Renibus Therapeutics Presents Interim Phase 2 Data:
RBT-1 Improves Post-Operative Outcomes in Cardiac Surgery Patients During Oral Session at AHA Scientific Sessions 2022

-RBT-1 interim results from a randomized double-blind placebo-controlled study showed statistically significant reductions in days on ventilator and days in ICU. 30-day hospital readmission was reduced by greater than 90% -(<0.0027)-

-RBT-1 was recently granted Fast Track Designation from U.S. FDA-

-Pivotal Phase 3 study of RBT-1 to be initiated in early 2023-

SOUTHLAKE, Texas, Nov. 7, 2022 /PRNewswire/ — Renibus Therapeutics, Inc., (“Renibus”), a clinical-stage biotechnology company developing breakthrough products for cardiorenal diseases, today announced that interim Phase 2 data for RBT-1 (stannous protoporphyrin/iron sucrose) were presented during an oral session at the American Heart Association (AHA) Scientific Sessions 2022 meeting, being held November 5-7, 2022, in Chicago, Illinois. Renibus also announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for RBT-1.

“Our oral presentation at AHA Scientific Sessions reflects the promising clinical data we have generated with RBT-1, demonstrating its utility as a preconditioning agent to reduce the risk of multiorgan damage that may improve post-operative outcomes in patients undergoing cardiothoracic surgery,” said Frank Stonebanks, Chairman and CEO of Renibus Therapeutics. “Our recent Fast Track designation from the U.S. FDA will enable us to rapidly advance RBT-1 into a pivotal Phase 3 study, which we expect to initiate in early 2023.”

The interim Phase 2 data suggests that RBT-1 improves outcomes and reduces the risk of post operative complications in patients undergoing elective cardiac bypass surgery. The Phase 2 study (NCT04564833) is a randomized, multi-center, placebo-controlled trial evaluating the effect of RBT-1 in patients undergoing coronary artery bypass graft (CABG) and/or cardiac valve surgery. The prospective interim analysis included 60 patients randomized to receive active drug (2 dose groups) or placebo. Renibus previously announced interim results from the RBT-1 Phase 2 study in June 2022.

“RBT-1 goes beyond protecting the kidneys. With its unique mechanism of action, RBT-1 has the potential for multiorgan preconditioning and has demonstrated remarkable interim results in Phase 2. In addition, RBT-1 improved overall patient outcomes in the interim analysis from this study, including reduced days on a ventilator, reduced days in ICU, and a substantial reduction in the 30-day hospital readmission rate. I look forward to working with Renibus in the upcoming Phase 3 registration study to bring this potentially transformative medicine to patients in need,” added Andre Lamy, MD, MSc, Cardiac Surgeon, Population Health Research Institute, McMaster University, Canada, Principal Investigator presenting on behalf of the START Investigators and Renibus.

 AHA Oral Presentation Details:

  • Title: “Interim Results of a Phase 2 Study With RBT-1 Evaluating Postoperative Course in Patients Undergoing Elective CABG/Valve Surgery on Cardiopulmonary Bypass“
  • Speaker: Andre Lamy, MD, MSc, Cardiac Surgeon, Population Health Research Institute, McMaster University, Canada, Principal Investigator presenting on behalf of the START Investigators and Renibus
  • Date/Time: Sunday, November 6, 2022, 9:30 am – 10:30 am
  • Session Type/Number/Title: Featured Science, FS.02, New Insights – Cardiac Surgery

Slides from the oral presentation at AHA Scientific Sessions will be available on the Renibus website under the publications section.

About RBT-1
RBT-1, a first-in-class product, works via induction of antioxidant (Nrf2), anti-inflammatory (IL-10) and iron metabolism (ferritin, hepcidin) pathways which are involved in organ injury. It is currently in Phase 2 development in cardiac surgery, and about to enter a Phase 3 registration study for its lead indication to reduce the risk of postoperative complications following cardiothoracic surgery. Pre-clinical and Phase I development is complete.  The Phase 2 study is a double-blind, randomized, placebo-controlled study to evaluate the effect of RBT-1 on preconditioning response biomarkers in subjects undergoing coronary artery bypass graft (CABG) and/or cardiac valve surgery (The START Study). A pre-specified interim analysis was conducted following enrollment of the first 60 patients, yielding statistically significant results in both the primary and several secondary clinical benefit endpoints. Final data will be available in December 2022.

RBT-1 is protected by composition of matter and other patents in multiple jurisdictions, which include the United States, Australia, China, Europe, Israel and Japan. RBT-1 has been granted Fast Track Designation from the U.S. Food and Drug Administration (FDA).

About Fast Track Designation
Fast Track designation is designed to facilitate development and expedite the review of therapies with the potential to treat serious or life-threatening conditions and fill an unmet medical need. Investigational products that receive Fast Track designation may benefit from early and frequent communication with the FDA and are eligible for rolling submission and review of the marketing application. Additionally, this designation provides potential pathways for accelerated regulatory approval.

About Renibus
Renibus is a clinical stage biopharmaceutical company dedicated to treating, improving and extending patients’ lives by developing breakthrough products to prevent disease progression, improve outcomes and protect against organ damage in cardiorenal diseases. 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, RBT-1 (SnPP / FeS), is a potent inducer of Nrf2, IL-10, and ferritin. RBT-1 is currently in Phase 2 development in cardiac surgery and will soon enter a Phase 3 registration study for its lead indication to reduce the risk of postoperative complications following cardiothoracic surgery. RBT-2 (tetrahydrocurmin) is an antioxidant and anti-fibrotic drug that has been shown to reduce the risk of CKD progression in preclinical models and will be in IND enabling and clinical development in 2023. RBT-3 (FeS), a novel, low molecular weight iron nanoparticle, is one component of RBT-1 and is targeted at reducing the risk of cisplatin-induced nephrotoxicity and will be in clinical development in 2023. RBT-9 (SnPP), a potent anti-inflammatory and antioxidant drug with anti-viral properties, is one component of RBT-1. It has been investigated in a 42-patient Phase 2 RCT in COVID pneumonia as a monotherapy in hospitalized patients. RBT-9 reduced hospital length of stay by ~70%. Additional pre-clinical work is underway in NASH progression 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.

Investor and Media Contact:
Amy Conrad
Juniper Point
amy@juniper-point.com
858-914-1962

Business Development Contact
Frank Stonebanks
Chairman and CEO, Renibus
fstonebanks@renibus.com