Danish pharmaceutical firm Acesion Pharma has reported positive pre-clinical data for its second-generation oral SK channel inhibitor AP31969.
AP31969 is intended to be a chronic oral maintenance treatment to prevent atrial fibrillation (AF) recurrence, which can lead to the high-risk, life-threatening cardiac arrhythmia known as proarrhythmia.
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The drug has demonstrated a low risk of proarrhythmia with robust differentiation compared with existing drugs when tested in two preclinical models.
Further preclinical studies have shown that AP31969 has no prolongations of the corrected QT interval, an established proarrhythmia risk marker, when tested across two in-vivo large animal models.
AP31969 has also demonstrated a low risk of causing drug-on-drug interactions and exhibited good oral pharmacokinetics across various animal species.
In addition, preclinical studies have shown that the drug causes pronounced antiarrhythmic effects in the atria while avoiding effects on the ventricles.
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By GlobalDataAcesion CEO Anders Gaarsdal Holst said: “Unfortunately, all existing drugs have major safety issues that endanger patients.
“Acesion’s positive pre-clinical results support that AP31969 has the potential to solve these issues and greatly broaden the use of pharmacological treatment within atrial fibrillation.
“We are excited to continue the development of AP31969 with a Phase I clinical trial and look forward to the continued progress we will make in the coming year.”
Acesion has also completed toxicology studies of AP31969 required by the regulatory authorities for Phase I trial initiation, which is planned for the second half of this year.
Based in Copenhagen, the firm claims to be the only company able to identify and progress SK channel inhibitors into clinical trials.
Earlier this year, it reported positive data from a Phase II trial of AP30663, a first-in-class SK ion channel inhibitor for conversion of AF to normal sinus rhythm.
AP30663’s safety profile in the trial was consistent with that observed in two previous Phase I trials of the drug.
