The randomised, double-blind, placebo-controlled global phase 2 study of ROSgard is expected to include around 270 patients who are undergoing open heart surgery and are thus at risk of developing acute kidney injury. The study is planned to start in the first quarter of 2022 and German study centres are expected to recruit a significant proportion of the total number of patients. The company awaits ethical approval of the study as a last step in the German clinical trial application procedure before the study can start.
 
“The positive announcement from the German medicines regulator is the first regulatory approval of this comprehensive global phase 2 study of ROSgard and is an important milestone that supports our plan to start the study in the first quarter of 2022. The approval also reflects the quality of the documentation we have generated so far for our investigational drug and our ability to meet the strict regulatory requirements defined in the regulatory process for obtaining a trial permit,” Guard Therapeutics’ CEO, Tobias Agervald, says.
 
Among other properties, the investigational drug ROSgard has the ability to counteract severe oxidative stress, which is a common denominator for many types of acute kidney injury. In the initial clinical development phase Guard Therapeutics has chosen to give priority to treatment in connection with open heart surgery using a heart-lung machine. In case of a positive outcome, the global phase 2 study is expected to pave the way for a subsequent registrational study. There is also an option to expand the continued clinical programme to other segments, such as patients undergoing kidney transplants.