterial och hitta kontaktinformation.Besök vårt pressrum