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PDE4B Inhibitors For Treating Major Depression

PDE4B 抑制剂治疗重度抑郁症

基本信息

批准号：
8705018
负责人：
Mark E Gurney
金额：
$ 99万
依托单位：
TETRA DISCOVERY PARTNERS, INC.
依托单位国家：
美国
项目类别：
财政年份：
2011
资助国家：
美国
起止时间：
2011-05-23 至 2016-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8705018
关键词：
Active Sites Address Anti-Inflammatory Agents Anti-inflammatory Antidepressive Agents Arteritis Award Back Behavior Binding Biological Assay Biological Markers Brain Brain-Derived Neurotrophic Factor Businesses C-terminal Chemicals Clinical Trials Cognition Cyclic AMP Depressed mood Disease Dose Drug Design Drug effect disorder Enzymes Ferrets Funding Genetic Genetic Polymorphism Glutamine Goals Health Heart Diseases Human In Vitro Inflammation Inflammatory Inflammatory Bowel Diseases Inhibitory Concentration 50 Injury Interferons Investigational Drugs Investigational New Drug Application Lead Learned Helplessness Legal patent Ligands Lipopolysaccharides Macrophage-1 Antigen Major Depressive Disorder Marketing Measures Mental Depression Metabolic Modeling Mus NOEL Names National Institute of Mental Health Nausea PDE4B Pathology Patients Permeability Pharmaceutical Preparations Pharmacology Pharmacology and Toxicology Phase Pike fish Plasma Proteins Positron-Emission Tomography Post-Traumatic Stress Disorders Pre-Clinical Model Prevalence Production Protein Binding Protein Isoforms Psoriasis Psychological reinforcement Qualifying Rattus Research Personnel Safety Schedule Schizophrenia Series Small Business Innovation Research Grant Solubility Structure Structure-Activity Relationship Swimming TNF gene Tail Suspension Testing Therapeutic Time Tissue Inhibitor of Metalloproteinase-1 Toxic effect Traumatic Brain Injury United States Food and Drug Administration Viral World Health Organization base burden of illness design experience genotoxicity improved in vitro Assay in vivo inhibitor/antagonist injured novel phosphodiesterase IV pre-clinical preclinical safety preclinical toxicity public health relevance

项目摘要

DESCRIPTION (provided by applicant): Tetra Discovery Partners proposes to develop a new treatment for major depressive disorder based on inhibition of phosphodiesterase 4B (PDE4B). Uniquely, the Tetra drug will address inflammation as a contributor to depression. This is a new mechanism of action for an antidepressant drug which should prove complimentary to current therapeutics. Addressing inflammation will target currently untreatable patients, such as those receiving interferon-a (IFNa) for viral illness, depressed patients with co-morbid psoriasis, inflammatory bowel disease, traumatic brain injury, or post-traumatic stress disorder. Given the limitations of current treatments, there is a need for new medications with novel mechanisms of action. The prevalence of major depression is staggering with around 20% of people experiencing depression at some point in their lives. The company estimates that 10-20% of patients with depression have inflammation and will be ideal candidates for the Tetra drug. The market for antidepressant drugs is expected to grow at a CAGR of 3.2% to US $10.9 billion by 2018. The World Health Organization predicts that by 2020, depression will rival heart disease as the health disorder with the highest disease burden in the world. The Phase II SBIR project will complete chemical optimization of a PDE4B inhibitor for use in human and the preclinical safety and toxicity studies needed for filing an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) for human clinical trials in major depression.

描述(由申请人提供)：利乐发现合作伙伴建议开发一种基于抑制磷酸二酯酶4B(PDE4B)的严重抑郁障碍的新疗法。独一无二的是，利乐药物将解决炎症问题，认为它是导致抑郁症的因素。这是一种抗抑郁药物的新作用机制，应该被证明是对现有疗法的补充。解决炎症的目标将是目前无法治疗的患者，如因病毒性疾病而接受干扰素-a(IFNA)治疗的患者，合并牛皮癣、炎症性肠病、创伤性脑损伤或创伤后应激障碍的抑郁症患者。鉴于目前治疗的局限性，需要具有新作用机制的新药。严重抑郁症的患病率令人震惊，约20%的人在生活中的某个时候经历过抑郁症。该公司估计，10-20%的抑郁症患者患有炎症，将是Tetra药物的理想候选药物。到2018年，抗抑郁药物市场预计将以3.2%的复合年增长率增长至109亿美元。世界卫生组织预测，到2020年，抑郁症将与心脏病相提并论，成为世界上疾病负担最高的健康疾病。第二阶段SBIR项目将完成用于人类的PDE4B抑制剂的化学优化，以及向美国食品和药物管理局(FDA)提交用于治疗严重抑郁症的人类临床试验所需的临床前安全性和毒性研究。