A Study Evaluating the Efficacy and Safety of AP30663 for Cardioversion in Participants With Atrial Fibrillation (AF)

Phase 2 Completed 66 enrolled Acesion Pharma

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study will evaluate the efficacy, safety, tolerability and pharmacokinetics (PK) of one or more doses of AP30663 for cardioversion in adult participants with AF.

Timeline

Start: 2019-09-09
Primary completion: 2022-12-13
Completion: 2023-01-23

Outcome

Met primary endpoint

paper Both doses demonstrated more than 99.9% probability of superiority over placebo, surpassing the prespecified 95% threshold. PMID 38092897 ↗

release “AP30663 achieved proof of mechanism with first-in-class SK channel inhibition compound in atrial fibrillation – primary endpoint met:” acesionpharma.com ↗

Publications

Holst AG, Tomcsanyi J, Vestbjerg B, Grunnet M, Sorensen US, Diness JG, Bentzen BH, Edvardsson N, Hohnloser SH, Bhatt DL, Dorian P. Inhibition of the KCa2 potassium channel in atrial fibrillation: a randomized phase 2 trial. Nat Med. 2024 Jan;30(1):106-111. doi: 10.1038/s41591-023-02679-9. Epub 2023 Dec 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	AP30663	Unknown	3 mg/kg	Intravenous
Subject	AP30663	Unknown	5 mg/kg	Intravenous