Renibus Therapeutics has introduced first-of-its-kind RBT-1 to reduce the risk of post-operative complications in patients undergoing cardiothoracic surgery.
RBT-1, a combination of stannic protoporfin and iron sucrose, has shown promising potential in inducing various pathways related to anti-inflammation, antioxidant activity, and iron scavenging.
The Phase 2 study of RBT-1, registered as NCT04564833, is a significant milestone in its development. This randomised, double-blind, multi-centre, placebo-controlled trial evaluated the efficacy of RBT-1 in patients undergoing elective coronary artery bypass graft (CABG) and/or cardiac valve surgery.
The study yielded positive final results, meeting the primary biomarker endpoint as well as several key clinical outcome endpoints. These findings provide strong support for the advancement of RBT-1 into a pivotal Phase 3 study.
RBT-1 has been granted Breakthrough Therapy designation status by the U.S. Food and Drug Administration (FDA) specifically for reducing the risk of complications in patients undergoing cardiothoracic surgery.
