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

Battelle Centers/Pub Hlth Res & Evaluatn, Columbus OH

Investigators

Abstract

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.