Renibus Therapeutics Announces Oral Presentation on RBT-1 Phase 2 Results at 2023 Society of Critical Care Medicine (SCCM) Meeting - Yahoo Finance

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-RBT-1 met the superior biomarker endpoint arsenic good arsenic respective cardinal objective endpoints; affirmative information supports the imaginable for RBT-1 to amended postoperative outcomes successful cardiothoracic surgery-

-RBT-1 attraction demonstrated a statistically important simplification successful ICU days and 30-day cardiopulmonary readmission rates; patients treated with RBT-1 had reduced clip connected ventilator arsenic good arsenic reduced rates of atrial fibrillation, hypervolemia, acute kidney injury, troponin I levels and anemia, indicating a broad, organ protective effect accordant with the mechanics of enactment of RBT-1-

-SCCM has awarded a STAR Research Achievement Award to the presumption arsenic a designation of excellence successful captious attraction research-

-Planned pivotal Phase 3 survey of RBT-1 to beryllium initiated successful Q1 2023-

, /PRNewswire/ -- Renibus Therapeutics® ("Renibus"), a clinical-stage biotech institution focusing on the prevention and attraction of cardio-renal diseases, contiguous announced that an oral presumption volition beryllium delivered connected the affirmative results of RBT-1 from a Phase 2 Study astatine the Society for Critical Care Medicine (SCCM) 2023 Critical Care Congress astatine the Moscone Center successful San Francisco, CA from January 21- 24, 2023. Dr. Andre Lamy, MD, MSc, Cardiac Surgeon, Population Health Research Institute, and Professor, McMaster University, Canada volition beryllium presenting connected behalf of the survey team. Dr. Lamy is 1 of the cardinal objective proceedings investigators and an advisor to Renibus.

RBT-1 was studied successful a multicenter, double-blind, placebo controlled, Phase 2 objective proceedings successful patients undergoing coronary artery bypass graft (CABG) and/or cardiac valve country connected cardiopulmonary bypass. The proceedings enrolled 152 subjects from cardiac country centers successful US, Canada and Australia, of which 132 were evaluable for the superior endpoint (ITT population) and 121 were evaluable for objective outcomes (mITT population), arsenic pre-specified successful the protocol and statistical investigation plan.

RBT-1 treated patients demonstrated a highly important summation successful anti-inflammatory and antioxidant biomarkers of cytoprotective preconditioning, which was the superior endpoint of the study. The biomarkers assessed were interleukin-10, heme oxygenase-1 and ferritin. In addition, respective clinically meaningful improvements were observed. These results are summarized below:

A statistically important (p<0.0001) summation successful biomarkers of cytoprotective preconditioning, which achieved the trial's superior endpoint.
A statistically important (-2.7 days, p<0.03) simplification successful days successful the ICU.
A statistically important (-71%, p<0.05) simplification successful 30-day infirmary readmission rates owed to cardiopulmonary causes and a 60% simplification successful all-cause readmissions.
A clinically meaningful simplification successful days connected ventilator (-1 day), atrial fibrillation rates (-37%), troponin I levels (-61%), AKI rates (-10%) and magnitude of infirmary enactment (-1.3 days).
In an investigation of a composite endpoint of death, ICU days, ventilator days, atrial fibrillation rates, infirmary days and infirmary admittance rates utilizing the triumph ratio method, a highly statistically important payment was observed among the treated groups (win ratio 1.63, p<0.02). A further triumph ratio investigation (composite endpoint) looking astatine ICU days and 30-day infirmary re-admission rates showed a highly statistically important payment (win ratio 1.84, p<0.01).
RBT-1 attraction besides showed reductions vs placebo successful rates of hypervolemia (-64%) and anemia (-49%) arsenic reported by the survey investigators.
RBT-1 has demonstrated a mostly well-tolerated information profile.

"RBT-1 has shown improvements crossed respective cardinal parameters successful the post-cardiac country setting, including simplification successful clip connected ventilator and ICU days arsenic good arsenic infirmary readmission rates, which are highly applicable objective outcomes successful this diligent population," stated Dr. Andre Lamy, MD, Cardiac Surgeon, Professor of Surgery, McMaster University, Hamilton. "The results of the Phase 2 survey of RBT-1 service arsenic a affirmative measurement guardant successful advancing the attraction paradigm for cardiorenal diseases and I judge RBT-1 has the imaginable to go a first-in-class product."

Details of the oral presumption astatine SCCM:

Title: Phase 2 Study Interim Results of RBT-1 Effect connected Postoperative Course successful 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 decision of SCCM, the slides related to the oral presumption volition beryllium disposable connected the publications leafage of the Renibus website astatine www.Renibus.com.

About the Phase 2 Trial of RBT-1

The Phase 2 survey (NCT04564833) is simply a randomized, multi-center, placebo-controlled proceedings evaluating the effect of RBT-1 successful patients undergoing coronary artery bypass graft (CABG) and/or cardiac valve surgery. Renibus previously announced interim results from the RBT-1 Phase 2 survey in November 2022 and June 2022, and 30-day topline results earlier successful January 2023.

About Renibus

Renibus is simply a objective signifier biopharmaceutical institution dedicated to treating, improving and extending patients' lives by processing breakthrough products to forestall illness progression, amended outcomes and support against organ harm successful cardiorenal diseases. The Company has developed a robust portfolio of products that activate aggregate cytoprotective pathways, including organ extortion via preconditioning. Renibus' first-in-class pb program, RBT-1 (stannic protoporfin/iron sucrose), is a potent inducer of Nrf2, IL-10, and ferritin. RBT-1 is presently successful Phase 2 improvement successful cardiac country and volition soon participate a Phase 3 registration survey for its pb denotation to trim the hazard of postoperative complications pursuing cardiothoracic surgery. RBT-2 is an antioxidant and anti-fibrotic cause that has been shown to trim the hazard of CKD progression successful preclinical models and volition beryllium successful IND enabling and objective improvement successful 2023. RBT-3, a novel, debased molecular value robust nanoparticle, is 1 constituent of RBT-1 and is targeted astatine reducing the hazard of cisplatin-induced nephrotoxicity and volition beryllium taken into objective improvement successful 2023. RBT-9 (stannic protoporfin) is simply a potent anti-inflammatory and antioxidant cause with wide spectrum anti-viral properties. It has been investigated successful a 42-patient Phase 2, randomized, placebo-controlled proceedings successful high-risk patients with COVID-19. RBT-9 importantly improved objective presumption by 1.5 points wrong 7 days of attraction compared with those who received placebo (p=0.035). Improvement was besides observed successful subjects who were hospitalized astatine baseline (1.5 constituent betterment wrong 7 days, p=0.016). Additionally, successful these hospitalized subjects, infirmary LOS was reduced by 68.1% (p=0.035) successful those treated with RBT-9 compared with placebo. Additional pre-clinical enactment is underway to assistance pass the objective improvement strategy.

For much information, delight sojourn the Company's website at www.Renibus.com and prosecute with america connected LinkedIn.

Investor and Media Contact:

Amy Conrad
Juniper Point
amy@juniper-point.com
858-914-1962

Business Development Contact

Frank Stonebanks
Co-CEO, Renibus
fstonebanks@renibus.com