Acesion Pharma (“Acesion” or the Company), a Danish biotech company developing novel treatments for atrial fibrillation (AF), the most common cardiac arrhythmia, announces it has commenced the clinical study for its lead compound AP30663. Acesion is developing a portfolio of drugs addressing both paroxysmal (acute) and persistent AF. AP30663 has successfully completed the preclinical development program demonstrating a good safety profile and efficacy in converting AF to a normal sinus rhythm. The phase 1 study is a randomized, double-blind, placebo-controlled single ascending dose study to assess the safety and tolerability of AP30663 in 48 healthy subjects. The trial is expected to be completed in June 2018 with data expected by the end of August 2018. The trial is being conducted at the Centre for Human Drug Research (CHDR) in the Netherlands. 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 with incapacitating symptoms, which decrease the health-related quality of life and is associated with significant morbidity including a 5-fold increased risk of stroke and a two-fold increase in mortality. Existing drug therapies for AF, using other modes of action, have encountered major safety issues due to their effects on the ventricles, leading to potentially life threatening pro-arrhythmia and/or depression of the myocardial function. In addition, their low level of efficacy and/or tolerability has limited their use, hence there remains a significant need for improved pharmacological treatments. Acesion’s novel approach is based on inhibition of SK channels - ion channels present in the atria that play a role in regulating the cardiac rhythm. Blocking these ion channels with a functionally atrial selective drug helps avoid deleterious effects on the ventricles. Targeting the SK channels thereby constitutes a novel and promising approach for an effective treatment of AF with an expected higher safety and tolerability profile.
Commenting on the news, Frans Wuite, CEO of Acesion Pharma said:
“I am delighted to announce the first in-man study for our lead candidate is progressing as planned. Acesion’s mission is to develop first-in-class treatments that offer unique efficacy and safety profile for atrial fibrillation patients. There is a large unmet medical need for these patients where current treatments have safety, tolerability and efficacy limitations.”