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Rénibus Therapeutics®

Rénibus Therapeutics® Inc.

is a biotech company dedicated to transforming the cardio-renal disease treatment paradigm by focusing on the reducing the risk and treatment of kidney disease. 

This includes reducing the risk of post operative complications in patients undergoing cardiothoracic surgery which represents a significant unmet medical need and results in high morbidity, mortality, and costs to the healthcare system. 

  • 36% of patients experience major postoperative complications after cardiac surgery.

Intensive care after a cardiothoracic surgery is a standard component of the treatment for most of the patients. However, a long intensive care stay results in increased hospital mortality, poor long-term prognosis, increased morbidity, increased hospital days, and consequently, increased cost and expenses. 

  • Up to 36% of patients undergoing cardiac surgery have a long (> 36 hours) postoperative stay in intensive care unit. 
  • This results in failure of some organs, an increase in mortality rates as well as higher utilization of healthcare resources

Each year, 9 million U.S. adults suffer from acute kidney injury (AKI) and today, 37 million U.S. adults are living with chronic kidney disease (CKD). It is also associated with a higher risk of mortality in both inpatient and outpatient settings, and progression to CKD within 24 months occurs in approximately 15-20% of patients who survive AKI. 

The quality of life and financial burdens of AKI and CKD have reached insurmountable proportions for patients and their families. Unfortunately, there are currently no approved therapies that reduce the risk or treat AKI.

Read More About Our Pipeline

Rénibus’ lead product, RBT-1, is a novel pharmacologic intervention combining stannous protoporphyrin and iron sucrose, induces a preconditioning protective effect on the kidney and other organs, upregulating production of protective proteins to prevent post operative complications following cardiothoracic surgery, including AKI, days in the ICU, time on ventilator, and hospital readmission rates. Pre-clinical and Phase I development is complete, and RBT-1’s Phase II trial a Phase 2, 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) was initiated in April 2021 and is expected to be completed in Q4 2022. A pre-specified interim analysis was conducted following the enrollment of the first 60 patients, yielding statistically significant results in both the primary and several secondary endpoints (even though the study was not powered for this). 

An End of Phase 2 Meeting with the FDA will take place in Q3 2022 and Renibus is planning to start a Phase 3 registration study in Q4 2022.  

RBT-2 (Tetrahydrocurcumin) is an active metabolite of an antioxidant natural product that slows the progression of CKD by restoring cellular homeostasis and reducing inflammation and fibrosis development. Protective effects of RBT-2 have been observed in the heart. RBT-2: formulation and IND enabling work in progress. Phase I/II studies are expected to start in Q1 2023.

RBT-3 is a proprietary and differentiated form of iron sucrose that rapidly increases plasma ferritin and activates the body’s key cytoprotective pathway, Nrf2. It does so without inducing any signs of toxicity, as assessed both in healthy human subjects and patients with chronic kidney disease. In addition to Nrf2 activation, RBT-3 also increases plasma and tissue levels of hepcidin, a well-known cytoprotectant in animals. A Phase III development program looking at how RBT-3 limits the damage associated with cisplatin-induced nephrotoxicity is expected to begin in the 2H, 2022, using the 505b2 pathway.

Executive Management Team

Frank Stonebanks

Chairman and CEO

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D. Jeff Keyser, RPh, JD, PhD

President and Chief Operating Officer

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Bhupinder Singh, MD

Chief Medical Officer

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Jamie A. Donadio

Chief Financial Officer

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Board of Directors

Frank Stonebanks

Chairman

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D. Jeff Keyser, RPh, JD, PhD

Secretary and Director

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Henrik Rasmussen, MD, PhD

Director

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Bhupinder Singh, MD

Director

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Carlos Guillem, MBA, PhD

Director

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Al Guillem, PhD

Observer

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Scientific Advisors

Richard Zager, MD

Chairman

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Stuart Goldstein, MD, FAAP, FNKF

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Philip T. Lavin, PhD, FASA, FRAPS

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Jean-Claude Tardif, MD, FRCPC, FACC, FCAHS

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Patrick Murray, MD, MPH

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Navdeep Tangri, MD, PhD, FRCP(C)

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Laboratory of Basic and Translational Research

Seattle, WA

Richard A Zager, MD

SVP Translational Research

Ali C.M. Johnson, MS

Staff Scientist

Facts about

CT Surgery Post-Op Complications

Cardiothoracic surgery represents a significant burden to the US healthcare system with over 294,000 coronary artery bypass graft (CABG) and valve replacement/repair procedures performed annually. 

CABG the most common cardiothoracic surgical procedure in the US accounts for $6.5 billion in health care costs annually making it one of the most expensive surgical procedures in the United States. 

ICU is a standard component of postoperative care following cardiothoracic surgery however the longer the patient stays in ICU results in increased hospital morbidity and mortality, poor long-term prognosis, increased hospital stays, and consequently increased cost and expenses.  Most ICU therapies post cardiothoracic surgery are only supportive and therefore may not individually result in improved outcomes.

Cardiac surgery techniques have improved considerably however up to 36% of patients undergoing cardiothoracic surgery are still exposed to a high risk of postoperative complications.  

These postoperative complications include longer patient days in the intensive care unit (ICU), increase ventilator days, acute kidney injury and an increase in the 30-day hospital readmission rate.

  • More than 36% of patients undergoing cardiac surgery have a long (> 36 hours) postoperative stay in ICU. 
  • This results in failure of some organs and an increase in the mortality rate.

Failure to rescue (FTR) is defined as patient mortality after a post cardiothoracic surgery complication that occurred before hospital discharge. 

  • Early failure to rescue increases as the number of postoperative complications increased 7.5%, 28.1%, and 51.5% for one, two, and three or more complications, respectively. 
  • FTR rates were highest among those with combined prolonged ventilation and renal failure at 38.4%.
  • Length of intensive care unit stay varied by number of postoperative complications with the median number of intensive care unit hours ranging from 38 hours for patients with no complications to 358.5 hours for patients with at least three complications. 
  • Overall median length of stay ranged from 7 days for patients with no complications to 22.5 days for patients with at least three complications.

The average cost of CABG surgery without complications is approximately $36,580.

The additive cost effects of complications after cardiothoracic surgery are:

  • Prolonged ventilation (>24 h) +$33,840
  • Renal failure +$33,847
  • Reoperation +$35,239

Prolonged ventilation incurs the highest health system expenditures given its high incidence and the accumulation of multiple complications increase costs exponentially.

Facts about

Acute Kidney Injury (AKI)

Recognizing the need to improve treatment and health outcomes for patients with kidney disease, an Executive Order on Advancing American Kidney Health was issued in 2019 by the President of the United States. This initiative set forth policy with “a focus on delaying or preventing the onset of kidney failure, preventing unnecessary hospitalizations, and increasing the rate of transplants.” Preventing or reducing the severity of AKI is a critical step toward achieving these goals, especially as no such treatments are currently available. This unmet medical need is also highlighted by the fact that 15-20% of patients with AKI develop chronic kidney disease (CKD). Despite approximately 30 million adults in the US with CKD, there are no approved treatments to stop progression of this disease.

  • 20% of all hospitalized patients in developed countries develop AKI; this rate increases to 67% in the ICU setting
  • AKI severity is associated with a higher risk of mortality in both inpatient and outpatient settings
  • Annual death rate from AKI in the US is higher than breast cancer, lung cancer, diabetes, and heart failure combined
  • AKI confers a 9 times higher risk of CKD
  • AKI confers a 2 times higher risk of premature death
  • AKI contributes to incident CKD and accelerated progression of end-stage renal disease (ESRD)
  • Annual cost of AKI in the US is approximately $10 billion, representing a large economic health burden
  • One of the most expensive conditions in US hospitals, with a cost of ~$5 billion for 498,000 hospital stays in 2011
  • Most common complication of a number of surgical procedures, including coronary artery bypass grafting
CKD Overview

Chronic Kidney Disease (CKD)

  • 30 million people or approximately 15% of U.S. Adults have CKD. (CDC 2017)
  • Almost one out of every 7 adults 30-64 years of age is expected to develop CKD during their lifetime
  • While dialysis-dependent CKD accounts for only 0.5% of the U.S. population, fee-for-service expenditures for Medicare beneficiaries with dialysis-dependent CKD exceeded 30 billion dollars in 2013, or over 7% of the Medicare paid claims cost
  • Escalation in healthcare expenditures associated with CKD starts prior to the requirement for dialysis and treatment cost escalate as non-dialysis dependent CKD progresses
  • CKD is a significant unmet medical need, and the financial burden has reached insurmountable proportions for patients and the U.S. healthcare system. In 2018, Medicare costs were $119 billion, and similar public cost burdens likely exist in the EU and Asia.

Product Pipeline

RBT-1:  Stannous Protoporphyrin (SnPP) and Iron Sucrose (FeS)

Rénibus’ lead product, RBT-1, is a novel pharmacologic intervention combining stannous protoporphyrin and iron sucrose, induces a preconditioning protective effect on the kidney and other organs, upregulating production of protective proteins to prevent post operative complications following cardiothoracic surgery, including AKI, days in the ICU, time on ventilator, and hospital readmission rates. Pre-clinical and Phase I development is complete, and RBT-1’s Phase II trial a Phase 2, 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) was initiated in April 2021 and is expected to be completed in Q4 2022. A pre-specified interim analysis was conducted following the enrollment of the first 60 patients, yielding statistically significant results in both the primary and several secondary endpoints (even though the study was not powered for this).

An End of Phase 2 Meeting with the FDA will take place in Q3 2022 and Renibus is planning to start a Phase 3 registration study in Q4 2022.

RBT-2:
Tetrahydrocurcumin

RBT-2 (Tetrahydrocurcumin) is an active metabolite of an antioxidant natural product that slows the progression of CKD by restoring cellular homeostasis and reducing inflammation and fibrosis development. Protective effects of RBT-2 have been observed in the heart. RBT-2: formulation and IND enabling work in progress. Phase I/II studies are expected to start in Q1 2023.

RBT-3:  Iron
Sucrose (FeS)

RBT-3 is a proprietary and differentiated form of iron sucrose that rapidly increases plasma ferritin and activates the body’s key cytoprotective pathway, Nrf2. It does so without inducing any signs of toxicity, as assessed both in healthy human subjects and patients with chronic kidney disease. In addition to Nrf2 activation, RBT-3 also increases plasma and tissue levels of hepcidin, a well-known cytoprotectant in animals. A Phase III development program looking at how RBT-3 limits the damage associated with cisplatin-induced nephrotoxicity is expected to begin in the 2H, 2022, using the 505b2 pathway.

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Rénibus News

Renibus Therapeutics Announces Positive Interim Data from RBT-1 Phase 2 Trial

June 15th, 2022

Renibus Therapeutics Expands Leadership Team, Announces Appointments of New Chief Financial Officer and Chief Medical Officer

June 2nd, 2022

Renibus Therapeutics Strengthens IP Position with Additional US Patent

April 13th, 2022

Renibus Therapeutics Announces Appointment of Frank Stonebanks as CEO and $35 Million Series A Funding

February 15, 2022

Renibus Therapeutics Announces Presentations at the American Society of Nephrology Kidney Week 2021

October 28, 2021

Rénibus Therapeutics® Initiates Phase 2 Study of RBT-1 for Prevention of Acute Kidney Injury

March 11, 2021

Rénibus Therapeutics® to Present Phase 1b Data on RBT-1
at Acute Kidney Injury & Continuous Renal Replacement
Therapy 2021 Conference

February 25, 2021

Rénibus Therapeutics® Announces Publication of
Positive Results of RBT-3 Experimental Preclinical
Studies in Scientific Journal Nephrology Dialysis Transplant

February 16, 2021

Presentations at the American Society of Nephrology Kidney Week 2020

October 19, 2020

Renibus Therapeutics® Announces Abstract Presentation at the 2020 European Renal Association – European Dialysis and Transplant Association (ERA-EDTA) Annual Congress

June 9, 2020

A Pharmacologic “Stress Test” for Assessing Select Antioxidant Defenses in Patients with CKD,

Richard A. Zager, Ali C.M. Johnson, Alvaro Guillem, Jeff Keyser and Bhupinder Singh. CJASN April 2020, CJN.15951219; DOI: https://doi.org/10.2215/CJN.15951219

May, 2020

Parenteral Iron Sucrose-Induced Renal Preconditioning: Differential Ferritin Heavy and Light Chain Expression in Plasma, Urine and Internal Organs.

Johnson AC, Gooley T, Guillem A, Keyser J, Rasmussen H, Singh B, Zager RA. Am J Physiol Renal Physiol. 2019 Oct 14. doi: 10.1152/ajprenal.00307.2019. [Epub ahead of print] PMID: 31608670

December 1, 2019

Tin protoporphyrin activates the oxidant-dependent NRF2-cytoprotective pathway and mitigates acute kidney injury

Tin protoporphyrin (SnPP), a heme oxygenase (HO) inhibitor, can paradoxically protect against diverse forms of

August 01, 2017

Combined iron sucrose and protoporphyrin treatment protects against ischemic and toxin-mediated acute renal failure

Tissue preconditioning, whereby various short-term stressors initiate organ resistance to subsequent injury, is well...

March 23, 2016

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Rénibus Therapeutics® Inc.

181 Grand Ave,
Suite 225,
Southlake, TX 76092

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