Guard Therapeutics announced that the German medicines regulator, the Federal Institute for Drugs and Medical Devices (BfArM), has approved the company's application to conduct a comprehensive clinical phase 2 study of ROSgard, an investigational drug being developed for the prevention and treatment of acute kidney injury. The global study is planned to be conducted in Europe and North America under the guidance of Prof. Dr. Alexander
Zarbock at Münster University Hospital, Germany. 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. 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.