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Acesion announces positive atrial fibrillation study

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Candidate AP30663 is an inhibitor of the conversion of atrial fibrillation to 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. This therapy is a first-in-class SK ion channel inhibitor for converting atrial fibrillation to normal sinus rhythm.

The study was placebo-controlled, randomized, double-blind, and multinational. This 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 placebo.

The primary endpoint was the proportion of patients who transitioned from atrial fibrillation to sinus rhythm within 90 minutes of infusion.

Additionally, this study employed a “Bayesian analysis” that included a <99.9% probability of true AF conversion rate higher than placebo at two doses. , which showed significant P-values ​​at each dose compared to placebo.

The safety profile was also consistent with that observed in previous Phase 1 trials with AP30663, with treatment being well tolerated and no serious adverse events reported between groups. bottom. Ventricular arrhythmias, the main safety concern of available atrial fibrillation treatments, were not evident throughout the trial.

John Cam, Emeritus Professor of Clinical Cardiology at St George’s University, London, said: By treating them with antiarrhythmic drugs. This new mechanism has the potential to realize these aspects. “

Acesion CEO Anders Gaarsdal Holst concludes: Further de-risking a pipeline of small molecule SK inhibitors including AP31969. This is an ongoing second-generation oral lead program targeting the broader chronic therapeutic indication of sinus rhythm maintenance. “

Acesion is currently pursuing an oral SK channel inhibitor program for chronic maintenance therapy to prevent recurrence of atrial fibrillation. The condition is projected to affect her 24 million people in the US and her EU by 2030.

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