-Proceeds to fund pivotal Phase 3 trial of RBT-1, expected to initiate in Q4 2023-
-Phase 3 trial is designed as a standalone pivotal study to support a New Drug Application (NDA)-
SOUTHLAKE, Texas, September 12, 2023 (PR NEWSWIRE) – Renibus Therapeutics, Inc., (“Renibus”), a clinical-stage biopharmaceutical company focusing on the prevention and treatment of cardio-renal and metabolic diseases, today announced the close of an extension to its Series B financing round, bringing the total amount raised to $72 million. Renibus’ investors are comprised of existing and new investors, including leaders in the cardiac surgery community.
“Closing an upsized round with $72 million in demand is a testament to the experience and track record of the Renibus team and the unique potential of RBT-1 to act as a preconditioning agent, bringing long-overdue innovation to patients undergoing cardiac surgery,” said Frank Stonebanks, Co-CEO of Renibus. “We remain highly encouraged by our opportunity with RBT-1 and are well positioned to execute our pivotal Phase 3 development plans. In addition, the FDA’s alignment on our Phase 3 pivotal study and our recent Breakthrough Therapy Designation, give us great confidence to advance RBT-1 towards patients in need with the potential to create a transformative new drug category.”
Proceeds from the Series B financing will be used to advance RBT-1 through a pivotal Phase 3 trial for its lead indication of reducing the risk of post-operative complications following cardiothoracic surgery. RBT-1 (stannic protoporfin/iron sucrose) is a potent inducer of anti-inflammatory, antioxidant and iron scavenging pathways that acts as a preconditioning agent, initially being studied in cardiac surgery patients. In February 2023, Renibus completed Phase 2 development of RBT-1, and presented the data at the American Association for Thoracic Surgery Meeting during a late-breaking session in May 2023.
Jamie A. Donadio, Chief Financial Officer of Renibus, added, “We are pleased with the tremendous enthusiasm and commitment from our investors in deploying this additional capital. The funding provides sufficient runway to advance RBT-1 through the planned Phase 3 trial and preparation for an NDA filing. The upsized round is also expected to enable us to selectively fund additional pipeline programs with the potential for further value creation.”
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 and metabolic diseases. Renibus’ first-in-class lead program is RBT-1, a drug that will enter a Phase 3 pivotal trial in cardiothoracic surgery in Q4 2023. RBT-3 is a novel, low molecular weight iron nanoparticle that has the potential to rapidly resolve iron deficiency and may 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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