NASDAQ OMX

Minerva Neurosciences Announces Positive Data From Six-Month Extension of Phase IIb Trial of MIN-101 Monotherapy in Schizophrenia

26.10.2016 14:30 | NASDAQ OMX

Del

WALTHAM, Mass., Oct. 26, 2016 (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 data from the 24-week open-label extension of its 12-week, randomized, double-blind, placebo-controlled Phase IIb clinical trial of MIN-101 as monotherapy in patients with negative symptoms of schizophrenia. Data from the 12-week core phase of this trial were reported in May of this year.

Graphic representations of the data summarized below are available at http://ir.minervaneurosciences.com/events.cfm and contained in the Current Report on Form 8-K filed by Minerva on October 26, 2016. 

“Data from the extension phase demonstrate a further and continuous improvement in negative symptoms in patients with schizophrenia, as measured by the negative symptom subscales of the Positive and Negative Syndrome Scale (PANSS),” said Dr. Remy Luthringer, president and chief executive officer of Minerva. “The longer patients were on monotherapy with MIN-101, the greater improvement they were observed to experience in their negative symptoms during the entire extension period, without evidence of reaching a plateau. We believe that such continuous improvement in symptoms over a nine month period in this patient population is unprecedented. 

“The data also provide an extended safety profile for MIN-101 consistent with that observed during the core double-blind phase of the trial,” said Dr. Luthringer.  “MIN-101 was reported to be well tolerated at both doses over the entire 36-week duration of the study by schizophrenic patients.  In addition, positive symptoms were observed to remain stable through the extension period as measured by the PANSS positive symptom subscale score. Improvements in overall schizophrenic psychopathology were also observed, as measured by the PANSS general psychopathology subscale and the total PANSS score.

“We believe these exciting data point the way toward pivotal testing of MIN-101 as a novel, differentiated treatment for the large worldwide population of patients with schizophrenia for whom negative symptoms contribute substantially to poor quality of life and functional outcomes,” said Dr. Luthringer.

Results announced earlier this year from the double-blind, placebo-controlled 12-week core phase of the trial showed that it met its primary endpoint of statistically significant improvement in negative symptoms as measured by the PANSS pentagonal structure model (PSM), and showed statistically significant benefit in multiple secondary endpoints that included general psychopathology and cognition. 

Patients who completed the core phase were provided the opportunity to enter into a 24-week, open-label extension phase.  During the extension phase, all patients received either 32 milligrams (mg) or 64 mg of MIN-101.  Patients who received placebo in the core phase were randomized to one of these two doses at the beginning of the extension phase.  Data generated during the extension period were intended to provide longer term supportive evidence of efficacy and to complement the statistically significant results obtained during the core phase.

One hundred forty-two patients from the treatment and placebo groups in the core phase entered the extension phase, with 88 patients completing the extension.   Seventy patients received 32 mg and 72 patients received 64 mg during the extension. 

Negative symptoms, assessed based on the PANSS PSM, were observed to continue to improve during the extension phase, as shown by a reduction from the study start for the 32 and 64 mg-treated groups of 5.5 points and 4.9 points, respectively, and by a reduction of 5.4 points and 5.3 points, respectively, in the PANSS three factors negative symptoms subscale.  Reductions over time of PANSS negative PSM scores are shown in the attached graph.

http://www.globenewswire.com/NewsRoom/AttachmentNg/a29ffbc7-ffb5-4dd6-af4e-f042defb88d5

Positive symptoms were observed to remain stable throughout the study, as measured by PANSS positive symptom scores. This finding is consistent with the hypothesis that MIN-101 has a direct and specific effect on negative symptoms.

General psychopathology was observed to improve during the extension phase for the 32 and 64 mg groups, as shown by reductions in the PANSS general psychopathology subscale score and total PANSS score.

MIN-101 was generally reported to be well tolerated through the entire 36-week period.  QTcF, a measurement of cardiac function, was closely monitored throughout the study, and discontinuation criteria based on QTcF prolongation were incorporated in the protocol.  As previously announced, two patients out of 162 who received MIN-101 in the core phase were discontinued based upon these criteria; both of these patients received the higher dose (64 mg). In the extension phase no additional patients were discontinued.  The extension data also confirm that MIN-101 at the doses tested did not have an effect on extra-pyramidal symptoms (EPS), prolactin or weight gain.

About MIN-101

MIN-101 is a drug candidate with equipotent affinities for sigma 2 and 5‑hydroxytryptamine-2A (5-HT2A) and lower affinity at α1-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.

About Schizophrenia and Negative Symptoms
As described by the National Institute of Mental Health, schizophrenia is a chronic and severe disorder that affects how a person thinks, feels and acts1.  In 2015 approximately 3.2 million people suffered from schizophrenia in the U.S., Japan and the five major European markets.  Schizophrenic patients suffer from positive, negative and cognitive symptoms.  Negative symptoms are disruptions to normal emotions and behaviors that may signal social withdrawal.  Patients may be socially inhibited, lack the ability to begin and sustain planned activities, or speak little even when forced to interact.  Negative symptoms account for a substantial portion of the morbidity associated with schizophrenia2.  They persist chronically throughout an individual patient’s lifetime and increase with severity over time.

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, which recently completed a Phase IIb clinical trial for schizophrenia; MIN-117, which recently completed a Phase IIa clinical trial development for MDD;  MIN-202 (JNJ-42847922), which recently completed Phase IIa and Phase Ib clinical trials for insomnia and MDD, respectively; 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; the clinical and therapeutic potential of MIN-101; our ability to successfully develop and commercialize MIN-101; 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 our therapeutic product discovery and development efforts with MIN-101 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 June 30, 2016, filed with the Securities and Exchange Commission on August 4, 2016.  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.

1 https://www.nimh.nih.gov/health/publications/schizophrenia-booklet-12-2015/index.shtml

2 Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, American Psychiatric Association.

 

         Contact:
         
         William B. Boni
         VP, Investor Relations/
         Corp. Communications
         Minerva Neurosciences, Inc.
         (617) 600-7376

Om NASDAQ OMX

NASDAQ OMX
NASDAQ OMX
One Liberty Plaza - 165 Broadway
NY 10006 New York

+1 212 401 8700http://www.nasdaqomx.com

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

Nasdaq Welcomes I-AM Capital Acquisition Company (Nasdaq: IAMXU) to The Nasdaq Stock Market17.8.2017 18:50Pressemelding

NEW YORK, Aug. 17, 2017 (GLOBE NEWSWIRE) -- I-AM Capital Acquisition Company (Nasdaq:IAMXU), a blank check company formed for the purpose of effecting a merger, capital stock exchange, asset acquisition, stock purchase, reorganization or similar business combination with one or more businesses, celebrated its initial public offering (IPO) on The Nasdaq Stock Market.  I-AM Capital's founders, Chief Executive Officer F. Jacob Cherian and Chief Financial Officer Suhel Kanuga, have been focused on investing into India over the last decade, with the distinction of completing the first listed-SPAC investment in India. "Through our keen focus and unique accomplishments in India over the last decade, we have seen our investment thesis bear fruit: India's prominence and rise on the world stage, its distinction as being one of the fastest growing major economies of the world, and its strong vibrant consumer demographics. We believe these factors are aligning well now,

Tetraphase Pharmaceuticals Announces Submission and Validation of IV Eravacycline Marketing Authorization Application by European Medicines Agency17.8.2017 14:30Pressemelding

WATERTOWN, Mass., Aug. 17, 2017 (GLOBE NEWSWIRE) -- Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a clinical-stage biopharmaceutical company developing novel antibiotics to treat life-threatening multidrug- resistant (MDR) infections, today announced that the Marketing Authorization Application (MAA) for IV eravacycline for the treatment of complicated intra-abdominal infections (cIAI) has been submitted and was validated by the European Medicines Agency (EMA). Eravacycline is a novel, fully-synthetic fluorocycline antibiotic being developed for the treatment of serious infections, including those caused by multidrug-resistant (MDR) pathogens. The MAA filing is based on data from the phase 3 IGNITE1 clinical trial in which eravacycline was well tolerated and demonstrated statistical non-inferiority to ertapenem using the primary endpoint of clinical response at the test-of-cure (TOC) visit. "The MAA filing represents a significant milestone for Tetraphase as it is our

RedHill Biopharma Announces U.S. Commercialization Agreement for FDA-Approved GI Product Esomeprazole Strontium Delayed-Release Capsules17.8.2017 13:00Pressemelding

RedHill was granted the exclusive rights to promote Esomeprazole Strontium Delayed-Release (DR) Capsules to gastroenterologists in certain U.S. territories Esomeprazole Strontium DR Capsules 49.3 mg is an FDA-approved, proprietary, prescription proton pump inhibitor (PPI), indicated for adults for the treatment of gastroesophageal reflux disease (GERD) and other gastrointestinal (GI) conditions   RedHill expects to initiate the U.S. promotion of Esomeprazole Strontium  DR Capsules 49.3 mg  in the coming weeks   Esomeprazole Strontium  DR Capsules 49.3 mg  will be the third commercial GI product to be promoted by RedHill in the U.S.    RedHill's GI-focused sales force currently promotes two GI s

Brand Industrial Services Announces Agreement to Acquire Venko Groep BV16.8.2017 19:40Pressemelding

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 15:38Pressemelding

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 14:00Pressemelding

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

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

Besøk vårt presserom