Guard Therapeutics today announces that the first patient has been dosed in a phase 1b study of the company’s investigational drug ROSgard. The study is being conducted in patients undergoing open heart surgery who have additional risk factors for acute kidney injury. The phase 1b study is being conducted at Münster University Hospital in Germany.
The results are expected to be presented at the end of the second quarter of 2021 and will, together with previously completed phase 1 studies, form the basis for a global phase 2 programme that is planned to start in the autumn.
“The phase 1b study of ROSgard is the last part of a comprehensive phase 1 programme and the investigational drug will now be evaluated in the primary target group for treatment for the first time. Preparations for our planned global phase 2 programme are going well and we look forward to initiating this in the autumn,” Guard Therapeutics’ CEO, Tobias Agervald, says.
The investigational drug, ROSgard, has the ability to counteract severe oxidative stress – a common denominator for many different types of acute kidney injury. In the initial clinical development phase, Guard Therapeutics has chosen to prioritise treatment in connection with open heart surgery using a heart-lung machine, where it is estimated that nearly 40 per cent of patients develop some form of acute kidney injury. There is also an option to expand the continued clinical programme to other segments, such as patients undergoing kidney transplants. The global market for acute kidney injury, which covers a wide range of patient groups, is estimated at SEK 250–300 billion and is expected to grow further in the future.