Prime Highlights
- Acesion Pharma has launched a Phase 2 clinical trial of AP31969, a novel oral drug aimed at improving rhythm control in patients with atrial fibrillation.
- The treatment is designed to reduce heart rhythm risks linked to existing therapies, positioning it as a potentially safer option for patients.
Key Facts
- The Phase 2 study will enroll around 200 patients across eight European countries and is expected to conclude in early 2027.
- All participants will receive implantable loop recorders to continuously monitor heart rhythm and assess both effectiveness and safety.
Background:
Acesion Pharma has started a Phase 2 trial of its experimental atrial fibrillation drug, AP31969. The drug is a first-of-its-kind oral SK ion channel inhibitor aimed at controlling heart rhythm with fewer safety risks than current therapies.
The randomised, double-blind, placebo-controlled study will include around 200 patients across eight European countries. According to the company, the trial is expected to conclude in the first quarter of 2027. The first participants have already entered the study, signalling the official start of the next development phase for the drug.
The trial will assess whether the drug can reduce the time patients spend in atrial fibrillation. Safety will be closely monitored, as grave heart rhythm risks have been seen with current treatments.
The Phase 2 trial follows a successful Phase 1 study in 92 healthy volunteers. The earlier study tested different doses of AP31969 and looked at how the drug behaves in the body and its effect on heart rhythm. Acesion said the drug was well-tolerated and showed no meaningful risk to heart rhythm, supporting its use as a long-term oral treatment.
Commenting on the development, Acesion Chief Executive Officer Anders Gaarsdal Holst said the transition into Phase 2 represents a key milestone for the company. He highlighted that the trial’s design allows for a robust evaluation of both efficacy and safety at an early stage, which could help streamline later-stage development.
Acesion says AP31969 could become a first-choice treatment for atrial fibrillation by reducing the heart rhythm risks seen with current drugs. The company also noted that AF cases in the US and Europe are expected to reach about 25 million by 2030, highlighting the growing need for safer treatments.
