Phase 1 data show favourable safety profile
Data support further development of AP30663 for cardioversion therapy
Acesion Pharma (“Acesion” or the Company), a Danish biotech company developing novel treatments for atrial fibrillation (AF), the most common cardiac arrhythmia, announces positive results from the Phase 1 clinical trial of its lead compound AP30663. The results of the study demonstrated that intravenous AP30663 was well tolerated with ascending doses, with no significant adverse events. Atrial fibrillation (AF) is the most common cardiac arrhythmia, affecting an estimated 10 million people in the US and the EU (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. Acesion’s novel approach is based on inhibition of SK channels - ion channels present in the atria where they 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 cardiac safety profile.
Commenting on the news, Frans Wuite, CEO of Acesion Pharma said: “It is very exciting to see these promising Phase 1 results that indicate safety even at levels above expected therapeutic doses. This is an important milestone for AP30663 and validates the concept of SK-inhibition for atrial fibrillation and thereby the promise of Acesion’s portfolio. We will continue to progress the development of AP30663 for cardioversion therapy and are preparing to initiate a Phase 2 study in the second quarter of 2019.” The Phase 1 study was a randomized, double-blind, placebo-controlled single ascending dose study to assess the safety and tolerability of AP30663 in 47 healthy subjects, conducted at the Centre for Human Drug Research (CHDR) in the Netherlands. The subjects were exposed to plasma concentrations within and above the predicted therapeutic range. Based on the encouraging data, Acesion aims to conduct a Phase 2 Proof-of-Concept study in AF-patients who suffer from atrial fibrillation that has lasted up to 7 days. Prof John Cammi, Scientific Advisor to Acesion Pharma and Professor of Clinical Cardiology at St George's Hospital Medical School, London, added: “Atrial fibrillation is increasingly common, and the medical community must make a special effort to find new and more successful therapies to treat this condition. When the rhythm disturbance begins it is often very symptomatic and distressing – it requires urgent and effective treatment - but to date available therapies are far from optimal. AP30663 has the potential to be the solution that we need. Prompt and effective treatment of this heart rhythm disturbance promises to significantly reduce the long-term consequences of the disease.”