Stannous protoporphyrin

- Renibus recently completed enrollment in a Phase 3 pivotal trial PROTECT to reduce the risk of post-operative complications and improve outcomes following cardiac surgery - SOUTHLAKE, Texas, April 25, 2025 /PRNewswire/ -- Renibus Therapeutics® ("Renibus"), a clinical-stage biopharmaceutical company focusing on the prevention and treatment of cardiac, renal, and metabolic diseases, today announced that a poster presentation will be delivered on RBT-1 at the 47th Annual Meeting of the Society of Cardiovascular Anesthesiologists (SCA), taking place April 26-29, 2025 in Montreal. RBT-1 is a single-dose, first-in-class, preconditioning agent that is administered intravenously 24-48 hours prior to patients undergoing non-emergent cardiac and/or valve surgery. Renibus previously completed a Phase 2 study of RBT-1 (NCT04564833) in February 2023, announced positive final results from this study in May 2023, and has recently completed enrollment in its Phase 3 PROTECT study. RBT-1 has received Breakthrough and Fast Track Designations from the US FDA. "We are excited to build on our recent momentum of achieving full enrollment in our Phase 3 PROTECT study with a poster presentation at SCA 2025 that we can share with the global anesthesiologist community," stated Jeffrey Keyser, RPh, JD, PhD, President and CEO of Renibus. "Our poster highlights the complicated economic impact of post-operative complications and increasing costs for CABG and value surgery to the healthcare system, which directly affects anesthesiologists. With the use of RBT-1 in our Phase 2 study, we reduced the complication rates from cardiovascular surgery, and in turn, the overall healthcare costs. We look forward to continuing to demonstrate these encouraging results in Phase 3." Frans van Wagenberg, MD, Huntsville Heart Center, Huntsville, Alabama, commented, "I am pleased to present results of a cost-analysis based on a Phase 2 trial which suggest that RBT-1 has a protective effect, leading to lower complication rates and reduced average expected costs overall. Additional data from an ongoing Phase 3 trial, which includes a 1-year post-discharge follow-up, will further evaluate the impact of RBT-1 on clinical, economic, and qualitative outcomes compared to standard care." Details of the poster presentation at SCA 2025: Title: "Clinical and Economic Impact of RBT-1 on Post-operative Complications and Costs for CABG and Valve Surgery" Date and Time: Sunday, April 27, 2025 at 12:30 Authors: Frans van Wagenberg, MD, Lynn Cherry, PhD, Bhupinder Singh, MD, Stacey Ruiz, PhDc, Raf Magar MB About RBT-1 RBT-1 (stannic protoporfin/iron sucrose) is a potent inducer of anti-inflammatory andantioxidant pathways currently being evaluated in the Phase 3 PROTECT study for its lead indication to reduce post-operative complications following cardiothoracic surgery. Previously, 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 and announced completion of enrollment in April 2025. 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 (called PROTECT) 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. The drug has received FDA Orphan Drug Designation. 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 and engage with us on LinkedIn. Investor and Media Contact: Amy Conrad Juniper Point [email protected] 858-914-1962 Business Development Contact Jamie Donadio CFO, Renibus [email protected] SOURCE Renibus Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED