-RBT-1 met the primary biomarker endpoint as well as several key clinical endpoints; positive data supports the potential for RBT-1 to improve postoperative outcomes in cardiothoracic surgery-
–RBT-1 treatment demonstrated a statistically significant reduction in ICU days and 30-day cardiopulmonary readmission rates; patients treated with RBT-1 had reduced time on ventilator as well as reduced rates of atrial fibrillation, hypervolemia, acute kidney injury, troponin I levels and anemia, indicating a broad, organ protective effect consistent with the mechanism of action of RBT-1-
–SCCM has awarded a STAR Research Achievement Award to the presentation as a recognition of excellence in critical care research-
-Planned pivotal Phase 3 study of RBT-1 to be initiated in Q1 2023-
Southlake, Texas, January 19, 2023 – Renibus Therapeutics® (“Renibus”), a clinical-stage biotech company focusing on the prevention and treatment of cardio-renal diseases, today announced that an oral presentation will be delivered on the positive results of RBT-1 from a Phase 2 Study at the Society for Critical Care Medicine (SCCM) 2023 Critical Care Congress at the Moscone Center in San Francisco, CA from January 21- 24, 2023. Dr. Andre Lamy, MD, MSc, Cardiac Surgeon, Population Health Research Institute, and Professor, McMaster University, Canada will be presenting on behalf of the study team. Dr. Lamy is one of the key clinical trial investigators and an advisor to Renibus.
RBT-1 was studied in a multicenter, double-blind, placebo controlled, Phase 2 clinical trial in patients undergoing coronary artery bypass graft (CABG) and/or cardiac valve surgery on cardiopulmonary bypass. The trial enrolled 152 subjects from cardiac surgery centers in US, Canada and Australia, of which 132 were evaluable for the primary endpoint (ITT population) and 121 were evaluable for clinical outcomes (mITT population), as pre-specified in the protocol and statistical analysis plan.
RBT-1 treated patients demonstrated a highly significant increase in anti-inflammatory and antioxidant biomarkers of cytoprotective preconditioning, which was the primary endpoint of the study. The biomarkers assessed were interleukin-10, heme oxygenase-1 and ferritin. In addition, several clinically meaningful improvements were observed. These results are summarized below:
- A statistically significant (p<0.0001) increase in biomarkers of cytoprotective preconditioning, which achieved the trial’s primary endpoint.
- A statistically significant (-2.7 days, p<0.03) reduction in days in the ICU.
- A statistically significant (-71%, p<0.05) reduction in 30-day hospital readmission rates due to cardiopulmonary causes and a 60% reduction in all-cause readmissions.
- A clinically meaningful reduction in days on ventilator (-1 day), atrial fibrillation rates (-37%), troponin I levels (-61%), AKI rates (-10%) and length of hospital stay (-1.3 days).
- In an analysis of a composite endpoint of death, ICU days, ventilator days, atrial fibrillation rates, hospital days and hospital admission rates using the win ratio method, a highly statistically significant benefit was observed among the treated groups (win ratio 1.63, p<0.02). A further win ratio analysis (composite endpoint) looking at ICU days and 30-day hospital re-admission rates showed a highly statistically significant benefit (win ratio 1.84, p<0.01).
- RBT-1 treatment also showed reductions vs placebo in rates of hypervolemia (-64%) and anemia (-49%) as reported by the study investigators.
- RBT-1 has demonstrated a generally well-tolerated safety profile.
“RBT-1 has shown improvements across several key parameters in the post-cardiac surgery setting, including reduction in time on ventilator and ICU days as well as hospital readmission rates, which are highly relevant clinical outcomes in this patient population,” stated Dr. Andre Lamy, MD, Cardiac Surgeon, Professor of Surgery, McMaster University, Hamilton. “The results of the Phase 2 study of RBT-1 serve as a positive step forward in advancing the treatment paradigm for cardiorenal diseases and I believe RBT-1 has the potential to become a first-in-class product.”
Details of the oral presentation at SCCM:
Title: Phase 2 Study Interim Results of RBT-1 Effect on Postoperative Course in Elective CABG/Valve Surgery
Session: Star Research Presentations: Cardiovascular
Date and Time: Saturday, January 21, 2023, 4:15 PM – 4:30 PM
Presenter: Dr. Andre Lamy, MD, MSc, Cardiac Surgeon, Population Health Research Institute, McMaster University, Canada
Following conclusion of SCCM, the slides related to the oral presentation will be available on the publications page of the Renibus website at www.Renibus.com.
About the Phase 2 Trial of RBT-1
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. Renibus previously announced interim results from the RBT-1 Phase 2 study in November 2022 and June 2022, and 30-day topline results earlier in January 2023.
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.enibus’ first-in-class lead program, RBT-1 (stannic protoporfin/iron sucrose), 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 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, 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 taken into clinical development in 2023. 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. RBT-9 significantly improved clinical status by 1.5 points within 7 days of treatment compared with those who received placebo (p=0.035). Improvement was also observed in subjects who were hospitalized at baseline (1.5 point improvement within 7 days, p=0.016). Additionally, in these hospitalized subjects, hospital LOS was reduced by 68.1% (p=0.035) in those treated with RBT-9 compared with placebo. 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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