Minerva Announces Outcome of End-of-Phase 2 Meeting With FDA
15.5.2017 14:00 | NASDAQ OMX
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
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
Brand Industrial Services Announces Agreement to Acquire Venko Groep BV16.8.2017 19:40 | Pressemelding
Complementary core strengths provide broader range of services for customers KENNESAW, GA, Aug. 16, 2017 (GLOBE NEWSWIRE) -- Brand Industrial Services, known as BrandSafway, has signed an agreement to acquire Venko Groep BV, a portfolio company of Mentha Capital. Venko will become a part of the Brand Energy & Infrastructure Services (Brand) group. "We are very pleased to announce the agreement with Venko," said Bill Hayes, President and CEO of BrandSafway. "Our combined customers in Europe will benefit from a broader range of solutions and greater depth of expertise in access, insulation and coatings. Bringing Venko's highly specialized knowledge in coatings to BrandSafway will provide the expertise we need to expand our services in the offshore market worldwide." Based in the Netherlands, with a focus on operations in the North Sea area, Venko is a leading offshore and onshore coatings maintenance provid
Abeona Therapeutics Announces Pivotal Expansion of ABO-102 Gene Therapy Clinical Trials in Sanfilippo Syndrome Type A16.8.2017 15:38 | Pressemelding
NEW YORK and CLEVELAND, Aug. 16, 2017 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq:ABEO), a leading clinical-stage biopharmaceutical company focused on developing novel gene therapies for life-threatening rare diseases, today announced the pivotal expansion of its gene therapy clinical trials for patients with MPS IIIA in the USA, Europe and Australia. "We have completed the necessary regulatory and ethical committee approvals and site initiations in Europe and Australia in order to accelerate enrollment," stated Juan Ruiz, M.D., Ph.D., Abeona's Chief Medical Officer. "We remain very encouraged by the improvements observed in clinically relevant biomarkers post-dosing of ABO-102, including durable reductions in heparan sulfate measured in the CNS, reduction of organ disease pathology, and signals of CNS improvement or stabilization at one-year follow-up in Cohort 1 subjects, and look forward to providing a more fulsome clinical update at important clinical
CallidusCloud Wins Eight Gold Stevies® in the 2017 International Business Awards16.8.2017 14:00 | Pressemelding
CallidusCloud Lead to Money suite recognized as Best B2B New Product of the Year. LeadRocket voted Best New Product or Service of the Year in the Software - Lead Generation Solution category. DUBLIN, Calif., Aug. 16, 2017 (GLOBE NEWSWIRE) -- Callidus Software Inc. (NASDAQ:CALD), a global leader in cloud-based sales, marketing, learning, and customer experience solutions, announced today that it was named the winner of eight Gold Stevie® awards in the 2017 International Business Awards. "The eight Stevie® awards earned highlight CallidusCloud's momentum, commitment to excellence, passion for innovation and customer orientation," said Leslie Stretch, president and CEO of CallidusCloud. "They also recognize the benefits that the Lead to Money suite, honored as the Best New Product in Business-to-Business, accrues to its customers in terms of enabling faster, bigger, and more profitable sales." CallidusCloud's Go
Ascom Myco and Koutio Médipôle optimize care communications and responsiveness16.8.2017 08:00 | Pressemelding
Ascom Holding AG / Ascom Myco and Koutio Médipôle optimize care communications and responsiveness . Processed and transmitted by Nasdaq Corporate Solutions. The issuer is solely responsible for the content of this announcement. Enabled by the Ascom Myco smart device, the new Koutio Médipôle is realizing improved care delivery through seamless information flow from the point of care to anywhere. BAAR, Switzerland, Aug. 16, 2017 (GLOBE NEWSWIRE) -- The new Koutio Médipôle hospital in the New Caledonian capital Nouméa, located in the southwest Pacific Ocean, has optimized patient care communications and responsiveness for the new 645-bed facility by deploying Ascom Myco Wi-Fi devices to support clinician teams and Ascom Myco Wi-Fi/GSM handsets, used across paramedic teams. The Ascom solution is seamlessly aligned with clinical workflow and applications (nurs
VistaJet Harnesses the Power of the American Eclipse to Offer Customers a Rare Viewing Opportunity15.8.2017 18:40 | Pressemelding
VistaJet invites customers to fly in parallel with an astronomical anomaly NEW YORK, Aug. 15, 2017 (GLOBE NEWSWIRE) -- VistaJet, the first and only global aviation company, will be offering customers the opportunity to experience and chase the American Solar Eclipse, appearing for the first time in 99 years on August 21, 2017. A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/c0c41d7d-7ad9-4a46-9d2d-dcc1148b4772 The coast-to-coast National Eclipse and astronomical phenomenon will be visible in the United States from approximately 10:15AM PST, with the sun disappearing behind the moon from the Oregon coast, passing through 14 states to South Carolina. Without being in this 70-mile strip, Americans will not be able to see the sun eclipsed in totality. With unparalleled experience flying into and out of the hardest to reach destinations, VistaJet is offer
NGX Bio Raises $3 Million to Fund Growth of Its DNA Sequencing Marketplace15.8.2017 17:00 | Pressemelding
SAN FRANCISCO, Aug. 15, 2017 (GLOBE NEWSWIRE) -- NGX Bio, Inc., (www.NGXbio.com) the premier marketplace for online DNA sequencing services, announced it has closed a $3 million funding round. The round was led by 180 Degree Capital Corp. (NASDAQ:TURN) and included Third Kind Venture Capital, Lateral Capital, the Band of Angels and the Berkeley Angel Network, as well as other investors. NGX Bio was founded in 2014 to provide streamlined, on-line access to next-generation sequencing services for clients seeking high quality, rapid and cost-effective sequencing of both human and non-human samples globally. Demand for sequencing services is growing exponentially. NGX Bio's platform matches the sequencing needs of customers with providers who have available sequencing capacity. Customers are able to purchase a wide range of sequencing services for their samples using NGX Bio's online ordering tools. NGX Bio offers these services through numerous and deep relationships with its
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom