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Development of a novel peptide therapeutic for traumatic brain injury

开发一种新型肽治疗创伤性脑损伤

基本信息

批准号：
10602192
负责人：
Aman Mann
金额：
$ 129.1万
依托单位：
AIVOCODE, LLP
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-04-01 至 2025-03-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10602192
关键词：
Address Air Animals Anti-Inflammatory Agents Area Bacteriophages Behavior Binding Binding Proteins Biological Availability Biological Markers Brain Brain Death Brain Injuries Chemistry Clinical Clinical Trials Closed head injuries Collaborations Communication Consultations Contusions Data Department of Defense Development Dose Drug Kinetics Family suidae Financial Hardship Formulation Frequencies Future Genetic Transcription Goals Guidelines Histology Histopathology Hour Human Image Injectable Injury Intervention Investigation Investigational Drugs Laboratory Markers Lead Lesion Libraries Medically Underserved Area Miniature Swine Modeling National Institute of Neurological Disorders and Stroke Nature Neurologic Neuroprotective Agents Penetration Peptides Persons Pharmaceutical Preparations Pharmacology Study Phase Physiological Plasma Play Process Property Proteins Rattus Recovery Recovery of Function Rodent Rodent Model Role Safety Severities Side Site Sprague-Dawley Rats Synaptic plasticity TBI Patients TBI treatment Tenascin Testing Therapeutic Agents Therapeutic Studies Time Tissues Toxic effect Toxicokinetics Toxicology Translations Trauma Traumatic Brain Injury Treatment Efficacy United States Food and Drug Administration axonal pathfinding base central nervous system injury clinical development drug development efficacy study experimental study first-in-human healing imaging biomarker improved in vivo innovation manufacture mouse model myelination neuroprotection novel novel therapeutic intervention novel therapeutics peptide drug pharmacokinetics and pharmacodynamics pharmacologic porcine model pre-Investigational New Drug meeting pre-clinical preclinical development preclinical study primary outcome research clinical testing response safety study screening secondary outcome therapeutic candidate tissue injury

项目摘要

PROJECT SUMMARY This Direct-to-Phase II application aims to complete the preclinical development activities required for the development of a novel treatment for moderate to severe traumatic brain injury (TBI), an area with a huge unmet need. TBI is characterized by an impact to the brain followed by a development of a secondary injury that results from processes initiated by the trauma. The secondary injury occurs in the hours and days following the primary injury and plays a large role in the brain damage and death that results from TBI. There are currently general management guidelines for patients with TBI with no specific neuroprotective interventions available. We propose to validate a novel therapeutic agent for treatment of moderate to severe TBI. AivoCode, Inc. has developed CAQK, a proprietary peptide, for the management of TBI. CAQK specifically targets both penetrating and contusion type of brain injuries and has a pluripotent effect when administered early on in the injury by limiting the secondary damage in TBI. This effect results in improved healing of the injuries as well functional recovery in rodent model of TBI. In this application, we will conduct efficacy studies in pig model of focal TBI and generate a pharmacokinetic profile in a gyrencephalic model of TBI. We will also complete pre-clinical studies that include CMC, formulation development and non-GLP toxicology studies needed for an IND (Investigational New Drug) application for the Food and Drug Administration (FDA) to initiate clinical trials of CAQK for treatment of TBI.

项目摘要本直接进入II期申请旨在完成临床前开发活动开发一种新的治疗中度至重度创伤性脑损伤的方法所需的 (TBI)这是一个有着巨大未满足需求的领域。TBI的特点是对大脑的影响，由创伤引发的过程导致的继发性损伤的发展。的继发性损伤发生在原发性损伤后的数小时和数天内，创伤性脑损伤导致的脑损伤和死亡目前，管理层没有特定神经保护干预措施的TBI患者指南。我们提出验证用于治疗中度至重度TBI的新型治疗剂。 AivoCode公司开发了CAQK，一种专有肽，用于TBI的管理。CAQK 专门针对穿透性和挫伤型脑损伤，并具有多能当在损伤早期给药时，通过限制TBI中的继发性损伤而产生效果。这在啮齿类动物模型中，创伤性脑损伤在本申请中，我们将在猪局灶性TBI模型中进行疗效研究，并生成在脑回模型中的TBI的药代动力学曲线。我们还将完成临床前研究，包括CMC、制剂开发和非GLP毒理学研究，向美国食品药品监督管理局（FDA）提交IND（研究性新药）申请，启动CAQK治疗TBI的临床试验。