Minerva Neurosciences Announces Enrollment of First Patient in Phase 2b Trial Comparing Seltorexant (MIN-202) Versus Quetiapine as Adjunctive Therapy to Antidepressants in Patients With...
Minerva Neurosciences Announces Enrollment of First Patient in Phase 2b Trial Comparing Seltorexant (MIN-202) Versus Quetiapine as Adjunctive Therapy to Antidepressants in Patients With Major Depressive Disorder
WALTHAM, Mass., Dec. 21, 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 enrollment of the first patient in a Phase 2b clinical trial (NCT03321526) comparing seltorexant (MIN-202) versus quetiapine as adjunctive therapy in patients with major depressive disorder (MDD) who have responded inadequately to antidepressant therapy.
The primary objective of this multi-center, double-blind, randomized, flexible-dose, parallel-group study is to assess the efficacy of flexibly dosed seltorexant compared to flexibly dosed quetiapine as adjunctive therapy to a baseline antidepressant drug in delaying time to all-cause discontinuation of study drug over a 6-month treatment period. Time to all-cause discontinuation is defined as the number of days from administration of the first dose of study drug to administration of the last dose of study drug.
"Preclinical studies have demonstrated that inhibition of orexin 2 receptors diminishes stress-induced activation of the HPA (hypothalamic-pituitary-adrenal) axis, a major part of the neuroendocrine system that is implicated in the pathophysiology of mood disorders and controls reactions to stress," said Dr. Remy Luthringer, chief executive officer of Minerva. "We expect that this trial will provide important clinical data on the potential role of an orexin 2 inhibitor in treating major depressive disorder."
The trial consists of three phases: a screening phase lasting up to four weeks, a six-month double-blind treatment phase and a two-week follow-up phase. Approximately 100 patients 18 to 64 years of age are planned to be randomized at approximately 34 sites in the U.S. to receive either flexibly dosed seltorexant, 20 milligrams (mg) or 40 mg, or flexibly dosed quetiapine XR, 150 mg or 300 mg. Subjects will continue to take their baseline antidepressant therapy of either an SSRI (selective serotonin reuptake inhibitor) or an SNRI (serotonin-norepinephrine reuptake inhibitor) at the same dose throughout the screening, double-blind and follow-up phases.
About Seltorexant (MIN-202)
Seltorexant is a selective orexin 2 receptor antagonist under co-development by Janssen Pharmaceutica NV and Minerva as adjunctive therapy for MDD and for the treatment of insomnia disorder. The orexin system in the brain is involved in the control of several key functions, including metabolism, stress response and wakefulness.
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 product portfolio includes: MIN-101, in clinical development for schizophrenia; seltorexant (MIN-202), 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 seltorexant in major depressive disorder, including 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 seltorexant; 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 seltorexant 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 seltorexant, if any, will be consistent with the results of past clinical trials; whether seltorexant 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 September 30, 2017, filed with the Securities and Exchange Commission on November 6, 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
XBiotech Announces Presentation of Phase 2 Open Label Extension Study Data Evaluating MABp1 for the Treatment of Hidradenitis Suppurativa19.1.2018 14:00 | Pressmeddelande
Open Label Extension Results, which Demonstrate Significant Improvements in HS Patients Previously Treated with Placebo, will be Presented at the 7th Conference of the European Hidradenitis Suppurativa Foundation (EHSF) AUSTIN, Texas, Jan. 19, 2018 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT) announced today that results from an open label extension (OLE) phase of the randomized Phase 2 study evaluating XBiotech's True Human(TM) antibody, MABp1, as a treatment for Hidradenitis Suppurativa (HS), will be presented at the European Hidradenitis Suppurativa Foundation (EHSF) Conference occurring in Rotterdam Netherlands February 7-9th. The oral presentation titled, "An open-label extension study of MABp1 targeting interleukin-1alpha for hidradenitis suppurativa (HS)" will be given by Theodora Kanni, M.D., Ph.D., Attikon University Hospital in Athens Greece, on 8 February 2018 between 1:50 and 2:50pm local time. The findings being presented come from patients that had received placebo in
The Search for #AconfidentYou Role Models Kicks Off at the Xehar Fashion Fairies Conference19.1.2018 12:00 | Pressmeddelande
Expanding their Fashion Fairies Program, Xehar Teaches and Inspires Women Through Confidence EL SEGUNDO, Calif., Jan. 19, 2018 (GLOBE NEWSWIRE) -- Today, the Xehar team announces the Xehar Fashion Fairies Conference, which takes place over three days in Los Angeles, January 19th-21st. The conference gathers aspiring fashionistas to celebrate self love, natural beauty, and learn what it takes inspire women to be more confident. With powerful keynotes, exciting breakout sessions, a fashion show and international networking opportunities, the conference is a unique blend that is new to the fashion industry. "We are searching for our 2018 Fashion Fairies who are serious about a career in fashion and want to inspire women worldwide," says Hadari Oshri, founder and CEO of Xehar. "Attendees will learn how to become one of our exclusive #AconfidentYou Fashion Fairies." Propelled by the successful launch of its existing influencer outreach, Xehar has now expanded their Fashion Fairies program t
Olympus Labs Partners with Leading Korean Fintech Company Metaps Plus19.1.2018 00:03 | Pressmeddelande
Gibraltar, Jan. 18, 2018 (GLOBE NEWSWIRE) -- Olympus Labs is quickly becoming an emerging global leader in the cryptocurrency-based financial product space, and on the heels of a successful token sale, Olympus is partnering with Seoul-based corporation Metaps Plus, a leading Korean fintech company and mobile marketing platform developer. This news comes shortly after the company announced OKEx, as its official exchange for the company's token MOT. "This is an amazing partnership for us, as it will allow us to hit the Korean market in a big way. We will be able to tap directly into the tens of millions of users on the Metaps Plus platform, allowing users to access financial products created by Olympus," said Kai Chen, CEO of Olympus Labs. "This is a key milestone as it demonstrates that Olympus products can be integrated in third party platforms such as mobile apps, wallets, exchanges, and even physical atms and pos systems, allowing users throughout the world access to Olympus products
Forward Industries Acquires Intelligent Product Solutions18.1.2018 23:54 | Pressmeddelande
WEST PALM BEACH, Fla. and HAUPPAUGE, N.Y., Jan. 18, 2018 (GLOBE NEWSWIRE) -- Forward Industries (NASDAQ:FORD) today announced the acquisition of Intelligent Product Solutions (IPS), an industry leading product design and development company based in Long Island, New York for a material consideration comprising of cash, equity, and contingent earn outs. IPS clients include leading brands in consumer electronics, medical devices, enterprise and security solution providers and Internet of Things connected solutions, including Google, Physio Control, PepsiCo, Motorola, ABInBev, Zebra and Charity Water. Commenting on the transaction, Terry Wise, CEO of Forward Industries remarked, "I am delighted and excited with the acquisition of IPS. The company is an excellent strategic fit for Forward Industries. Its expertise and strong track record in designing connected/IOT products and developing products such as the AdhereTech 'smart' pill bottle will significantly strengthen and contribute to For
VITEC to Highlight EZ TV IPTV and Digital Signage Platform in First ISE Appearance18.1.2018 21:06 | Pressmeddelande
PARIS, Jan. 18, 2018 (GLOBE NEWSWIRE) -- In its first-ever attendance at Integrated Systems Europe (ISE), VITEC, a worldwide leader in advanced video encoding and streaming solutions, will showcase EZ TV - a market-leading, broadcast-grade IPTV and digital signage platform with key installations in Europe and the U.S. Targeted to enterprises, sports stadiums and arenas, and government agencies, EZ TV combines low-latency, broadcast-quality IPTV distribution with powerful digital signage capabilities to give audiences a more engaging and interactive experience. "As Europe's largest show for AV systems integrators, ISE is the perfect forum for us to present our EZ TV IPTV platform," said Bruno Teissier, sales and marketing director, VITEC. "We're looking forward to showing ISE attendees how they can help their customers distribute broadcast-quality IPTV content and access powerful digital signage capabilities in an all-in-one, integrated solution." Designed to integrate seamlessly with a
Brookfield Asset Management Notice of 2017 Year End Results Conference Call and Webcast18.1.2018 16:12 | Pressmeddelande
Date: Thursday, February 15, 2018 Time: 11:00 a.m. (Eastern Time) BROOKFIELD, News, Jan. 18, 2018 (GLOBE NEWSWIRE) -- You are invited to participate in Brookfield Asset Management's 2017 Year End Results Conference Call & Webcast on Thursday, February 15, 2018 at 11:00 a.m. (Eastern Time) to discuss with members of senior management our results and current business initiatives. These results will be released on February 15th before 7:00 a.m. (Eastern Time) and will be available following the release on our website at www.brookfield.com "News - Press Releases." The Conference Call will also be Webcast live on our website, where it will be archived for future reference. To participate in the Conference Call, please dial 1-866-521-4909 toll free in North America, or for overseas calls please dial 1-647-427-2311 at approximately 10:50 a.m. The Conference Call will also be Webcast live at https://event.on24.com/wcc/r/1585364/9F53C4FB4A83FF2D32296C84535D6A34. For those unable to participate
I vårt pressrum kan du läsa de senaste pressmeddelandena, få tillgång till pressmaterial och hitta kontaktinformation.Besök vårt pressrum