The key activity of theTraumakine -program is a phase III clinical study aiming at the European marketing authorization of FP-1201-lyo treatment of ARDS. The previously performed clinical study with FP-1201 has indicated significant decrease in mortality of the ALI/ARDS patients with good safety profile.
ARDS is characterized by pulmonary inflammation leading to increased vascular permeability and loss of aerating lung tissues. ARDS is common in many critically ill patients, affecting nearly 175 000 patients/year in Europe alone. This brings with it a substantial fiscal burden for our health care system but also a burden of mortality: some 35-40% fail to survive.