Southlake, Texas, October 3, 2024, (PR NEWSWIRE) – Renibus Therapeutics® (“Renibus”), a clinical-stage biopharmaceutical company focusing on the prevention and treatment of cardio, renal and metabolic diseases, today announced poster presentations of promising data results on its first-in-class Phase 3 program, RBT-1, at the AMCP Nexus 2024 Meeting, taking place October 14-17, 2024 in Las Vegas, NV.

RBT-1 is a single dose preconditioning agent that is administered intravenously 24-48 hours prior to patients undergoing elective cardiac and/or valve 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 Breakthrough and Fast Track Designations from the U.S. FDA.

“Presenting at AMCP Nexus 2024 enables Renibus to share our promising RBT-1 results with the cardiothoracic and managed care communities,” stated Jeffrey Keyser, RPh, JD, PhD, President and CEO of Renibus. “From the completed Phase 2 clinical trial, RBT-1 demonstrated the potential to reduce post-operative complications for patients and significantly lower healthcare costs in cardiac surgery patients, including those undergoing CABG and valve procedures. The data showed cost reductions of up to 30% and fewer complications, such as prolonged ICU stay, new-onset atrial fibrillation and 30 day readmissions. We are excited by these results and will continue to advance RBT-1 through the ongoing Phase 3 PROTECT study, with top-line data expected in the second quarter of 2025.”

Details of the poster presentations at AMCP Nexus 2024:

Title: Impact of RBT-1 on post-operative complications rates and costs for cardiac surgery

Abstract ID: 1855045

Date and Time: Wednesday, October 16, from 11:30am-2:30pm

Authors: Frans van Wagenberg, MS, MD, Lynn Cherry, PhD, Bhupinder Singh, MD, Stacey Ruiz, PhD, Raf Magar, MBA

Title: Impact of RBT-1 a novel treatment to reduce post-operative complication rates and costs for coronary artery bypass graft (CABG) surgery

Abstract ID: 1855213

Date and Time: Wednesday, October 16, from 11:30am-2:30pm

Authors: Frans van Wagenberg, MS, MD, Lynn Cherry, PhD, Bhupinder Singh, MD, Stacey Ruiz, PhD, Raf Magar, MBA

About RBT-1

RBT-1 (stannic protoporfin/iron sucrose) is a potent inducer of anti-inflammatory andantioxidant  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 the Company’s website at www.Renibus.com and engage with us on LinkedIn.