A double-blind, randomized, placebo-controlled Phase 2 clinical trial for APN01 was initiated in April 2020 in several European countries (UK, Germany, Austria, and Denmark) and later also in Russia. In total 24 clinical centres were included. Patient recruitment will be completed in 2020. Efficacy data are expected by early 2021.
Once clinical efficacy is proven we are aiming for an accelerated approval in close cooperation with the European Medical Association (EMA).
In addition to its investigation as a potential therapeutic to combat COVID-19, APN01 has successfully completed several clinical trials in severe respiratory diseases like acute lung injury (ALI), acute respiratory distress syndrome (ARDS) and pulmonary arterial hypertension (PAH).
*APN01 is an investigational agent and has not been approved by the U.S. Food and Drug Administration, the European Medicines Agency, or any other regulatory agencies.