Minerva Announces Outcome of End-of-Phase 2 Meeting With FDA
Pivotal Phase 3 trial design to include monotherapy administration of MIN-101 and primary endpoint of improvement in negative symptoms of schizophrenia
Planned initiation of MIN-101 Phase 3 development in second half of 2017
WALTHAM, Mass., May 15, 2017 (GLOBE NEWSWIRE) -- Following a recent "end-of-Phase 2" meeting with the U.S. Food and Drug Administration (FDA), 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 its plans to initiate Phase 3 development of MIN-101, a drug targeting negative symptoms in schizophrenia patients. A pivotal Phase 3 trial with MIN-101 is expected to be initiated in the second half of 2017.
The Phase 3 trial design will be a 12-week, double-blind, randomized, placebo-controlled, monotherapy study testing two doses of MIN-101 in patients with negative symptoms and a diagnosis of schizophrenia. To be eligible for this study, patients will be required to have stable negative and positive symptoms over several months prior to enrollment, with a specified minimum threshold baseline score on the Positive and Negative Syndrome Scale (PANSS) negative sub-scale.
After the double-blind phase, patients may enter a 36-week open label extension phase in which all patients will receive active treatment. This multi-center, international trial is expected to enroll approximately 500 patients at approximately 60 clinical sites across the U.S. and Europe.
The primary endpoint will be improvement in negative symptoms at 12 weeks as measured by the PANSS Marder negative factor score, a widely recognized instrument for quantifying severity of negative symptoms. Secondary efficacy endpoints will include the Clinical Global Impression of Severity (CGI-S) scale and Personal and Social Performance (PSP) total score. The overall design of the planned Phase 3 trial is similar to the Phase 2b trial completed in 2016, in which improvement was observed in schizophrenic patients with negative symptoms treated with MIN-101 compared to placebo.
The Company shared pre-clinical and clinical efficacy and safety data at the FDA meeting, and safety and tolerability of MIN-101 will continue to be assessed during the duration of the Phase 3 trial, including cardiac function via electrocardiograms (ECGs). Discontinuation criteria based on PANSS and cardiac electrophysiological criteria will be incorporated into the study protocol.
"Minerva is finalizing its plan for the Phase 3 development of MIN-101, an innovative investigational treatment for schizophrenia, following our recent meeting with the FDA," said Dr. Remy Luthringer, president and chief executive officer of Minerva. "Our discussion with the agency has helped to confirm our Phase 3 trial design, which is similar to our previous Phase 2b trial design. We believe that positive data from the Phase 3 trial, along with the positive data from the Phase 2b trial, may form the basis for the future submission of a New Drug Application for MIN-101 to the FDA."
"The constructive feedback from the agency supports the further development of MIN-101 for schizophrenia," said Dr. Philip D. Harvey, Leonard M. Miller Professor of Psychiatry and director of the Division of Psychology at the University of Miami Miller School of Medicine. "Negative symptoms currently continue to represent a significant unmet need and contribute substantially to poor quality of life and functional outcomes for the large worldwide population of patients with this disease."
Updates and further details regarding the Phase 3 trial, including anticipated timing of recruitment, participating centers and investigators will be provided later this year and posted on www.clinicaltrials.gov.
About schizophrenia and the impact of negative symptoms
Schizophrenia remains among the top ten disabling conditions worldwide for young adults and affects more than 21 million people worldwide. According to Datamonitor, an independent market research firm, in 2016 approximately 3.3 million people suffered from schizophrenia in the United States, Japan and the five major European Union markets of France, Germany, Italy, Spain and the United Kingdom.
Although positive psychotic symptoms are characteristic of schizophrenia, negative symptoms constitute one of the main sources of burden of illness, represent an important treatment target and are a major cause of the poor vocational and social capabilities of these patients. These symptoms, which include a-motivation, avolition, lack of initiative, and restricted personal interaction, are associated with poor psychosocial functioning.
In the majority of schizophrenia patients, acute positive symptoms remit due to treatment with antipsychotics (dopamine-blocking drugs) or spontaneously. Antipsychotic drugs also reduce the risk for recurrence of psychosis. However, many patients maintain remission of psychosis without antipsychotic dopamine blocking drugs. Nevertheless, they continue to suffer negative symptoms, for which no FDA-approved treatments are specifically indicated.
MIN-101 is a drug candidate with equipotent affinities for sigma 2 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.
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 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
Standard Lithium Announces Closing of $21.6 million Bought Deal Private Placement of Units16.2.2018 19:25 | Pressmeddelande
THIS NEWS RELEASE IS INTENDED FOR DISTRIBUTION IN CANADA ONLY AND IS NOT INTENDED FOR DISTRIBUTION TO UNITED STATES NEWSWIRE SERVICES OR DISSEMINATION IN THE UNITED STATES. VANCOUVER, British Columbia, Feb. 16, 2018 (GLOBE NEWSWIRE) -- Standard Lithium Ltd. ("Standard Lithium" or the "Company") (TSX-V:SLL) (OTCQX:STLHF) (FRA:S5L) announced today that it has closed its previously announced bought deal private placement of 10,312,821 units of the Company (the "Units"), at a price of $2.10 per Unit, for aggregate gross proceeds to the Company of $21,656,924, including the issuance and sale of the Underwriters' (as defined below) option (the "Offering"). Each Unit consists of one common share of the Company and one-half of one common share purchase warrant (each whole common share purchase warrant, a "Warrant"). Each Warrant is exercisable to acquire one common share of the Company (a "Warrant Share") until February 16, 2020 at an exercise price of $2.60 per Warrant Share, subject to adjus
Cisco Offers Cloud-Based Endpoint Security Solutions for Managed Security Service Providers16.2.2018 14:00 | Pressmeddelande
Cisco's comprehensive cloud-based security endpoint portfolio provides advanced malware protection, internet security, and enterprise mobility management SAN JOSE, Calif., Feb. 16, 2018 (GLOBE NEWSWIRE) -- Cisco today is helping address the challenges of Managed Security Service Providers (MSSP) and their customers by offering MSSPs comprehensive security, visibility, and control of customer endpoints without added hardware or complexity. The Cisco endpoint security portfolio includes three industry-leading solutions-Cisco AMP for Endpoints, Cisco Umbrella, and Meraki Systems Manager to offer protection against advanced malware and threats. Security teams know the endpoints in their environments are being targeted by advanced threats, but often lack the security talent, tools, and budget to address those challenges. As a result, organizations of all sizes are choosing to augment their in-house IT security with managed security services. Nearly half of SMBs and enterprises in the US1 ar
Aurora Solar Adds Heterojunction Cell Characterization to Decima Gemini Family16.2.2018 14:00 | Pressmeddelande
Aurora Solar Technologies Inc. / Aurora Solar Adds Heterojunction Cell Characterization to Decima Gemini Family . Processed and transmitted by Nasdaq Corporate Solutions. The issuer is solely responsible for the content of this announcement. NORTH VANCOUVER, British Columbia, Feb. 16, 2018 (GLOBE NEWSWIRE) -- Aurora Solar Technologies Inc. ("Aurora") ("Company") (TSX.V:ACU) (OTCBB:AACTF) (FSE:A82) is pleased to provide an update on the further development of its Decima Gemini(TM) infrared measurement technology for applications in the rapidly developing heterojunction (HJT) cell manufacturing market. HJT is an ultra high-efficiency solar cell design pioneered by Japan's Panasonic Corp., who is now also partnered with Tesla Inc. for solar products. According to Solar Media Ltd., HJT production capacity is expected to increase by 20 percent this year. To produce the electrical structure of a HJT cell, it is necessary to apply thin layers of amorphous silicon on both sides of a crystallin
Nasdaq Cited as a Leader in Governance, Risk, and Compliance Platforms by Independent Research Firm16.2.2018 13:35 | Pressmeddelande
NEW YORK, Feb. 16, 2018 (GLOBE NEWSWIRE) -- Nasdaq (Nasdaq:NDAQ) was among the select companies that Forrester invited to participate in its 2018 Forrester Wave(TM) evaluation, Governance, Risk, And Compliance (GRC) Platforms, Q1 2018. In this evaluation, Nasdaq was cited as a Leader in Governance, Risk, and Compliance Platforms and received the maximum score of 5 for the evaluation criteria "Risk & Control Management", "Audit Management", "Dashboard and Reporting" and "Integration capabilities" for its BWise solutions. "We feel the strong scores we obtained in important functional areas provide assurance to our clients that they have selected a robust and future-proof software platform," said Tom Passon, Head of Product Innovation & Global Standards, Nasdaq BWise. "We are proud of this recognition that encourages us to further execute on our strategy to provide user-friendly, pre-configured best practice solutions that combine our innovative GRC software platform with leading expertis
Mandalay Resources Provides Target Release Date for Fourth Quarter and Full-Year 2017 Financial Results and Conference Call16.2.2018 13:30 | Pressmeddelande
TORONTO, Feb. 16, 2018 (GLOBE NEWSWIRE) -- Mandalay Resources Corporation ("Mandalay" or "the Company") (TSX:MND) today announced that its fourth quarter and full-year 2017 financial results will be released after market close on February 21, 2018, followed by a conference call with Mark Sander, President and Chief Executive Officer of Mandalay, for investors and analysts on February 22, 2018 at 8:00 am (Toronto time). Analysts and interested investors are invited to participate using the following dial-in numbers: Participant Number: (201) 689-8341 Participant Number (Toll free): (877) 407-8289 Conference ID: 13676606 A replay of the conference call will be available until 11:59 pm (Toronto time), March 8, 2018 and can be accessed using the following dial-in number: Encore Toll Free Dial-in Number: (877) 660-6853 Encore ID: 13676606 For Further Information: Mark Sander President and Chief Executive Officer Greg DiTomaso Director of Investor Relations Contact: +1.647.260.1566 About Man
Apricus Biosciences Receives Complete Response Letter from FDA for Vitaros(TM)16.2.2018 13:00 | Pressmeddelande
Company Evaluating Deficiencies and Potential Path Forward SAN DIEGO, Feb. 16, 2018 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in urology and rheumatology, today announced that the U.S. Food and Drug Administration ("FDA") has issued a complete response letter ("CRL") for the New Drug Application ("NDA") of Vitaros(TM) (alprostadil, DDAIP.HCl), a topical cream for the treatment of erectile dysfunction. The CRL indicates that the FDA cannot approve the NDA for Vitaros in its present form, identifying deficiencies related to Chemistry, Manufacturing and Control ("CMC") and certain safety concerns specific to the 2.5% concentration of DDAIP.HCl contained in the current formulation. "We are disappointed with the outcome of the review given the substantial amount of CMC, clinical and non-clinical data and analysis provided to the FDA in the Vitaros resubmission. We are assessing the content of the complete response
I vårt pressrum kan du läsa de senaste pressmeddelandena, få tillgång till pressmaterial och hitta kontaktinformation.Besök vårt pressrum