Last patient recruited to Guard Therapeutics’ phase 1b study of the investigational drug ROSgard

2021-06-17 11:00:00

Guard Therapeutics announces today that all 12 patients have been included in the company’s clinical phase 1b study of ROSgard, which is being conducted in people undergoing open heart surgery who have additional risk factors for acute kidney injury. The study is being conducted at the University Hospital in Münster, Germany. Top-line results are expected to be presented in September 2021.

The phase 1b study is being conducted mainly for the purpose of evaluating the investigational drug’s safety and tolerability profile and its pharmacokinetic properties in patients undergoing open heart surgery who are at increased risk of acute kidney injury (AKI). The results of the study, together with results from previously completed phase 1 studies, will be used as a basis for the final design of a global phase 2 programme in the same indication that is planned to start before the end of the year.

“We are pleased to have reached an important milestone in our ongoing phase 1b study of ROSgard in cardiac surgery patients. The study is an important component in the long-term development of our investigational drug and the results will play a major role in our continued clinical development programme, including the comprehensive phase 2 study that is expected to begin later this year,” 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, where nearly 40 per cent of all patients are estimated to 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 variety of patient groups, is estimated at between SEK 250 and 300 billion and is expected to grow further in the future.