NASDAQ OMX

American Journal of Psychiatry Publishes Minerva Neurosciences' MIN-101 Phase 2b Trial Results for Treatment of Negative Symptoms in Schizophrenia

Dela

WALTHAM, Mass., July 31, 2017 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ:NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system disorders, today announced that the American Journal of Psychiatry has published online results from its previously reported Phase 2b clinical trial of MIN-101. MIN-101 is a novel compound with affinities for sigma2 and 5HT2A receptors but no direct activity on dopamine receptors. In this regard, MIN-101 differs from drugs currently indicated for schizophrenia, all of which directly interfere with dopamine neurotransmission by antagonizing dopamine receptors.

The manuscript, entitled "Efficacy and Safety of MIN-101: A 12-Week Randomized, Double-Blind, Placebo-Controlled Trial of New Drug in Development for the Treatment of Negative Symptoms in Schizophrenia," and be found online at http://www.medical-reprints.com/US-MN-AJP-Davidson.

The key finding from the publication is that MIN-101 achieved its primary outcome in the trial, demonstrating statistically significant superiority over placebo in improving negative symptoms in schizophrenia patients as measured by the pentagonal negative symptoms cluster of the Positive and Negative Syndrome Scale (PANSS). The improvement in negative symptoms was shown for both doses tested: 32 milligrams (mg): p = 0.024 effect size = 0.45, and 64 mg: p = 0.004 effect size = 0.57. 

Supporting these findings were similar and concomitant improvements on several secondary outcome measures, including PANSS cluster analyses of negative symptoms, the PANSS total score, the Clinical Global Impression (CGI) and the Brief Negative Symptom Scale (BNSS). Psychosis measured by the PANSS Positive symptoms subscale remained stable during the trial, suggesting that the improvement in negative symptoms associated with MIN-101 was specific and not a pseudo-effect secondary to improvements in psychosis.  

MIN-101 also demonstrated good tolerability, with no weight gain or other metabolic abnormalities, no clinically significant changes in vital signs, routine laboratory values, sedation and extra-pyramidal symptoms (EPS).   The lack of observed adverse effects associated with MIN-101 treatment as compared to placebo helped to preserve the blinding of the trial, further supporting the validity and specificity of the improvement observed in negative symptoms. 

"Negative symptoms, which tend to persist even after psychosis improves, are the main impediment to social reintegration of schizophrenia patients," 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 and an expert in the rehabilitation of schizophrenia patients. "No drugs in the U.S. are currently indicated for negative symptoms in schizophrenia, and a drug with specific effects on negative symptoms has a real chance to improve the day-to-day social and vocational functioning of patients affected by this disease."

"The findings published in the American Journal of Psychiatry are noteworthy in that MIN-101 was shown to improve negative symptoms without blocking dopamine receptors, unlike other drugs indicated for schizophrenia," said Dr. Harvey.  "As such, it may be better tolerated by patients and may improve drug adherence, which is particularly problematic in treating schizophrenia."  Dr. Harvey was not involved in the design or the conduct of the Phase 2b trial with MIN-101.

"The publication of these data by a prestigious journal like the American Journal of Psychiatry is important for Minerva because it reflects a peer-reviewed recognition by the scientific and medical community of a new and innovative potential approach to alleviating the most debilitating symptoms in patients suffering from schizophrenia," said Dr. Remy Luthringer, president and chief executive officer of Minerva.

Following a recent "end-of-Phase 2" meeting with the U.S. Food and Drug Administration (FDA), Minerva expects to initiate a pivotal Phase 3 trial with MIN-101 to treat negative symptoms in schizophrenia in the second half of 2017. 

About the American Journal of Psychiatry

The American Journal of Psychiatry is the official journal of the American Psychiatric Association (APA), the oldest medical association in the country, founded in 1844. It is published monthly and is focused on a broad spectrum of issues and advances in the diagnosis and treatment of mental illness.  The APA is the largest psychiatric association in the world with more than 37,000 physician members specializing in the diagnosis, treatment, prevention and research of mental illness. 

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-202 (JNJ-42847922), in clinical development for insomnia and major depressive disorder (MDD); MIN-117, in clinical development for 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 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; 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.

Contact:

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 OMX
NASDAQ OMX



Följ NASDAQ OMX

Abonnera på våra pressmeddelanden.

Senaste pressmeddelandena från NASDAQ OMX

ERYTECH Confirms Strategic Focus of Eryaspase on Solid Tumors and Ceases Development in Acute Lymphoblastic Leukemia25.6.2018 00:06Pressmeddelande

Conference call on Monday, June 25th at 2:30 pm CET/8:30 am EDT Focuses development efforts on solid tumor indications Confirms planned launch of company-sponsored randomized Phase 2 trial in first-line pancreatic cancer, in addition to ongoing launch of Phase 3 trial in second-line pancreatic cancer. Expands eryaspase production capacity in the United States and France Plans to cease development in acute lymphoblastic leukemia (ALL), including withdrawal of European Marketing Authorization Application (MAA) LYON, France and CAMBRIDGE Mass., June 24, 2018 (GLOBE NEWSWIRE) -- ERYTECH Pharma (Euronext:ERYP) (Nasdaq:ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, today announced that it will focus its development efforts for its product candidate eryaspase on the potential treatment of selected solid tumor indications. The company also announced that it plans to cease its development pro

CORRECTING and REPLACING -- PRESS ALERT & INVITATION: Arbitrade to Hold a Press Conference on June 28th From Bermuda - Its New Global Headquarters23.6.2018 14:00Pressmeddelande

NEW YORK, June 23, 2018 (GLOBE NEWSWIRE) -- In a press release issued under the same headline earlier today by Arbitrade, please note that the correct date of the event is Thursday, June 28, 2018 at 8:00 a.m. EDT. The corrected release follows: This is an invitation to all media following Arbitrade and/or covering the cryptocurrency markets. You are invited to join Arbitrade's Chairman, Len Schutzman, and management who will discuss their progress toward establishing Arbitrade as a world-class cryptocurrency exchange and coin company. They will also discuss their move and incorporation into Bermuda, one of the world's best regulated jurisdictions and a platform from which Arbitrade will reach out to several international markets. It will be a lively discussion that will also include details of the many economic and social advantages and new jobs that companies, like Arbitrade, will bring to countries in which they settle and do business around the world. Details of how to access the pr

15th Consecutive Nasdaq Closing Cross Sets Record for Number of Shares Traded During 2018 Russell US Indexes Reconstitution22.6.2018 23:19Pressmeddelande

NEW YORK, June 22, 2018 (GLOBE NEWSWIRE) -- Nasdaq (Nasdaq:NDAQ) today announced the Nasdaq Closing Cross had a record day as it was used for the 15th consecutive year to rebalance Nasdaq-listed securities in the entire family of Russell U.S. Indexes, part of leading global index provider FTSE Russell, during their annual reconstitution. A record 1.188 billion shares representing $39.26 billion were executed in the Closing Cross in 0.935 seconds across some 2,591 Nasdaq-listed stocks. This compares to 2017, when Nasdaq executed 972 million shares representing $28.9 billion executed in 0.861 seconds across 2,499 Nasdaq-listed stocks. "Today, we saw a record-breaking performance for the Nasdaq Closing Cross, which benefits issuers and investors alike with transparent and efficient price discovery," said Tom Wittman, Head of Global Equities and Executive Vice President of Global Trading and Market Services at Nasdaq. "The rebalance is an important event to ensure that the Russell U.S. ind

PRESS ALERT & INVITATION: Arbitrade to Hold a Press Conference on June 28th From Bermuda - Its New Global Headquarters22.6.2018 22:29Pressmeddelande

NEW YORK, June 22, 2018 (GLOBE NEWSWIRE) -- This is an invitation to all media following Arbitrade and/or covering the cryptocurrency markets. You are invited to join Arbitrade's Chairman, Len Schutzman, and management who will discuss their progress toward establishing Arbitrade as a world-class cryptocurrency exchange and coin company. They will also discuss their move and incorporation into Bermuda, one of the world's best regulated jurisdictions and a platform from which Arbitrade will reach out to several international markets. It will be a lively discussion that will also include details of the many economic and social advantages and new jobs that companies, like Arbitrade, will bring to countries in which they settle and do business around the world. Details of how to access the press briefing webcast are as follows: Please register now for the upcoming Arbitrade Conference Call: Date: Wednesday, June 27, 2018 Time: 8:00 a.m. EST We recommend that you connect to the meeting at l

Northland Power's Hai Long Offshore Wind Project Awarded Additional 744 Megawatts in Taiwan Auction22.6.2018 14:15Pressmeddelande

TORONTO, June 22, 2018 (GLOBE NEWSWIRE) -- Northland Power Inc. ("Northland") (TSX:NPI) today announced that the Taiwan Bureau of Energy ("BOE") has awarded 232 megawatts ("MW") to the Hai Long 2 offshore wind farm ("Hai Long 2") and 512 MW to the Hai Long 3 offshore wind farm ("Hai Long 3") under Taiwan's offshore wind auction program. These awards are separate from and in addition to the 300 MW in 2024 that Hai Long 2 was allocated by the Taiwan BOE on April 30, 2018 under Taiwan's Feed-in-Tariff ("FIT") program. Northland and its partner Yushan Energy Co. Ltd. ("Yushan Energy") own 60% and 40%, respectively, of Hai Long 2 and Hai Long 3. This is another significant step for Northland in Taiwan, with a second and third project progressing to connect to Taiwan's grid in 2025, subject to securing 20-year power purchase agreements. Taken together with the FIT award, the Hai Long 2 and Hai Long 3 offshore wind farms now total 1,044 MW of offshore wind capacity in Taiwan. Northland is bui

Williams Scotsman to Acquire ModSpace22.6.2018 13:09Pressmeddelande

Creates an industry-leading specialty rental services provider with over $1 billion of combined revenue and over 160,000 rental units across North America Leverages, and further strengthens, Williams Scotsman's scalable operating platform to capture an estimated $60 million of cost synergies Combines the best of both companies' go-to-market strategies, benefiting our customers and accelerating the expansion of Williams Scotsman's turnkey "Ready To Work" solutions across a broader asset base and enhanced branch network Total enterprise value of approximately $1.1 billion represents 6.6x ModSpace's Adjusted EBITDA for the twelve month period ended March 31, 2018, inclusive of forecast cost synergies and the expected value of acquired tax attributes1 ,2 BALTIMORE, June 22, 2018 (GLOBE NEWSWIRE) -- WillScot Corporation (NASDAQ:WSC) ("Williams Scotsman") the leading specialty rental services provider of innovative modular space and portable storage solutions across North America, today anno

I vårt pressrum kan du läsa de senaste pressmeddelandena, få tillgång till pressmaterial och hitta kontaktinformation.

Besök vårt pressrum