RBT-1 (stannic protoporfin / iron sucrose) is a single dose, multi-organ, preconditioning agent that is administered intravenously 24-48 hours prior to patients undergoing elective cardiac surgery. RBT-1 is actively enrolling in a Phase 3 pivotal trial to reduce the risk of post operative complications and improve outcomes following cardiothoracic surgery. RBT-1 has received FDA Breakthrough and Fast Track Designations.
"Presenting at EACTS enables Renibus to share our promising RBT-1 results with the global cardiothoracic surgery community," stated Jeffrey Keyser, RPh, JD, PhD, President and CEO of Renibus. "In a completed Phase 2 clinical trial, RBT-1 demonstrated the potential to improve outcomes in the post-cardiac surgery setting, including reductions in 30-day hospital readmission rates, time in the ICU, as well as time on ventilator. We continue to advance RBT-1 through the Phase 3 PROTECT study, with top-line data expected in the third quarter of 2025."
Charles A. Mack, MD, FACS, Associate Professor of Cardiothoracic Surgery, New York-Presbyterian Hospital, Weill Cornell Medicine, added, "RBT-1 is an exciting pre-conditioning agent and I am honored to showcase its results at EACTS. While RBT-1 has demonstrated its potential benefit across multiple cardiac surgery types in its Phase 2 clinical trial, I look forward to presenting data demonstrating RBT-1's potential to have a greater impact on patients undergoing more complex procedures combining both CABG and valve surgeries where the risk of post-operative complications is greatest."
About RBT-1:
RBT-1 (stannic protoporfin/iron sucrose) is a potent inducer of anti-inflammatory and antioxidant pathways currently in Phase 3 [NCT # 06021457] for its lead indication to reduce post-operative complications following cardiothoracic surgery. Renibus completed the Phase 2 study of RBT-1 (NCT04564833) in February 2023 and announced positive final results from this study in May 2023. In October 2023, Renibus initiated enrollment and administration of RBT-1 in its PROTECT Phase 3 pivotal study.
RBT-1 was granted Breakthrough Therapy designation status from the U.S. FDA to reduce the risk of complications in patients undergoing cardiothoracic surgery.
About Renibus Therapeutics:
Renibus is a clinical stage biopharmaceutical company dedicated to treating, improving, and extending patients' lives by developing products to prevent disease progression, improve outcomes and protect against organ damage associated with cardio, renal and metabolic diseases. Renibus' first-in-a-new class lead program is RBT-1 (stannic protoporfin / iron sucrose), a single dose IV drug that is given over 1-2 hours, 24-48 hours prior to patients undergoing elective cardiac and/or valve surgery. It is in a Phase 3 pivotal trial to reduce the risk of post operative complications and improve outcomes following cardiothoracic surgery. The drug has received FDA Breakthrough and Fast Track Designations.
Veverimer is an oral, non-absorbed hydrochloric acid binder that was acquired from Tricida. We are currently evaluating veverimer in preclinical models and analyzing historical data to further our understanding of its clinical profile with a goal of identifying an indication for evaluation in clinical trials. Renibus has three additional assets at earlier stages of development.
For more information, please visit www.Renibus.com
