Reducing time, sample handling, and staff requirements for complement activation monitoring in clinical trials



 DESCRIPTION (provided by applicant): Despite overwhelming evidence that the complement system is involved in kidney and cardiovascular outcomes, stringent technical requirements limit its inclusion in clinical trials and diagnostics. Current protocols require careful sample collectin, immediate freezing, and shipping to only a few specialized labs. As a result, while complement system proteins C3 and C4 are routinely measured in autoimmune disease clinics, proteolytically activated split products known to mediate active inflammatory and autoimmune processes are rarely assessed. Kypha Inc. is developing an integrated point-of-care (POC) platform to make reliable complement data more accessible to clinical trials and diagnostic applications. These efforts are timely due to recent therapeutic development focused on anti-inflammatory strategies including complement inhibition for extracorporeal therapies (such as hemodialysis), autoimmunity, transplant rejection, and other conditions. Milestones in this Phase I proposal will demonstrate the feasibility of using advanced multiplex quantitative lateral flow assays in the point of care as a solution that decreases the resources required to measure complement activation and inflammation in clinical trials, paving the way for their full utility inthe diagnosis and management of acute and chronic renal and vascular inflammatory diseases.