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Chemokine-receptor profiling for painful diabetic neuropathy in biological samples from human clinical trials

人体临床试验生物样本中疼痛性糖尿病神经病变的趋化因子受体分析

基本信息

批准号：
10326651
负责人：
Thomas P Richardson
金额：
$ 70.01万
依托单位：
PLUMERIA THERAPEUTICS, INC.
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-09-20 至 2023-12-15
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10326651
关键词：
Affect Alternative Splicing Amino Acid Sequence Applications Grants Area Attenuated Biological Biological Assay C-terminal Clinic Clinical Clinical Data Clinical Trials Clinical Trials Design Complex Data Development Diabetes Mellitus Diabetic Neuralgia Diagnostic Reagent Kits Drug Antagonism Drug Industry Genetic Healthcare Heart Diseases Human Individual Inflammation Inflammatory Investigational Drugs Investments Journals Knock-out Laboratories Lead Ligands Malignant Neoplasms Measures Medical Messenger RNA Methods Molecular Neuropathy Nociception Outcome Pain Patients Pharmaceutical Preparations Pharmacologic Substance Pharmacotherapy Phase Phase II Clinical Trials Phenotype Physicians Play Population Heterogeneity Process Product Labeling Protein Isoforms Publishing Quality of life Receptor Gene Role Sampling Serum Signal Transduction Small Business Innovation Research Grant Source System Therapeutic Transgenic Mice Treatment outcome Work base chemokine chemokine receptor chronic pain chronic painful condition clinical development clinical diagnostics companion diagnostics diabetic patient drug development economic cost follow-up genetic profiling in-vitro diagnostics inclusion criteria mRNA Precursor material transfer agreement monocyte chemoattractant protein 1 receptor neuroinflammation pain patient pain reduction pain relief painful neuropathy patient population patient response patient stratification phase 1 study phase 2 study phase II trial population based primary endpoint programs receptor receptor expression research clinical testing responders and non-responders response secondary endpoint success therapeutic target tool

项目摘要

Project Summary/Abstract Chronic pain is a major healthcare burden, representing economic costs of up to $635B per year, more than cancer, diabetes, and heart disease, according to a Johns Hopkins study published in the Journal of Pain. Pain is a highly heterogeneous condition comprising neuropathic, nociceptive and inflammatory components, and patient responses to currently available drugs vary greatly. A very promising approach to target various forms of pain is through antagonism of key players in neuro- inflammation. Specifically, the chemokine receptor system, a complex network of over 20 different receptors and over 80 ligands, is integral to neuroinflammatory processes and the pharmaceutical industry had been very active in developing compounds targeting individual receptors in the network. However, the biological complexity, ligand promiscuity, and receptor redundancy of the chemokine receptor system has precluded successful clinical development of the compounds and many pharma have exited the pain therapeutic area. A major limitation of successful targeting of this network is sufficient understanding of the molecular and cellular dynamics of the chemokine network, and how specific receptors vary in chronic pain conditions. In this study, we aim to determine the genetic expression of a chemokine receptor utilizing human clinical samples collected in a clinical trial evaluating a receptor antagonist. Further, we will utilize this understanding in conjunction with patient efficacy data from the clinical trials to continue the development of our lead compound, a drug that showed a statistically significant clinical signal in pain. Results from this study will enable patient stratification and effective clinical trial design by including patients with the appropriate genetic and phenotypic background and thus significantly increase the likelihood achieving primary endpoints of pain reduction in the clinic.

项目总结/文摘