Renibus Therapeutics has announced the completion of patient enrollment in its pivotal Phase 3 PROTECT trial, evaluating RBT-1 for reducing post-operative complications in cardiac surgery patients. The trial successfully enrolled 423 patients across 40 clinical sites in the United States and Canada, exceeding its target of 400 participants.
RBT-1 (stannic protoporfin/iron sucrose) is a single-dose, first-in-class preconditioning agent administered intravenously 24-48 hours prior to non-emergent cardiac surgery. The therapy aims to induce anti-inflammatory and antioxidant pathways to protect against surgical complications.
Donald Jeffrey Keyser, R.Ph., J.D., Ph.D., President and CEO of Renibus, expressed enthusiasm about the milestone: "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. We believe that RBT-1 has the potential to transform the treatment landscape of cardiac surgery by reducing the risk of post-surgical complications."
Addressing a Significant Unmet Need
Approximately 250,000 cardiac surgeries are performed annually in the United States, with nearly two-thirds of patients experiencing post-operative complications that impact long-term outcomes and increase healthcare costs. Currently, no pharmacological therapies are approved specifically to reduce these risks.
Dr. Marc Gerdisch, Chief of Cardiothoracic Surgery at Franciscan Health Indianapolis, highlighted the significance of the rapid enrollment: "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."
If approved, RBT-1 would become the first and only pharmacological therapy on the market specifically designed to reduce post-operative complications following cardiac surgery.
Trial Design and Endpoints
The PROTECT trial is a randomized, double-blind, placebo-controlled study that began enrolling patients in October 2023. The primary endpoint is a composite measure that includes mortality, acute kidney injury requiring dialysis, intensive care unit days, and 30-day cardiopulmonary readmission rates, assessed based on severity using the Win-Ratio Method.
Secondary and exploratory endpoints include duration of ventilator use, requirement for blood products, incidence of new atrial fibrillation, hospital length of stay, cost-effectiveness analyses, and safety evaluations.
Dr. Ashish Khanna, Professor and Vice Chair of Research in the Department of Anesthesiology at Wake Forest School of Medicine, emphasized the potential economic impact: "As critical care physicians, we are focused on reducing the cost of patient services and lowering the economic burden on the healthcare ecosystem. I am excited about the potential for RBT-1 to improve patient outcomes and reduce healthcare costs."
Previous Clinical Success
RBT-1 has already demonstrated promise in earlier clinical development. Renibus completed a Phase 2 trial in February 2023 and announced positive results in May 2023, which supported advancement to the current Phase 3 study.
The therapy has received both Breakthrough Therapy and Fast Track Designations from the FDA's Division of Cardiology and Nephrology, highlighting its potential to address a serious condition and fill an unmet medical need.
Looking Forward
Topline results from the PROTECT trial are anticipated in the third quarter of 2025. Bhupinder Singh, M.D., F.A.S.N., F.N.K.F., Chief Medical Officer at Renibus, expressed gratitude to trial participants: "On behalf of Renibus and the clinical study team, I would like to thank the patients and study investigators who supported this important study."
Renibus Therapeutics focuses on developing products for preventing disease progression and protecting against organ damage in renal, metabolic, and cardiovascular conditions. In addition to RBT-1, the company has acquired veverimer, a late-stage clinical asset currently under preclinical evaluation and historical data analysis.
