Renibus Therapeutics has completed subject enrolment for the randomised Phase III PROTECT trial, assessing RBT-1 (stannic protoporfin/iron sucrose) in minimising post-operative complication risk in cardiac surgery patients.
The trial reached its enrolment target, with 423 patients across 40 sites in Canada and the US. Its topline outcomes are expected in the third quarter of 2025.
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RBT-1 is a preconditioning agent given intravenously before non-emergent cardiac surgery. It aims to induce anti-inflammatory and antioxidant pathways.
The placebo-controlled, double-blind trial commenced subject enrolment and administration of the therapy in October 2023.
Its primary endpoint is a composite measure, which 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 goals include the duration of ventilator use, requirement for blood products, incidence of new atrial fibrillation cases, and the duration of hospital stay, as well as expense efficiency and safety analyses.
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By GlobalDataThe therapy has previously shown promise in a Phase II trial completed in February 2023, with positive outcomes announced in May 2023.
Renibus Therapeutics CEO and president Donald Jeffrey Keyser said: “The achievement of full enrolment 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.”
Renibus Therapeutics develops products for preventing the progression of the disease and protecting against organ damage in renal, metabolic, and cardio conditions.
The company has also acquired the late-stage clinical asset veverimer, which is currently under preclinical evaluation and historical data analysis.
