Renibus Therapeutics Announces Completion of Enrollment in PROTECT, a Pivotal Phase 3 Clinical Trial of RBT-1 to Reduce the Risk of Post-Operative Complications After Cardiac Surgery

- Topline results expected in Q3 2025 -     

SOUTHLAKE, Texas, April 24, 2025 /PRNewswire/ -- Renibus Therapeutics^® ("Renibus"), a clinical late-stage biopharmaceutical company focusing on the prevention and treatment of cardiac, renal, and metabolic diseases, today announced the completion of enrollment (n=400) in PROTECT, a pivotal Phase 3 trial evaluating the effect of RBT-1 on reducing the risk of post-operative complications in patients undergoing cardiac surgery (NCT06021457). The trial enrolled 423 patients across 40 trial sites in the United States (US) and Canada. Topline results from the study are anticipated in third quarter of this year.

RBT-1 (stannic protoporfin/iron sucrose) is a single-dose, first-in-class, preconditioning agent that is administered intravenously 24-48 hours prior to patients undergoing non-emergent cardiac surgery. Renibus previously completed a Phase 2 trial of RBT–1 (NCT04564833) in February 2023 and announced positive results from this trial in May 2023. RBT-1 has received Breakthrough Therapy and Fast Track Designations from the FDA.

"The achievement of full enrollment in the PROTECT trial is a major milestone for Renibus, and I couldn't be more grateful for the dedication of our Renibus team who accomplished this goal ahead of schedule," stated Donald Jeffrey Keyser, R.Ph., J.D., Ph.D., President and CEO of Renibus. "We believe that RBT-1 has the potential to transform the treatment landscape of cardiac surgery by reducing the risk of post-surgical complications."

"On behalf of Renibus and the clinical study team, I would like to thank the patients and study investigators who supported this important study," stated Renibus' Chief Medical Officer, Bhupinder Singh, M.D., F.A.S.N., F.N.K.F.

Dr. Marc Gerdisch, Chief of Cardiothoracic Surgery at Franciscan Health Indianapolis added, "RBT-1 has shown great potential in clinical studies to reduce serious complications that arise following cardiac surgery. I am encouraged that PROTECT enrolled so quickly, which underscores the large unmet medical need to prevent complications following the entire spectrum of heart surgeries. Soon we will better understand the promise of improved outcomes RBT-1 may provide our patients."

The lack of drug therapies targeting the reduction in risk of post-operative complications following cardiac surgery represents a significant unmet medical need. In the United States, there are approximately 250,000 cardiac surgeries, with approximately two thirds of patients having post-operative complications that impact long-term outcomes and drives increased cost to the healthcare system. RBT-1, if approved, would be the first and only pharmacological therapy on the market to reduce the risk of post-operative complications following cardiac surgery.

"As critical care physicians, we are focused on reducing the cost of patient services and lowering the economic burden on the healthcare ecosystem. In treating cardiothoracic surgical patients, almost two-thirds of patients will have complications following surgery which leads to further hospitalizations, increased time in the ICU, and longer-term health concerns," said Ashish Khanna M.D., F.C.C.P., F.C.C.M., Professor, Vice Chair of Research Department of Anesthesiology, Section on Critical Care Medicine, Wake Forest School of Medicine, Atrium Health Wake Forest Baptist Medical. "I am excited about the potential for RBT-1 to improve patient outcomes and reduce healthcare costs."

About RBT-1

RBT-1 is a potent inducer of anti-inflammatory and antioxidant pathways and is currently being evaluated to reduce post-operative complications following cardiac surgery (NCT06021457). Previously, Renibus completed the Phase 2 trial of RBT-1 (NCT04564833) in February 2023 and announced positive final results from this trial in May 2023. In October 2023, Renibus initiated enrollment and administration of RBT-1 in its PROTECT Phase 3 pivotal trial and announced completion of enrollment in April 2025.

RBT-1 has been granted Breakthrough Therapy and Fast Track Designations by the Division of Cardiology and Nephrology at the FDA.

About PROTECT

PROTECT is a Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of RBT-1 on Reducing the Risk of Post-Operative Complications in Subjects Undergoing Cardiac Surgery. The primary endpoint of this pivotal phase 3 study is a composite of death, AKI requiring dialysis, ICU days, and 30-day cardiopulmonary readmission rates, evaluated based upon severity, using the Win-Ratio Method. Secondary and exploratory objectives include time on the ventilator, need for blood products, new onset atrial fibrillation, hospital length of stay, cost effective analyses and safety. 

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' lead first-in-class combination drug therapy is RBT-1, a single dose IV drug that is given over 1-2 hours, 24-48 hours prior to patients undergoing elective cardiac surgery. RBT-1 has just completed a Phase 3 pivotal trial (called PROTECT) measuring its primary objective to reduce the risk of post operative complications and improve outcomes following cardiac surgery.

Renibus acquired veverimer, a late-stage clinical asset. Veverimer is an oral, non-absorbed hydrochloric acid binder. Renibus is 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.

For more information, please visit the Company's website at www.Renibus.com 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