Guard Therapeutics today announces that the first patient has been dosed in the company's global phase 2 clinical trial of ROSgard. The study is conducted in patients who undergo open heart surgery and thus are at risk of developing acute kidney injury. The results are expected to provide conclusive information on the treatment effect of the investigational drug in this patient group and to guide the design of a subsequent pivotal study.
The first patient in the study was recruited at an investigational center in Germany. Patient recruitment is now continuing in Germany and has in parallel also begun in Canada. The study is expected to expand to additional European countries in the second quarter, and the company intends to include trial centers in the US during the second half of 2022.
"The fact that the phase 2 clinical trial of ROSgard has now begun is an important milestone in the development of our drug candidate. We look forward to expanding the study to more countries and trial centers to complete the recruitment of the approximately 270 patients planned to be included in the study as quickly as possible," says Guard Therapeutics CEO, Tobias Agervald.
The investigational drug ROSgard has the ability to counteract severe oxidative stress – a common denominator for many different types of acute kidney injury. Guard Therapeutics has chosen to prioritize treatment in connection with open heart surgery and use of a heart-lung machine in the initial clinical development phase. There is also a possibility to expand the clinical program to other segments, such as patients undergoing kidney transplantation.
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