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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 prevention, treatment, and diagnostic testing of kidney disease. 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). As the most common complication of a number of surgical procedures, AKI occurs in approximately 30% of patients undergoing cardiac surgery. It is 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 for prevention or treatment of AKI or to stop the progression of CKD leading to dialysis.  

Rénibus’ RTI’s lead product, RBT-1, is a novel pharmacologic intervention that induces preconditioning of the kidney, upregulating production of protective proteins to prevent AKI during cardiac surgery. Phase I development is completed, and a Phase II study is anticipated to begin in 1H, 2021. RBT-2 is an active metabolite of an antioxidant natural product that reduces CKD progression by restoring cellular homeostasis and reducing inflammation and fibrosis development. Protective effects of RBT-2 have also been observed in the heart. IND-enabling work with RBT-2 is currently in progress, and it is anticipated that a Phase I study will be conducted in 1H, 2022. RBT-3 is being developed to treat iron deficiency anemia. RBT-3 rapidly increases plasma ferritin without inducing nephrotoxicity or cardiotoxicty. Phase II development with RBT-3 is expected to be in 1H, 2022.

Due to the COVID-19 global health crisis, Rénibus is developing a novel antiviral therapy RBT-9 [Stannous protoporphyrin (SnPP)]  for the treatment of COVID-19 in patients with mild or moderate disease and at high risk for disease progression. RBT-9 reduces the viral load of several enveloped viruses and protects organs by mitigating viral-induced inflammation and upregulating the production of protective proteins. Therefore, via separate mechanisms, RBT-9 may benefit patients with COVID-19 by both inhibiting viral activity and preventing organ failure.

Rénibus has received a Fast Track designation from the FDA for RBT-9. The Phase II trial is now enrolling.

Executive Management Team

Al Guillem, PhD

Chief Executive Officer

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D. Jeff Keyser, RPh, JD, PhD

President and Chief Operating Officer

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Allan Avery

Chief Commercial Officer

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Fiona Stavros, Ph.D.

Sr. VP, Pre-Clinical Affairs

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Mark Nuttall

VP, Quality Assurance

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Stacey Ruiz, PhD

VP, Drug Development and Medical Affairs

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Board of Directors

Al Guillem, PhD

Chairman and Director

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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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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

Director

Ali C.M. Johnson, MS

Staff Scientist

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.
Facts about

Coronavirus 2019 (COVID-19)

  • A respiratory tract infection caused by a virus known as severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2)
  • First discovered in 2019, COVID-19 was declared a pandemic by the World Health Organization (WHO) on March 11, 2020
  • Within the first 4 months of 2020, over 3 million people were infected worldwide and over 230,000 died from COVID-19
  • Almost a year later, there are more than 105 million cases worldwide and over 2.3 million deaths.
  • Spread through respiratory droplets via person-to-person contact or touching a surface on which infected droplets have landed
  • Symptoms may not be present up to 14 days after infection, increasing the risk of unintended transmission
  • An enveloped virus similar to other coronaviruses like SARS and Middle East respiratory syndrome (MERS); this envelope helps the virus enter cells and protects the virus from destruction 
  • Once inside the cell, the virus takes over the host cell machinery and multiplies, leading to increased viral load and spreading of the virus to other parts of the body
  • Causes heart and kidney injury, which are associated with COVID-19-related mortality; acute kidney injury has been reported in ~15% of hospitalized patients; cardiovascular complications have been reported in ~20% of hospitalized patients
  • Individuals at high risk for disease progression are those who are >60 years of age; have underlying health problems such as lung disease, hypertension, cardiovascular disease, kidney disease, diabetes, obesity, malignancy; or are taking immunosuppressants

Product Pipeline

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

RBT-1 is a newly developed combination product designed to induce preconditioning of the kidney, upregulating production of protective proteins to prevent AKI during cardiac surgery.

Preclinical: Complete. Conditioning Rx protects against AKI, hepatic injury, and cardiac injury in response to AKI in animal models. 

Phase I is complete and a Phase II study is anticipated to begin in 1H, 2021.

RBT-2: Tetrahydrodiferuloylmethane

RBT-2  (tetrahydrodiferuloylmethane) is an active metabolite of an antioxidant natural product that reduces CKD progression by restoring cellular homeostasis and reducing inflammation and fibrosis development. Protective effects of RBT-2 have also been observed in the heart. RBT-2 is also effective in diabetes-mediated CKD.

RBT-3:  Iron
Sucrose (FeS)

RBT-3 is being developed to treat iron deficiency anemia. RBT-3 rapidly increases plasma ferritin without inducing nephrotoxicity or cardiotoxicity. Phase II development with RBT-3 is expected to begin in 1H, 2022.

RBT-9: Treatment of
Enveloped Viruses

Rénibus Therapeutics® is developing a novel antiviral therapy RBT-9 (Stannous protoporphyrin [SnPP]) for the treatment of COVID-19 in patients with mild to moderate infection who are at high risk for disease progression. RBT-9 reduces the viral load of several enveloped viruses and protects organs by mitigating viral-induced inflammation and upregulating the production of protective proteins. Our therapeutic goal is to both decrease SARS-CoV-2 viral load and upregulate intrinsic tissue defense pathways, thereby preventing SARS-CoV-2-mediated organ injury and improving medical outcomes.

Rénibus Therapeutics® has received a Fast Track designation from the FDA for the use of RBT-9 in the treatment of COVID-19. The Phase II trial is now enrolling.

Rénibus News

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

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

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

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

Presentations at the American Society of Nephrology Kidney Week 2020

RBT-9 Antiviral Activity Against SARS-CoV-2

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

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

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

Renibus Therapeutics® Receives FDA Fast Track Designation for RBT-9 Treatment in COVID-19

Preclinical studies have shown that RBT-9 protects various organs, including the lung, heart, kidney, and liver. Importantly....

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...

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

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

Executive Order on Advancing American Kidney Health. The administration is dedicated to advancing kidney health.

The state of care for patients with chronic kidney disease and end-stage renal disease (ESRD) is unacceptable...

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Rénibus Therapeutics® Inc.

181 Grand Ave,
Suite 225,
Southlake, TX 76092

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