Renibus Therapeutics, a US-based clinical-stage biopharmaceutical company, announced on Wednesday that it has dosed its first patient in the pivotal Phase three PROTECT trial of RBT-1, the company's first-in-a-new-class preconditioning agent, under investigation to reduce post-operative complications following cardiothoracic surgery.

PROTECT is expected to be carried out at around 35 sites in the United States and Canada. It is a phase three randomised, double blind, placebo-controlled study to assess the impact of RBT-1 on Reducing the Risk of Post-Operative Complications in Subjects Undergoing Cardiac Surgery.

RBT-1 (stannic protoporfin/iron sucrose), a fixed dose combination product, is administered once intravenously over one to two hours, 24-48 hours prior to surgery. It is claimed to be a potent inducer of anti-inflammatory, antioxidant and iron-scavenging pathways. In a completed Phase two study, RBT-1 demonstrated statistically significant positive data in primary and several secondary endpoints, with reduced time in the ICU, reduced patient recovery time and fewer hospital readmissions.

The study, a randomised, double-blind, multi-centre, placebo-controlled trial, is assessing the impact of RBT-1 in around 400 subjects.