NASDAQ OMX

Minerva Neurosciences Announces Enrollment of First Patient in Phase 2b Trial of Seltorexant (MIN-202) as Adjunctive Therapy in Patients With Major Depressive Disorder

Dela

WALTHAM, Mass., Sept. 05, 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 of seltorexant (MIN-202) as adjunctive therapy to antidepressants in adult patients with major depressive disorder (MDD) who have responded inadequately to antidepressant therapy.

The primary objectives of this multi-center, double-blind, randomized, parallel group, placebo-controlled, adaptive-dose finding study are:

  • to assess the dose-response relationship and antidepressant effects of up to three doses of seltorexant; and
  • to assess the safety and tolerability of seltorexant compared to placebo as described in clinicaltrials.gov: NCT03227224.

"An important differentiator of seltorexant is its specificity for the orexin 2 receptor subtype, which is known to have a key role in controlling brain structures and pathways involved in mood and insomnia,"  said Dr. Remy Luthringer, president and chief executive officer of Minerva.  "This trial follows the observed improvements in mood in an earlier study carried out in depressed patients who received seltorexant."  

The trial consists of three phases: a screening phase lasting up to four weeks, a six-week double-blind treatment phase and a two-week post-treatment follow-up phase.  Approximately 280 patients are planned to be enrolled at more than 85 clinical sites in the U.S., Europe, Russia and Japan.

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 proprietary compounds include: 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 MIN-202 in insomnia and 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 agreements with Janssen related to seltorexant; 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 June 30, 2017, filed with the Securities and Exchange Commission on August 3, 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

Canada's CoinField cryptocurrency exchange going international with commission-free trading app moonGO through a new partnership23.7.2018 11:30Pressmeddelande

moonGO(TM) app is the fastest and most reliable way to buy/sell and store cryptocurrencies. The app allows users to convert cryptos directly to EUR/USD to be loaded into their moonGo(TM) card and be used anywhere worldwide whether they're shopping online or spending it at a physical retailer who accepts credit cards. VANCOUVER, British Columbia, July 23, 2018 (GLOBE NEWSWIRE) -- CoinField, the most advanced cryptocurrency exchange in Canada is now extending its services worldwide thanks to a new partnership with Malta's Manticore Ventures to create moonGO(TM), a powerful app designed for traders who thrive on agility, flexibility and security. With moonGO(TM), users can set up their trading accounts in about 60 seconds, withdraw fiat currency as Euro or US dollars in the form of moonGO(TM) cards, and use the moonGO(TM) cards to make purchases online or at any retailer that accepts credit cards. The moonGO(TM) app will take CoinField's sterling reputation outside of Canada and make its

UK drafts new M. genitalium guidelines: Resistance Guided Therapy to tackle antibiotic resistance23.7.2018 09:00Pressmeddelande

BASHH aiming to raise awareness of Mgen and curb rising antibiotic resistance LONDON, July 23, 2018 (GLOBE NEWSWIRE) -- The British Association of Sexual Health and HIV (BASHH) draft guidelines for the sexually transmitted infection Mycoplasma genitalium (Mgen) were posted for consultation on July 8th, 20181[link]. The guideline recommends Resistance Guided Therapy as best practice when treating an Mgen infection, with a strong recommendation for diagnostic tests to direct appropriate antibiotic treatment. Mgen is highly resistant to antibiotics, up to 50% of infections are already resistant to the first-line treatment, azithromycin.2,3 This rate may rise if infections are treated without knowledge of resistance status. The success of Resistance Guided Therapy as treatment for Mgen was published in Clinical Infectious Diseases, June 20182 [link].Cure rates increased from under 68% to over 92% by switching the first-line drug and using the SpeeDx Resistance Plus® MG* test to triage pati

LeoVegas AB: Inbjudan till presentation av LeoVegas delårsrapport för andra kvartalet 201823.7.2018 08:00Pressmeddelande

LeoVegas delårsrapport för det andra kvartalet för 2018 kommer att publiceras klockan 08:00 den 1:a augusti 2018. En webbsänd telefonkonferens kommer att hållas klockan 09:00 samma dag där Gustaf Hagman, VD och medgrundare samt Viktor Fritzén, CFO, presenterar resultatet. Det kommer att finnas möjlighet att ställa frågor via webbsändningen där även presentationsmaterialet går att följa. Webbsändningen nås på adressen: https://edge.media-server.com/m6/p/zupwii5n För att delta i telefonkonferensen via telefon, vänligen ring in på något av följande nummer: SE: +46 (0) 8 5664 2753 UK: +44 (0) 330 336 9128 US: +1 646 828 8144 Bekräftelse kod: 5362090 Webbsändningen, som även kan ses i efterhand, och presentationsmaterialet kommer att finnas tillgängligt på LeoVegas webbplats www.leovegasgroup.com under Investor Relations. För ytterligare information, vänligen kontakta: Gustaf Hagman, Group CEO och medgrundare: +46 (0) 8 410 367 66, gustaf.hagman@leovegas.com Philip Doftvik, Head of Investor

LeoVegas AB: Invitation to presentation of LeoVegas second quarter 201823.7.2018 08:00Pressmeddelande

LeoVegas interim report for the second quarter for 2018 will be published at 08:00 CET on August 1, 2018. A webcast telephone conference will be held at 09:00 CET the same day, where Gustaf Hagman, CEO and Co-founder, and Viktor Fritzén, CFO, will present the results. A possibility will be given to ask questions via the webcast and follow the presentation live. The webcast will be accessible at: https://edge.media-server.com/m6/p/zupwii5n To participate in the conference call by phone, please call one of the following numbers: SE: +46 (0) 8 5664 2753 UK: +44 (0) 330 336 9128 US: +1 646 828 8144 Confirmation code: 5362090 The webcast, which afterwards also will be available on demand, and presentation material will be published on LeoVegas website, www.leovegasgroup.com under Investor Relations. For further information, please contact: Gustaf Hagman, Group CEO: +46 (0) 8 410 367 66, gustaf.hagman@leovegas.com Philip Doftvik, Head of Investor Relations and corporate finance: +46 73 512 0

Gratomic Announces Non-Brokered Private Placement21.7.2018 19:41Pressmeddelande

TORONTO, July 21, 2018 (GLOBE NEWSWIRE) -- Gratomic Inc. ("GRAT" or the "Company") (TSX-V:GRAT) (FRANKFURT:CB81) (WKN:A143MR) is pleased to announce the offering of a non-brokered private placement of up to 20,000,000 working capital units (the "WC Unit") for up to $2,000,000 (the "Offering"). Each WC Unit is priced at $0.10 and consists of one (1) common share and one (1) common share purchase warrant ("WC Warrant"). Each WC Warrant entitles the holder to purchase one (1) common share (a "WC Warrant Share") at a price of $0.20 per WC Warrant Share until the earlier of: (i) three (3) years following the Closing of the Offering; and (ii) in the event that the closing price of the Common Shares on the TSX Venture Exchange is at least $0.30 for ten (10) consecutive trading days, and the 10th trading day (the "Final Trading Day") is at least four (4) months from the Closing Date, the date which is thirty (30) days from the Final Trading Day. Eligible Finders may receive 5% of the value of

eGain Enables Conversational Customer Service Through Apple Business Chat20.7.2018 12:30Pressmeddelande

SUNNYVALE, Calif. and NEWBURY, United Kingdom, July 20, 2018 (GLOBE NEWSWIRE) -- eGain (NASDAQ:EGAN), the leading provider of cloud-based customer engagement solutions, today announced its integration with Apple Business Chat. According to Gartner, requests for customer support through consumer mobile messaging apps will exceed requests for customer support through traditional social media by 2019*. Moreover, 56% of consumers surveyed in a Nielsen study would rather message a business than call customer service, and 67% expect to message businesses even more over the next two years. Key capabilities Among key capabilities of the integrated solution are: Enabling hundreds of millions of consumers on iPhone and iPad to interact with businesses through the Messages app Leverage eGain AI to infer customer intent, power bot conversations through messaging, route escalations to contact center agents, and guide agents through messaging conversations Provide immersive customer experiences with

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

Besök vårt pressrum