Minerva Neurosciences Announces Findings Showing Effect of Roluperidone on Brain-Derived Neurotrophic Factor (BDNF)
WALTHAM, Mass., Aug. 22, 2018 (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 findings from a recent pre-clinical study that provide evidence of the effect of roluperidone (MIN-101) on BDNF. This neurotrophin, which is the most widely distributed member of this class of proteins in the brain, has been associated with neurogenesis, neuroplasticity, neuroprotection, synapse regulation, learning, and memory.1 Its involvement in schizophrenia has also been described.2
Data from this study are being presented today at the Medicxi Forum in Venice, Italy showing that after three days of administration, roluperidone has been observed to significantly increase the release of BDNF in cultured brain hippocampal neurons in a dose dependent manner. The level of BDNF release following the administration of roluperidone increased by approximately 20 percent, comparable to the effect shown by pridopidine, the reference molecule used in the study. Pridopidine is currently under development for Huntington disease.3
Dysregulation of BDNF has been described in the pathophysiology of schizophrenia and several other neuro-psychiatric disorders. Therefore, in addition to the known neurotransmitter pathways targeted by roluperidone, particularly the serotoninergic 5-HT2A and the sigma2 pathways, the effect of roluperidone on BDNF suggests that this investigational compound may have the potential for disease modification and improved neuroplasticity.
“These findings, along with the clinical results seen during the phase 2b study, suggest the potential of roluperidone to change the overall course of schizophrenia,” said Dr. Remy Luthringer, Executive Chairman and Chief Executive Officer of Minerva. “In addition, the BDNF findings are paving the way to explore roluperidone’s therapeutic potential beyond schizophrenia.”
BDNF is a member of a family of proteins called neurotrophins that play an important role in the formation and function of neural connections. An emerging body of evidence has pointed to a link between BDNF and CNS disorders. Epigenetic changes in the BDNF gene have been shown to be related to the pathophysiology of schizophrenia, and the reduced expression of BDNF has been identified in the frontal cortex and hippocampus of the brain in patients with schizophrenia.4
Researchers believe that lower than normal levels of BDNF may affect the pathogenesis of schizophrenia by contributing to altered brain development and abnormalities in neuroplasticity and synaptic function. These disturbances may explain certain morphological and neurochemical characteristics in the brains of patients with schizophrenia.5
Furthermore, a functional polymorphism in the BDNF gene has been observed to interact with environmental factors in the development of psychoses including schizophrenia and bipolar disorders.6 Additional studies have found an association between higher levels of BDNF and improved cognitive function in schizophrenic patients and improved neuropsychological function.7
Roluperidone is a drug candidate with equipotent affinities for 5‑hydroxytryptamine-2A (5-HT2A) and sigma2 and at lower affinity levels, α1-adrenergic receptors. Roluperidone exhibits no affinity for dopaminergic, muscarinic, cholinergic and histaminergic receptors. Roluperidone 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.
A pivotal Phase 3 clinical trial is ongoing with roluperidone as monotherapy for negative symptoms in patients diagnosed with schizophrenia. Approximately 500 patients are expected to be enrolled at approximately 60 clinical sites in the U.S. and Europe. Top-line results from the 12-week double blind phase of this trial are expected in the first half of 2019.
About Minerva Neurosciences:
Minerva Neurosciences, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of a portfolio of product candidates to treat CNS diseases. Minerva’s proprietary compounds include: roluperidone (MIN-101), in clinical development for schizophrenia; MIN-117, in clinical development for major depressive disorder (MDD); seltorexant (MIN-202 or 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 scope of current clinical trials and results of clinical trials with roluperidone, seltorexant, MIN-117 and MIN-301; the timing and scope of future clinical trials and results of clinical trials with these compounds; the clinical and therapeutic potential of these compounds; our ability to successfully develop and commercialize our therapeutic products; 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 roluperidone, seltorexant, MIN-117 and MIN-301 will advance further in the clinical trials process and whether and when, if at all, they will receive final approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies and for which indications; whether any of our therapeutic products 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 June 30, 2018, filed with the Securities and Exchange Commission on August 2, 2018. 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.
1 BDNF and schizophrenia: from neurodevelopment to neuronal plasticity, learning and memory, R. Nieto et al, Frontiers in Psychiatry, June 2013, Volume 4 Article 45, https://doi.org/10.3389/fpsyt.2013.00045
2 Childhood trauma interacted with BDNF Val66Met influence schizophrenic symptoms, Xiao-jiao Bi et al, Medicine, http://dx.doi.org/10.1097/MD.0000000000010160
3 Pridopidine activates neuroprotective pathways impaired in Huntington Disease, M. Geva et al, Human Molecular Genetics, 2016, Volume 25 Number 18, doi:10.1093/hmg/ddw238
4 Effects of Antipsychotic Drugs on the Epigenetic Modification of Brain-Derived Neurotrophic Factor Gene Expression in the Hippocampi of Chronic Restraint Stress Rats, Mi Kyoung Seo et al, https://doi.org/10.1155/2018/2682037
5 BDNF and schizophrenia: from neurodevelopment to neuronal plasticity, learning and memory, R. Nieto et al, Frontiers in Psychiatry, June 2013, Volume 4 Article 45
6 Childhood trauma interacted with BDNF Val66Met influence schizophrenic symptoms, Xiao-jiao Bi et al, Medicine, http://dx.doi.org/10.1097/MD.0000000000010160
7 BDNF (brain-derived neurotrophic factor) serum levels in schizophrenic patients with cognitive deficits, N. Utami et al, doi:10.1088/1755-1315/125/1/012181
One Liberty Plaza - 165 Broadway
NY 10006 New York
GlobeNewswire is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.
Følg saker fra GlobeNewswire
Registrer deg med din epostadresse under for å få de nyeste sakene fra GlobeNewswire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra GlobeNewswire
Apellis Pharmaceuticals Presents Data from Ongoing APL-2 Phase 2 Study in Patients with Cold Agglutinin Disease and Warm Antibody Autoimmune Hemolytic Anemia at 24th European Hematology Association (EHA) Congress15.6.2019 16:00:00 CEST | Pressemelding
CRESTWOOD, Ky. and WALTHAM Mass., June 15, 2019 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals Inc. (Nasdaq:APLS), a clinical-stage biopharmaceutical company focused on the development of novel therapeutic compounds to treat disease through the inhibition of the complement system, today announced updated data from its Phase 2 PLAUDIT study of APL-2 in patients with autoimmune hemolytic anemia (AIHA), including cold agglutinin disease (CAD) and warm antibody autoimmune hemolytic anemia (wAIHA). Data from the PLAUDIT trial will be presented in an oral presentation today at the 24th Annual Congress of the European Hematology Association (EHA), held in Amsterdam, the Netherlands. In the ongoing PLAUDIT study, 13 patients with CAD have been enrolled to receive subcutaneous APL-2 treatment, of which 10 patients have been on APL-2 for at least 168 days. The trial has also enrolled 11 patients with wAIHA, 8 of which were Direct Antiglobulin Test (DAT) C3+ (C3+ wAIHA); 5 of the C3+ wAIHA patients
Carpenter Technology and BMT Aerospace Combine Expertise in Redesign and Production of Additively Manufactured Aerospace Component14.6.2019 15:17:00 CEST | Pressemelding
LE BOURGET, France, June 14, 2019 (GLOBE NEWSWIRE) -- Carpenter Technology Corporation (NYSE:CRS) and Belgium-based BMT Aerospace today announced their cooperation in the development of an additively manufactured (AM) aerospace pinion, using Carpenter Technology’s Custom 465® Stainless. BMT Aerospace and its subsidiary BMT Additive initiated the project by partnering with Carpenter Technology to produce a redesigned pinion. The redesign project was initiated to enable the benefits of additive manufacturing using high quality, printable material that would attain the high-performance expectations for the application. “BMT Aerospace strongly believes in the disruptive potential of additive manufacturing and its possibilities in aerospace,” explained Ewald Goossens, Business Unit Manager of BMT Additive. “As a small player in the market, we strongly believe in cooperation opportunities like these, where each partner can rely and build on a project, starting from its own expertise. Our spe
Immunophotonics and Clinical Laserthermia Systems Announce Immuno-Oncology Research Collaboration and Clinical Trials for Cancer Patients with Solid Tumors14.6.2019 13:00:00 CEST | Pressemelding
Collaboration will Combine Immunophotonics’ Proprietary Drug, IP-001, and CLS’s TRANBERG Laser Thermal Therapy System and imILT Method ST. LOUIS and LUND, Sweden, June 14, 2019 (GLOBE NEWSWIRE) -- Immunophotonics, Inc. and Clinical Laserthermia Systems, AB (STO:CLS B) (CLS) today announced they have entered into a research collaboration agreement to support a Phase 1b/2a clinical trial for cancer patients with certain solid tumor indications. The research will utilize each company’s respective products and methodologies during treatments and is intended to support early phase clinical trials facilitated by a leading clinical organization. Eligible patients with solid tumors will be treated using the locally administered CLS Immunostimulating Interstitial Laser Thermotherapy (imILT) method, followed immediately by an intratumoral injection of Immunophotonics’ lead asset, IP-001. Under the agreement, the CLS TRANBERG Laser and single-use products will be used in eligible patients enrolle
iCAD Introduces ProFound AI™ for 2D Mammography in Europe13.6.2019 14:00:00 CEST | Pressemelding
Company to showcase its newest artificial intelligence software solution, ProFound AI for 2D Mammography, in addition to ProFound AI for Digital Breast Tomosynthesis at the SIFEM Medical Conference in France NASHUA, N.H. and LILLE, France, June 13, 2019 (GLOBE NEWSWIRE) -- iCAD, Inc. (NASDAQ: ICAD), a global medical technology leader providing innovative cancer detection and therapy solutions, today announced the launch of ProFound AI™ for 2D Mammography in Europe. This software is the latest addition to iCAD’s deep-learning, artificial intelligence platform and follows the launch of ProFound AI™ for Digital Breast Tomosynthesis (DBT), which was CE Marked in March 2018 and FDA cleared in December 2018. ProFound AI for 2D Mammography and ProFound AI for DBT will both be featured in the iCAD exhibition booth (#24) at the Société Française d'Imagerie de la FEMme (SIFEM) medical conference from June 13-15, 2019 at the Grand Palais in Lille, France. “iCAD is at the forefront of the fight ag
Telix Pharmaceuticals and Eczacıbaşı-Monrol Sign Manufacturing and Distribution Agreement13.6.2019 13:54:00 CEST | Pressemelding
MELBOURNE, Australia and ISTANBUL, Turkey, June 13, 2019 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX.TLX) (“Telix”, the “Company”), a clinical-stage biopharmaceutical company focused on the development of diagnostic and therapeutic products based on targeted radiopharmaceuticals or “molecularly-targeted radiation” (MTR) has today announced that it has concluded a master services and distribution agreement with Eczacıbaşı-Monrol. Under the terms of the agreement, Telix has appointed Eczacıbaşı-Monrol as a radiopharmaceutical production partner and distributor in Turkey/Middle East/North Africa. Eczacıbaşı-Monrol is commercially active in more than 40 countries, including important growth territories that complement Telix’s current commercial strategy for the US and Europe. The parties will initially focus on the production and distribution of TLX250-CDx (89Zr-girentuximab) for imaging of renal cell carcinoma with Positron Emission Tomography (PET), including to support the ad
Highly Accurate Long-Read Sequencing of Human Genomes Leads to Discovery of Disease-Causing Variants13.6.2019 13:30:00 CEST | Pressemelding
Identification of pathogenic structural variants with SMRT Sequencing improves solve rate for rare and Mendelian diseases MENLO PARK, Calif., June 13, 2019 (GLOBE NEWSWIRE) -- While DNA sequencing tools have been useful for determining the genetic cause of many diseases, there remain a large number that are left unexplained. Recently, scientists have adopted Single Molecule, Real-Time (SMRT®) Sequencing from Pacific Biosciences of California, Inc. (Nasdaq:PACB), a leading provider of high-quality sequencing of genomes, transcriptomes and epigenomes, to study previously unsolved diseases. Many high-impact research publications report expanded variant detection in human genomes, leading to discovery of disease-causing variants and genes underlying rare and Mendelian disorders. In a Nature Communications publication, scientists report that most structural variants (SVs) and large indels are undetected in today’s human genetic studies, which likely accounts for some of the missing heritabi