– Agreement reached with FDA for Phase 3 pivotal trial for RBT-1 –
– RBT-1 is a first-in-class, pre-conditioning drug in the cardiothoracic surgery setting –
– Company to initiate pivotal Phase 3 study of RBT-1 in Q3 2023 –
SOUTHLAKE, Texas, July 11, 2023 /PRNewswire/ – Renibus Therapeutics, Inc., (“Renibus”), a clinical-stage biopharmaceutical company focusing on the prevention and treatment of cardio-renal diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to RBT-1 for the reduction in risk of post-operative complications in patients undergoing cardiothoracic surgery, and confirmed its alignment with the Company’s planned Phase 3 pivotal trial.
Breakthrough Therapy designation for RBT-1 was based on Phase 2 clinical results that were presented at the American Association for Thoracic Surgery (AATS) meeting in May 2023. The study achieved the primary biomarker endpoint, as well as several key clinical outcome endpoints, which supports the potential for RBT-1 to improve postoperative outcomes in cardiothoracic surgery.
“We are thrilled that the FDA granted Breakthrough Therapy designation for RBT-1, which represents the first pharmacological pre-conditioning agent that we are aware of to ever be given this designation. This is a significant achievement for Renibus that underscores our strategy to create a new drug category,” said Frank Stonebanks, Co-CEO of Renibus. “We are also pleased the FDA has communicated to us they are aligned with our Phase 3 pivotal study, which we plan to initiate very soon.”
The FDA’s Breakthrough Therapy designation is intended to expedite the development and review of a drug candidate that is planned for use to treat a serious or life-threatening disease or condition when clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.
RBT-1 (stannic protoporfin/iron sucrose) is a potent inducer of anti-inflammatory, antioxidant and iron-scavenging pathways that is advancing toward Phase 3 development for its lead indication to reduce post-operative complications following cardiothoracic surgery.
The Phase 2 study of RBT-1 (NCT04564833), which was completed in February 2023, was a randomized, double-blind, multi-center, placebo-controlled trial evaluating the effect of RBT-1 in patients undergoing elective coronary artery bypass graft (CABG) and/or cardiac valve surgery. Renibus announced positive final results from this study in May 2023, which supports the advancement of RBT-1 into a pivotal Phase 3 study.
In June 2023, RBT-1 was granted Breakthrough Therapy designation status from the U.S. FDA to reduce the risk of complications in patients undergoing cardiothoracic surgery.
In July 2023, Renibus reached agreement with the FDA on the Phase 3 program for RBT-1.
Renibus is a clinical stage biopharmaceutical company dedicated to treating, improving and extending patients’ lives by developing products to prevent disease progression, improve outcomes and protect against organ damage associated with cardiorenal diseases and complex surgeries. The Company has developed a robust portfolio of products that activate multiple cytoprotective pathways, including organ protection via preconditioning. Renibus’ first-in-class lead program is RBT-1. RBT-2 is an antioxidant and anti-fibrotic drug that has been shown in pre-clinical models to have the potential to reduce the risk of CKD progression. RBT-3 is a novel, low molecular weight iron nanoparticle that has the potential to rapidly resolve anemia and reduce the risk of cisplatin-induced nephrotoxicity. RBT-9 (stannic protoporfin) is a potent anti-inflammatory and antioxidant drug with broad spectrum anti-viral properties. It has been investigated in a 42-patient Phase 2, randomized, placebo-controlled trial in high-risk patients with COVID-19. The data from this trial indicated the RBT-9 has the potential to significantly improve clinical outcomes in life threatening viral infections. Additional pre-clinical work is underway to help inform the clinical development strategy.
For more information, please visit the Company’s website at www.Renibus.com and engage with us on LinkedIn.
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