Guard Therapeutics International AB (publ) announced that the U.S. Food and Drug Administration (FDA) has granted the company's Investigational New Drug (IND) application for the investigational drug RMC-035 (ROSgard). The approval enables expansion of the clinical development program for RMC-035 to the US, including the ongoing global and placebo-controlled Phase 2 study AKITA in cardiac surgery. The investigational drug RMC-035 is being developed as an intravenous short-term treatment against acute kidney injury and is currently being evaluated in a comprehensive global Phase 2 study, AKITA, to document its renal protective effect in patients undergoing open heart surgery.

The study is planned to include approximately 270 patients. In addition, a smaller Phase 1b study is underway in patients undergoing kidney transplantation.