Candidate AP30663 is an inhibitor for the conversion of atrial fibrillation to a normal sinus rhythm.
Acesion Pharma – a company focused on novel therapies for atrial fibrillation (AF) – has announced positive results from a phase 2 trial of its candidate, AP30663. The therapy is a first-in-class SK ion channel inhibitor for the conversion of AF to a normal sinus rhythm.
The trial was placebo-controlled, randomised, double-blind and multi-national. The study enrolled 63 patients with a current episode of AF – the most common cardiac arrhythmia – and examined the performance of two intravenous doses of AP30663 compared to the placebo.
Meanwhile, the primary endpoint was the proportion of patients with AF conversion to sinus rhythm within 90 minutes of infusion commencing.
In addition, the research employed a ‘Bayesian analysis’ involving a probability less than 99.9% of a true AF conversion rate greater than the placebo across the two doses. The results from the Bayesian analysis were supported by traditional analysis of the primary endpoint, demonstrating significant P-values for each dose compared to the placebo.
The safety profile was also consistent with that observed in the previous phase 1 trial with AP30663, while the therapy was well tolerated, with no serious adverse events reported among the groups. The main safety concern with available AF treatments – ventricular arrhythmias – was not apparent throughout the trials.
John Camm, emeritus professor of clinical cardiology at St George’s University of London, reflected: “There is a great unmet need for safer AF treatments that can decrease the risk for patients, but also remove barriers for physicians wanting to keep their patients in sinus rhythm by treating them with an antiarrhythmic drug. This novel mechanism holds the promise to deliver on these aspects.”
Anders Gaarsdal Holst, chief executive officer at Acesion, concluded: “This clinical trial has proven the general mechanism of action of SK channel inhibition for the treatment of AF. It further de-risks our pipeline of small molecule SK inhibitors, including AP31969, our ongoing second generation oral lead programme, which targets the much broader and chronic treatment indication of sinus rhythm maintenance.”
Acesion is now advancing an oral SK channel inhibitor programme for chronic maintenance treatment to prevent AF recurrence. The condition is predicted to affect 24 million people in the US and EU by 2030.