Renibus Therapeutics Completes Enrollment in Pivotal RBT-1 Trial for Cardiac Surgery

Renibus Therapeutics Completes Enrollment in Pivotal PROTECT Trial for RBT-1

On April 24, 2025, Renibus Therapeutics announced that it has successfully completed enrollment in its pivotal Phase 3 clinical trial known as PROTECT, aimed at assessing the effectiveness of RBT-1 in minimizing post-operative complications following cardiac surgery. This significant milestone puts the company on track to deliver important findings, with topline results anticipated in the third quarter of 2025.

The PROTECT trial enrolled 423 patients across 40 different sites in both the United States and Canada. This trial is a randomized, double-blind, placebo-controlled study designed to evaluate RBT-1's potential benefits specifically in reducing the risk of complications for those undergoing cardiac surgical procedures. The rapid enrollment phase underscores an urgent need in the medical community; many patients face various post-surgical complications that adversely affect their recovery and overall healthcare costs.

RBT-1—a first-in-class medication—functions by preconditioning the patient’s body to enhance recovery outcomes. Administered intravenously 24 to 48 hours ahead of non-emergent cardiac surgeries, this innovative, single-dose treatment aims to mitigate risks such as acute kidney injury (AKI), prolonged ICU stays, and other serious post-operative issues.

According to Donald Jeffrey Keyser, President and CEO of Renibus, the completion of enrollment is a major achievement and reflects the hard work and dedication of their team. He emphasized the transformative potential of RBT-1 within the cardiac surgery landscape, hoping to significantly lower surgical risks.

The clinical community echoes this optimism. Dr. Bhupinder Singh, Chief Medical Officer of Renibus, expressed gratitude to patients and study investigators for their participation, stressing the importance of the study in addressing the high unmet medical need for post-operative care in cardiac surgery. Dr. Marc Gerdisch, Chief of Cardiothoracic Surgery at Franciscan Health Indianapolis, highlighted how previous studies have showcased RBT-1’s potential to prevent critical complications related to heart surgeries.

Accurate statistics reveal the gravity of the situation: approximately 250,000 cardiac surgeries occur each year in the U.S., with two-thirds of the patients experiencing post-operational complications. This poses a significant burden not only on individual health but also on the healthcare infrastructure at large.

Dr. Ashish Khanna, a professor specializing in anesthesiology, emphasized the economic implications of these complications. With nearly 66% of cardiac surgery patients facing challenges post-surgery, including increased hospital stays and healthcare costs, RBT-1 could offer a much-needed solution, aiming to enhance patient recovery and decrease the overall financial load on health systems.

The RBT-1 molecule operates on innovative mechanisms, promoting anti-inflammatory and antioxidant pathways critical for patient recovery. As the Phase 3 trial unfolds, its primary objectives focus on evaluating a composite outcome including mortality rates, the incidence of AKI that necessitates dialysis, and other relevant metrics.

In summary, the PROTECT trial marks a pivotal moment in cardiac treatment advancements. Should RBT-1 receive FDA approval following trial completion, it would stand as the first pharmacological option designed to directly address the underlying complications associated with cardiac surgeries. The anticipation for positive results is high, and both the medical community and prospective patients await the new developments from Renibus Therapeutics with optimistic hope.

For further updates and insights, visit Renibus Therapeutics’ website or follow their official communications.