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，开发神经激肽2受体(NK2R)激动肽，这是一种平滑肌力药物，用于恢复脊柱损伤、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，评估其在体内的短期疗效，完成临床前研究和制造，并通过研究新药(IND)使能研究和IND监管申报，使领先的候选临床药物取得进展。拟议的候选治疗药物DTI-117短期刺激NK2受体，导致内脏平滑肌收缩，缓解膀胱失禁和肠道控制。在建立分析方法和最佳表征后，该项目将进入体内和体外IND使能研究和临床试验评估。

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.