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Rénibus Therapeutics Inc. (RTI)

is a clinical-stage biotech company focused on the development of novel pharmacologic therapies for acute and chronic kidney disease. Acute Kidney Injury (AKI) remains a significant, unmet medical need with no approved treatment. Postoperative AKI occurs in approximately 30% of patients undergoing cardiac surgery and significantly increases the risk of death (Rosner 2006). Progression to chronic kidney disease (CKD) within 24 months occurs in approximately 15-20% of patients who survive AKI (Chawla 2012). CKD affects 30 million people in the US and has a higher mortality rate than breast cancer, lung cancer, diabetes, and heart failure combined. With no treatment available to stop the progression of CKD, this disease remains a significant healthcare burden.

RTI’s lead product, RBT-1, is a novel pharmacologic intervention that activates the kidney’s natural protective redox signaling pathways, forming a kidney shield. RBT-1 represents a novel medical approach for the prevention of AKI in patients who are undergoing cardiac surgery. Phase I development is nearing completion, and a Phase II study is anticipated to begin in 1H, 2020. RBT-2 is an antifibrotic antioxidant that restores cellular homeostasis in the kidney. RBT-2 is being developed for the treatment of CKD. IND-enabling work with RBT-2 is currently in progress, and it is anticipated that a Phase I study will be conducted in 1H, 2020. 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, 2020.

Due to the recent Covid-19 global health crisis, Renibus Therapeutics is developing a novel anti-viral therapy RBT-9[Stannous protoporphyrin (SnPP)]  for the treatment of COVID-19 at the early stage (Stage I) in patients who are asymptomatic or mildly symptomatic and at high risk for disease progression. Renibus Therapeutics is investigating the effect of RBT-9 to reduce viral load and simultaneously precondition the body to boost cytoprotective anti-inflammatory responses that preserve functional and structural organ integrity. Therefore, via separate mechanisms, RBT-9 may benefit patients with COVID-19 by both inhibiting viral activity and preventing organ failure.

Renibus Therapeutics has received a fast track designation 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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Bhupinder Singh, MD, FASN, FNKF, FCRS

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Henrik Rasmussen, MD, PHD

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William G. Kramer, PhD

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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 morality 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 the 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
  • Significant unmet medical need that represents a costly burden in the US Healthcare system and financial burden on patients. The Medicare cost in 2018 was 119 B and commercial insurance cost would be substantial as well. It is likely similar public cost burdens 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
  • Has spread to over 180 countries and all 50 states in the United States
  • Within the first 4 months of 2020, over 3 million people were infected worldwide and over 230,000 died from COVID-19
  • 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 strengthen the kidneys of at risk cardiovascular surgery patients, preventing AKI.

Preclinical: Complete. Conditioning Rx protects against AKI, hepatic injury,and cardiac injury in response to AKI in animal models. Plasma and urine HO-1 assay serves as a bioassay of gene induction.

Phase I is nearly complete. Early data is encouraging.

RBT-2: Optimized Tetrahydrodiferuloylmethane

RBT-2  (optimized tetrahydrodiferuloylmethane) is an antifibrotic antioxidant that activates a cascade of antioxidant enzymes to quench free radical formation. RBT-2 reduces CKD progression by restoring cellular homeostasis, reducing inflammation and development of fibrosis. Concomitantly RBT-2  reduces blood pressure and proteinuria. RBT-2  effective in different types of CKD, including diabetes mediated CKD and sub-total nephrectomy.

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 cardiotoxicty. Phase II development with RBT-3 is expected to being in 1H, 2020.

RBT-9: Treatment of
Enveloped Viruses

Renibus Therapeutics is developing a novel antiviral therapy RBT-9 (Stannous protoporphyrin [SnPP]) for the treatment of COVID-19 at the early stage (Stage I) of infection in patients who are at high risk for disease progression. RBT-9 is an agent that preconditions the body to combat insult and injury by boosting cytoprotective, anti-inflammatory responses that preserve functional and structural organ integrity. In addition to broad organ protection, RBT-9 possesses antiviral activity, which has been demonstrated against several enveloped viruses. Our therapeutic goal is to both decrease SARS-CoV-2 viral loads and upregulate intrinsic tissue defense pathways, thereby preventing SARS-CoV-2-mediated organ injury and improving medical outcomes.

Renibus 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

Presentations at the American Society of Nephrology Kidney Week 2020

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RBT-9 Antiviral Activity Against SARS-CoV-2

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

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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

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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

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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....

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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...

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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

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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

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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.

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Headquarters

Rénibus Therapeutics Inc.

181 Grand Ave,
Suite 225,
Southlake, TX 76092

General Inquiries

682-285-1711

Business Development:

busdev@renibus.com

Covid-19 Inquiries

682-285-1733

covid19trials@renibus.com

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