Acesion Pharma Receives Approval for Phase I Study in Atrial Fibrillation at CHDR

COPENHAGEN, Denmark— 8 February 2018: Acesion Pharma (“Acesion” or the Company), a Danish biotech company developing novel treatments for atrial fibrillation (AF), the most common cardiac arrhythmia, announces today it has received approval to commence its first clinical study for its lead compound AP30663. The phase 1 study in healthy subjects will be conducted at the Centre for Human Drug Research (CHDR) in the Netherlands and is due to start in March 2018.

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.

Acesion is developing a portfolio of drugs addressing both acute and persistent AF. 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.

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.

Read the full press release here