Atrial fibrillation is the most common cardiac arrhythmia, affecting at least 10 million people in the US and Europe and 30 million people worldwide. The incidence of AF increases with age and it is estimated that 5-10% of the population above the age of 70 have AF. It is a progressive disease that is associated with significant morbidity and a 5-fold increased risk of stroke. Existing drug therapies for AF, using other modes of action, have encountered major safety issues due to their effects on the ventricles, leading to life threatening pro-arrhythmia and/or depression of the myocardial function. In addition, their efficacy and/or tolerability has limited their use and there remains a significant need for developing better, safer and tolerable treatments.
With the approval of the CTA, Acesion will start the Phase 1 study of AP30663 in March 2018 to determine the safety and tolerability profile of a single ascending dose in healthy subjects. AP30663 has successfully completed the preclinical development program demonstrating a good safety profile and efficacy in converting AF to a normal sinus rhythm.