Renibus Therapeutics Announces Oral Presentation on RBT-1 at the 38th European Association for Cardio-Thoracic Surgery (EACTS) Annual Meeting

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Oct 09, 2024, 08:00 ET

- Renibus is actively enrolling a Phase 3 pivotal trial to reduce the risk of post-operative complications and improve outcomes following cardiac surgery -

SOUTHLAKE, Texas, Oct. 9, 2024 /PRNewswire/ -- Renibus Therapeutics® ("Renibus"), a clinical-stage biopharmaceutical company focusing on the prevention and treatment of cardiac, renal, and metabolic diseases, today announced that an oral presentation will be delivered on RBT-1 at the 38^th EACTS Annual Meeting, taking place October 9-12, 2024, in Lisbon, Portugal. Charles Mack, MD, FACS, Associate Professor of Cardiothoracic Surgery and Vice Chairman of Quality and Patient Safety, New York-Presbyterian Hospital, Weill Cornell Medicine, will be presenting on behalf of Renibus.

RBT-1 is a single-dose, preconditioning agent that is administered intravenously 24-48 hours prior to patients undergoing non-emergent cardiac and/or valve surgery. Renibus is actively enrolling a Phase 3 pivotal trial of RBT-1 to reduce the risk of post-operative complications and improve outcomes following cardiac surgery. RBT-1 has received Breakthrough and Fast Track Designations from the US FDA.

"We are thrilled that EACTS has recognized RBT-1 with an oral presentation to share our promising results with the global cardiothoracic surgery community," stated Jeffrey Keyser, RPh, JD, PhD, President and CEO of Renibus. "Enrollment in the RBT-1 Phase 3 PROTECT study is ahead of schedule, and we remain on track to report top-line data in the second quarter of 2025."

"RBT-1 has shown great potential in our Phase 2, multi-center, randomized, double-blind, placebo-controlled study," said Charles A. Mack, MD, FACS, Associate Professor of Cardiothoracic Surgery, New York-Presbyterian Hospital, Weill Cornell Medicine. "I am excited to present new data from a post-hoc analysis, which included all patients regardless of surgery delay, showing that the improvement in clinical outcomes in response to RBT-1 treatment was maintained."

Details of the oral presentation at EACTS Annual Meeting:

Title: Effect of RBT-1 on Clinical Outcomes the Safety Population of a Phase 2 Study in Cardiac Surgery
Date and Time: Friday, October 11, 2024, 9:15 am
Presenting Author: Charles Mack, MD

Authors: C. Mack (New York, USA), M. Jessen (Dallas, USA), A. Shaw (Cleveland, USA), S. Ruiz (Southlake, USA), C. Wang (Piscataway, USA), S. Snapinn (Seattle, USA), B. Singh (Southlake, USA), A. Lamy (Ontario, Canada)

About RBT-1

RBT-1 (stannic protoporfin/iron sucrose) is a potent inducer of anti-inflammatory and antioxidant pathways currently in Phase 3 [NCT # 06021457] for its lead indication to reduce post-operative complications following cardiothoracic surgery. Renibus completed the Phase 2 study of RBT-1 (NCT04564833) in February 2023 and announced positive final results from this study in May 2023. In October 2023, Renibus initiated enrollment and administration of RBT-1 in its PROTECT Phase 3 pivotal study.

RBT-1 was granted Breakthrough Therapy designation status from the U.S. FDA to reduce the risk of complications in patients undergoing cardiothoracic surgery.

About Renibus Therapeutics

Renibus is a clinical stage biopharmaceutical company dedicated to treating, improving, and extending patients' lives by developing products to prevent disease progression, improve outcomes and protect against organ damage associated with cardio, renal and metabolic diseases. Renibus' first-in-a-new class lead program is RBT-1 (stannic protoporfin / iron sucrose), a single dose IV drug that is given over 1-2 hours, 24-48 hours prior to patients undergoing elective cardiac and/or valve surgery. It is in a Phase 3 pivotal trial to reduce the risk of post operative complications and improve outcomes following cardiothoracic surgery. The drug has received FDA Breakthrough and Fast Track Designations.

Veverimer is an oral, non-absorbed hydrochloric acid binder that was acquired from Tricida. We are currently evaluating veverimer in preclinical models and analyzing historical data to further our understanding of its clinical profile with a goal of identifying an indication for evaluation in clinical trials. Renibus has three additional assets at earlier stages of development.

For more information, please visit the Company's website at www.Renibus.com and engage with us on LinkedIn.

Investor and Media Contact:

Amy Conrad
Juniper Point
[email protected]
858-914-1962

Business Development Contact

Jamie Donadio
CFO, Renibus
[email protected]

SOURCE Renibus Therapeutics