Renibus announced that data from the Phase 3 PROTECT trial of RBT-1 will be presented orally at the American Association for Thoracic Surgery annual meeting in Chicago on 4 May 2026.
The randomized, double-blind, placebo-controlled trial enrolled 433 patients across 34 sites in the United States and Canada to assess whether a single infusion of RBT-1, given 24 to 48 hours before non-emergent cardiac surgery, could reduce postoperative complications through postoperative day 60.
According to the company, the study did not meet its primary endpoint, a hierarchical composite win ratio of death, dialysis-requiring acute kidney injury, 30-day cardiopulmonary readmission, and ICU days (WR 0.87 [0.66, 1.15], p=0.33), and key secondary endpoints were not statistically significant.
The study population was predominantly low-risk, with about 70 percent having an STS predicted operative mortality below 2 percent.
The company claims post-hoc analyses suggest potential benefit in higher-risk subgroups, including patients with chronic kidney disease and higher STS risk scores. RBT-1 was generally safe and well-tolerated, with photosensitivity and transient infusion-related reactions as the most common treatment-related adverse events. Renibus said it will further evaluate the data to define next steps in development.
