Renibus Therapeutics, a US-based clinical late-stage biopharmaceutical company focusing on the prevention and treatment of cardiac, renal, and metabolic diseases, on Thursday announced the completion of enrolment (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 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.