Acesion Pharma Announces Positive Pre-Clinical Data for AP31969

Copenhagen, Denmark, 15 May 2023 – Acesion Pharma (“Acesion” or “the Company”), a biotech company pioneering first-in-class novel therapies for atrial fibrillation (“AF”), the most common cardiac arrhythmia, today announces positive data from pre-clinical studies with AP31969, its second-generation oral SK channel inhibitor developed for chronic oral maintenance treatment to prevent AF recurrence.

Acesion aims to develop a novel drug for AF that solves the major concern with existing drugs; a high-risk of life-threatening cardiac arrhythmia, also known as proarrhythmia.

To refine drug proarrhythmia risk prediction; regulators, academics, and industry have collaborated on developing pre-clinical models with this specific purpose. In two such models, AP31969 has demonstrated a low risk of proarrhythmia with robust differentiation to existing drugs, which have a high risk of proarrhythmia, tested in the same models. Further results from pre-clinical studies showed that AP31969, tested at expected supratherapeutic doses across two in-vivo large animal models, has no prolongations of the corrected QT interval, a well-established marker of proarrhythmia risk.

In addition to its promising cardiac safety profile, AP31969 has demonstrated good oral pharmacokinetic properties across different animal species and a low-risk of causing drug-drug interactions, another significant issue with existing drugs.

AP30663, Acesion’s first-in-class SK ion channel inhibitor for conversion of AF to normal sinus rhythm, recently demonstrated robust efficacy in patients with AF. AP31969 has shown strong and similar efficacy to AP30663 in two animal models, supporting that efficacy can be expected to be shared across the two compounds.

Finally, AP31969 has recently completed the toxicology studies required by regulatory authorities, ahead of the phase 1 trial which Acesion plans to start in H2 2023.

Anders Gaarsdal Holst, MD, PhD, Chief Executive Officer of Acesion, said "With a growing number of patients suffering from atrial fibrillation, there is a significant need for treatment. 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 1 clinical trial and look forward to the continued progress we will make in the coming year."

Pre-clinical studies have shown pronounced antiarrhythmic effects in the atria while avoiding effects on the ventricles, the major chambers of the heart and the source of most safety issues with existing drugs, when inhibiting the SK channels. Further, the SK channel has strong genetic validation with genes encoding the SK channels having one of the strongest associations to AF in human genome-wide association studies.