The biotech company is aiming 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 and academics 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, 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.
According to Acesion, AP30663 has seen robust efficacy in patients with AF, while AP31969 has shown strong and similar efficacy to AP30663 in two animal models.
In addition, 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.
"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,” said Anders Gaarsdal, chief executive officer of Acesion.
“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."