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,”
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
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