Renibus Therapeutics, a clinical-stage biopharmaceutical company based in Southlake, Texas, has successfully raised $47 million in funding to advance the development of its promising drug RBT-1 for reducing postoperative complications following cardiothoracic surgery.
The funding came from a group of undisclosed backers, and it marks a significant milestone for the company as it moves forward in its mission to improve patient outcomes and protect against organ damage associated with cardiorenal diseases and complex surgeries.
Promising results from the Phase 2 study
Renibus Therapeutics’ lead program, RBT-1, has shown great potential in reducing postoperative complications. In a completed Phase 2 study, which concluded in February 2023, RBT-1 demonstrated its effectiveness as a potent inducer of anti-inflammatory, antioxidant, and iron-scavenging pathways.
The study involved randomized, double-blind, and placebo-controlled trials with patients undergoing elective coronary artery bypass graft and cardiac valve surgery. The positive final results from this study, announced in May 2023, have provided strong support for advancing RBT-1 into a pivotal Phase 3 trial.
The impressive results from the Phase 2 study led to the US Food and Drug Administration (FDA) granting Breakthrough Therapy designation to RBT-1 in June 2023.
This designation recognizes the drug’s potential to reduce the risk of complications in patients undergoing cardiothoracic surgery. It also highlights the significance of RBT-1 as an innovative and transformative treatment option in the medical field.
Funding to advance pivotal Phase 3 trial
With the $47 million in funding secured from existing and new investors, Renibus Therapeutics is now fully equipped to advance RBT-1 through a pivotal Phase 3 trial.
This trial will be a standalone pivotal study, providing the necessary data to submit a new drug application. The Phase 3 trial aims to enroll approximately 400 patients, further evaluating the drug’s efficacy in reducing the risk of postoperative complications following cardiothoracic surgery.
Revolutionizing patient care and reducing healthcare costs
The successful funding round and breakthrough therapy designation demonstrate investors’ and healthcare professionals’ confidence in Renibus Therapeutics and the potential of RBT-1.
By reducing post-surgical complications, RBT-1 has the potential to benefit patients and healthcare systems worldwide greatly. Postoperative complications can be detrimental to patient recovery and costly for the healthcare system. The innovative approach of RBT-1 not only aims to improve patient outcomes but also has the potential to save a significant amount of money for the healthcare system.
Looking ahead, Renibus Therapeutics plans to submit a new drug application to the FDA upon completing the Phase 3 trial. The company will also explore options for financing the commercialization of RBT-1, including additional investor funding or potentially going public.
With a robust pipeline of four drugs and the recent acquisition of intellectual property and inventory for the kidney disease drug Veverimer, Renibus Therapeutics continues to make significant strides in the biopharmaceutical industry.
With positive results from a Phase 2 study and the FDA’s Breakthrough Therapy designation, Renibus Therapeutics aims to revolutionize patient care, improve outcomes, and reduce healthcare costs.