Copenhagen, Denmark – 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.
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For additional information please contact:
Anders Gaarsdal Holst, MD, PhD, Chief Executive Officer
Tel: +45 5240 5266
Optimum Strategic Communications
Mary Clark, Nick Bastin, Hana Malik
Nick Bastin – +44 (0) 79 3150 0066
Hana Malik – +44 (0) 78 5228 8062
About Acesion Pharma
Acesion builds on 20 years of know-how with development of small-molecule SK inhibitors and is the world leader in the field of SK channel inhibition, being the only company able to identify and progress SK channel inhibitors into clinical trials. In pre-clinical studies, inhibiting the SK channels has been shown to result in 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. Furthermore, 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. Acesion’s AP30663 IV is a short acting conversion therapy for hospitals that has completed a phase 2 trial proving the value of this first-in-class mechanism in AF and thereby de-risking Acesion’s broader SK inhibitor pipeline. Acesion’s oral program is designed and engineered using in house knowhow to optimise for, and meet, very high hurdles in both efficacy and particularly safety where existing treatments fall short of patient needs. Acesion Pharma is backed by Novo Holdings A/S, Wellcome Trust, Broadview Ventures and FC Capital.
About atrial fibrillation (AF)
AF is the most common type of cardiac arrhythmia mainly affecting the elderly population. Lifetime risk for development of AF is estimated at more than one in three. It is forecast to affect 25 million people in the US and EU by 2030. AF is characterized by chaotic electrical activity in the upper chambers of the heart, the atria, resulting in an irregular and high heart rate. AF is associated with impaired quality of life, increased rate of hospitalization, and a five-fold increased risk of stroke. Increasing evidence suggests that patients with AF also face a higher risk of cognitive dysfunction and dementia.
AF is often treated by electrical shock to bring the heart back to its normal rhythm
(conversion). This requires general anesthesia in a hospital setting. In addition, many patients are likely to benefit from chronic treatment to prevent AF and maintain normal sinus rhythm. Existing drug therapies for cardioversion or prevention of AF are associated with risk of serious cardiac or other adverse effects, resulting in a great need for safer drugs. Yet, there has been a lack of innovation and development with no new chronic AF drug approved for nearly 20 years. A landmark New England Journal of Medicine published clinical trial (https://doi.org/10.1056/NEJMoa2019422) has shown that sinus rhythm maintenance treatment improves survival and long-term outcomes for AF patients.