Renibus Therapeutics to Present on RBT-1 at 38th EACTS Annual Meeting

Renibus Therapeutics®, a clinical-stage biopharmaceutical company focused on the prevention and treatment of cardiac, renal, and metabolic diseases, announced an important oral presentation on its drug RBT-1 at the 38th EACTS Annual Meeting. This meeting is being held from October 9-12, 2024, in Lisbon, Portugal. The presentation will be delivered by Charles Mack, MD, FACS, who is an Associate Professor of Cardiothoracic Surgery and Vice Chairman of Quality and Patient Safety at New York-Presbyterian Hospital, Weill Cornell Medicine.

RBT-1 is a preconditioning agent given intravenously 24-48 hours before patients undergo non-emergency cardiac or valve surgery. Renibus is currently enrolling patients for a Phase 3 pivotal trial to evaluate the effectiveness of RBT-1 in reducing post-operative complications and improving patient outcomes after cardiac surgery. The drug has received Breakthrough and Fast Track Designations from the US FDA, indicating its potential to offer significant improvements over existing therapies.

Jeffrey Keyser, RPh, JD, PhD, President and CEO of Renibus, expressed enthusiasm about the recognition by EACTS. He noted that the enrollment for the Phase 3 PROTECT study is progressing ahead of schedule and anticipates reporting top-line data by the second quarter of 2025.

Charles A. Mack, MD, FACS, emphasized the promising results from the Phase 2 multi-center, randomized, double-blind, placebo-controlled study. He is excited to present new data from a post-hoc analysis, which included all patients irrespective of surgery delays, showing sustained improvements in clinical outcomes with RBT-1 treatment.

The oral presentation at the EACTS Annual Meeting will cover the effects of RBT-1 on clinical outcomes within the safety population of a Phase 2 study in cardiac surgery. The presentation is scheduled for October 11, 2024, at 9:15 am. The authors of the study include C. Mack (New York, USA), M. Jessen (Dallas, USA), A. Shaw (Cleveland, USA), S. Ruiz (Southlake, USA), C. Wang (Piscataway, USA), S. Snapinn (Seattle, USA), B. Singh (Southlake, USA), and A. Lamy (Ontario, Canada).

RBT-1, comprised of stannic protoporphyrin and iron sucrose, is designed to induce anti-inflammatory and antioxidant pathways. It is currently in Phase 3 trials for its primary indication to mitigate post-operative complications following cardiothoracic surgery. Having completed a Phase 2 study in February 2023, Renibus announced positive results in May 2023, and initiated the Phase 3 PROTECT study in October 2023.

Renibus Therapeutics is dedicated to developing products that prevent disease progression, improve outcomes, and protect against organ damage associated with cardiac, renal, and metabolic diseases. The company's lead program, RBT-1, is a single-dose intravenous drug meant to be administered 24-48 hours before elective cardiac or valve surgeries to reduce post-operative complications and enhance recovery. The drug has received both Breakthrough and Fast Track Designations from the FDA.

In addition to RBT-1, Renibus is also working on veverimer, an oral, non-absorbed hydrochloric acid binder acquired from Tricida. They are evaluating veverimer in preclinical models and reviewing historical data to identify suitable clinical trial indications. Renibus has three other assets in earlier stages of development.