Acesion Pharma has commenced enrolment for its Phase II clinical trial to evaluate the safety and efficacy of AP31969 in patients with atrial fibrillation (AF).
This double-blind, randomised, dose-finding, placebo-controlled study will enrol 200 patients across eight countries in Europe, with completion targeted for the first quarter of 2027.
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The trial’s primary efficacy endpoint is AF burden, which refers to the percentage of time a subject is in AF. An important safety endpoint is the incidence of proarrhythmia events occurring in the heart ventricles.
Ventricular proarrhythmia remains a key safety limitation for current antiarrhythmic medications. To enable thorough evaluation, all participants will receive an implantable loop recorder for continuous cardiac rhythm monitoring.
In 2025, Acesion concluded a Phase I study of AP31969 involving 92 healthy volunteers. The study included multiple-ascending dose and single-ascending dose segments to examine effects, safety, and pharmacokinetics on the QT interval (QTc), an ECG marker indicating proarrhythmia risk.
Acesion Pharma CEO Anders Gaarsdal Holst said: “Advancing our oral lead compound AP31969 into a Phase II clinical trial marks an important milestone for Acesion. With the use of implantable loop recorders in the trial, we can precisely estimate AF burden efficacy, as well as understand the risk of proarrhythmia.
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By GlobalData“Being able to robustly understand both the efficacy and the key safety parameter within a therapy class is unusual in a Phase II cardiovascular trial and, if successful, will greatly de-risk Phase III development and accelerate AP31969’s path to becoming the preferred treatment option for the increasing number of patients suffering from AF.”
AP31969 is being developed as a potential first-line therapy for AF by addressing proarrhythmia risks associated with existing treatments.
The combined AF patient population in the European Union and the US is projected to reach 25 million by 2030.
