LIQUID CHROMATOGRAPHY WITH TANDEM MASS SPECTROMETRY (HPLC-MS-MS) ASSAY VALIDATION AND SAMPLE TESTING

NINDS通过其BPN-Biologics网络，目前正在资助一项合作协议，用于开发神经激肽2受体（NK 2 R）激动剂肽，这是一种平滑肌肌力药物，用于恢复脊髓损伤，多发性硬化症或糖尿病患者的膀胱和肠道控制。BPN-Biologics合作协议的目标是优化先导肽-DTI-117-并评估其短期体内疗效，完成临床前研究和生产，并通过研究性新药（IND）使能研究和IND监管备案来推进先导临床候选药物。所提出的治疗候选物DTI-117短期刺激NK 2受体，引起内脏平滑肌收缩，并减轻膀胱失禁和排便控制。在建立测定和最佳表征后，该项目将进展到IND使能的体内和体外研究以及临床试验评价。

The NINDS, via its BPN-Biologics network, is currently funding a cooperative agreement for the development of a neurokinin2 receptor (NK2R) agonist peptide that is a smooth muscle inotropic drug for restoring bladder and bowel control for individuals with spinal injury, multiple sclerosis, or diabetes. The goals of the BPN-Biologics cooperative agreement are to optimize the lead peptide –DTI-117—and evaluate its short-term in vivo efficacy, complete pre-clinical studies, and manufacturing, and progress the lead clinical candidate through Investigational New Drug (IND)-enabling studies and an IND regulatory filing. The proposed therapeutic candidate DTI-117 stimulates the NK2 receptor for a short-term causing contraction of visceral smooth muscles and mitigates bladder incontinence and bowel control. Upon establishment of assays, and optimal characterization, this project will progress to IND-enabling in vivo and in vitro studies and to clinical trial evaluation.