In spring 2019, the first clinical (first-in-human) study of ROSgard was initiated. A clinical phase 1 program including three separate studies has been successfully completed and demonstrates a favorable safety profile and appropriate pharmacokinetics of ROSgard for the future treatment of acute kidney injures (AKI). All studies were conducted in Sweden.
The following studies were completed with positive results:
In summary, the results of the phase 1 program demonstrates that ROSgard has a favorable safety profile and pharmacokinetic characteristics and provide a solid foundation for future studies in patients undergoing open chest cardiac surgery (i.e. with use of heart-lung machine).
In summary, the phase 1 results demonstrate that ROSgard is safe and generally well tolerated and provide a solid foundation for continued clinical development in patients undergoing open-chest cardiac surgery with use of cardio-pulmonary bypass.
In parallel, preparations are ongoing for a planned phase 2 program to be conducted both in the US and in EU. The primary purpose of a phase 2 study is to demonstrate a clinically relevant treatment effect in the target patient population, i.e. patients at increased risk for developing acute kidney injury (AKI) after open chest cardiac surgery. The design of the phase 2 study will be completed based on regulatory feedback be the US Food and Drug Administration (FDA) and leading global clinical experts and key opinion leaders in the field.