Renibus Therapeutics Granted Breakthrough Therapy Designation by US FDA for RBT-1 in Reducing Post-Operative Complications in Cardiothoracic Surgery Patients.
Wednesday, July 12, 2023
Renibus Therapeutics, a clinical-stage biopharmaceutical company specializing in cardio-renal diseases, has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for their drug candidate RBT-1. The designation is specifically for reducing the risk of post-operative complications in patients undergoing cardiothoracic surgery, aligning with the company's planned Phase 3 pivotal trial.
The FDA's decision was based on positive Phase 2 clinical results presented at the American Association for Thoracic Surgery (AATS) meeting in May 2023. The study met the primary biomarker endpoint and demonstrated favorable clinical outcomes, suggesting the potential of RBT-1 to improve postoperative outcomes in cardiothoracic surgery. This designation is significant as RBT-1 is the first pharmacological pre-conditioning agent to receive Breakthrough Therapy status.
Frank Stonebanks, Co-CEO of Renibus, expressed the importance of this achievement for the company, highlighting their goal of establishing a new drug category. The FDA's Breakthrough Therapy designation expedites the development and review process for drugs intended to treat serious or life-threatening conditions when they show substantial improvement over existing therapies.
RBT-1, composed of stannic protoporfin/iron sucrose, possesses potent anti-inflammatory, antioxidant, and iron-scavenging properties. It is currently advancing towards Phase 3 development for its primary indication of reducing post-operative complications following cardiothoracic surgery.
In February 2023, the Phase 2 study of RBT-1 (NCT04564833) concluded. The study, a randomized, double-blind, multi-center, placebo-controlled trial, focused on patients undergoing elective coronary artery bypass graft (CABG) and/or cardiac valve surgery. Positive final results from the study, announced in May 2023, support the progression of RBT-1 into a pivotal Phase 3 trial.