Renibus’ cardiac surgery drug aces phase 2 trial as biotech adds extra CEO

Renibus Therapeutics’ lead candidate for patients undergoing cardiac surgery has sailed through a phase 2 trial, setting up the Texan biotech for a late-stage study in the coming months as it also unveiled a double-dose of CEOs.

The therapy, dubbed RBT-1, is a novel stannous protoporphyrin and iron sucrose fixed-combination agent designed to induce the upregulation of biomarkers of cytoprotective preconditioning. The aim is to prevent complications that arise after cardiothoracic surgery.

So far, it seems RBT-1 fits the bill. Across the 132 evaluable patients in the U.S., Canada and Australia who underwent a coronary artery bypass graft, RBT-1 was shown to hit the primary endpoint of increasing biomarkers of cytoprotective preconditioning. Beyond that, the drug was also associated with an average 2.7-day reduction in ICU stay, as well as a 60% reduction in readmissions to the hospital for any cause.

"These positive topline data provide strong support for RBT-1's potential to reduce the risk of multiorgan injury and thereby improve postoperative outcomes in patients undergoing cardiothoracic surgery," said Chief Medical Officer Bhupinder Singh, M.D. "We are well positioned to advance RBT-1 into a phase 3 registrational study in the first quarter of 2023."

Renibus used the readout to also reveal that Jeff Keyser, Ph.D., will be joining Frank Stonebanks as co-CEO. The company has been filling out its executive team over the past year, with the appointment of Singh and a new Chief Financial Officer announced in June.

Behind RBT-1 are a couple of preclinical candidates that Renibus has high hopes for. The company hopes to get RBT-2, an antioxidant and anti-fibrotic drug designed to halt the progress of chronic kidney disease, into the clinic this year. Then there’s RBT-3, a low molecular weight iron nanoparticle aimed at reducing the risk of cisplatin-induced nephrotoxicity that the biotech also hopes to begin human trials in 2023.

The company also has an anti-inflammatory and antioxidant drug called RBT-9 in its locker. The drug has anti-viral properties and has undergone a phase 2 trial in patients with COVID-19, where it was shown to reduce the length of hospital stay by around 70%. Renibus said it’s now conducting additional pre-clinical work to help decide on a clinical development strategy.

The company raised $33 million in a November 2022 bridge financing deal to advance its cardiorenal portfolio.