Renibus lands $47m to advance lead program into Phase 3

Cardio-renal disease targeting biopharma Renibus Therapeutics has raised $47 million from the initial closings of a Series B financing round. The funding will be used to advance its lead program (RBT-1) through a pivotal Phase 3 trial.

Renibus is developing products to prevent disease progression, improve outcomes and protect against organ damage associated with cardiorenal diseases and complex surgeries. The company has developed a robust portfolio of products that activate multiple cytoprotective pathways, including organ protection via preconditioning.

Initially being studied in cardiac surgery patients, RBT-1 (stannic protoporfin/iron sucrose) is a potent inducer of anti-inflammatory, antioxidant and iron scavenging pathways that acts as a preconditioning agent.

The Phase 3 trial, expected to commence in Q3 2023, will evaluate RBT-1 for its lead indication of reducing the risk of post-operative complications following cardiothoracic surgery. RBT-1 was granted Breakthrough Therapy designation status from the US FDA for this indication in June.

Renibus completed Phase 2 development of RBT-1 in February and presented positive final data at the American Association for Thoracic Surgery Meeting, which supported the advancement of the program into a Phase 3 study.

“The last few months have been transformational for Renibus, highlighted by the completion of the RBT-1 Phase 2 study demonstrating RBT-1’s potential to prevent organ damage and minimize post-operative complications after cardiac surgery,” said Frank Stonebanks, Co-CEO of Renibus.

“These results, and the FDA’s Breakthrough Designation, catalyzed the $47 million financing announced today. These funds, from existing and new investors, including leaders in the cardiac surgery community, will be used to advance RBT-1 through the planned Phase 3 trial, which is designed to be a standalone pivotal study for submission of a new drug application.”

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