Xention Reports Positive Phase 1 Data for New Atrial Fibrillation Drug
Xention Ltd. reported positive data today from a phase 1 trial of XEN-D0103 administered orally. The drug, a selective inhibitor of the cardiac potassium channel Kv1.5, was well tolerated and demonstrated good pharmacokinetic (PK) properties. The results support the continuing development of XEN-D0103 for the treatment of atrial fibrillation (AF), a commonly encountered and potentially serious cardiac arrhythmia in which the atria of the heart beat in a rapid and irregular manner, resulting in reduced cardiac output and increased risk of stroke.
The phase 1 clinical trial, which was conducted in the UK, studied single and multiple ascending oral doses of XEN-D0103 in healthy volunteer subjects in three parts. The study evaluated the safety and pharmacokinetics of various doses and also the effects of food. XEN-D0103 was well tolerated with a good PK profile and no significant food, gender or age related effects were observed. No significant adverse events were reported.
Importantly, a detailed ECG (electrocardiogram) analysis of data collected from the first cohort of 30 healthy volunteers indicated that XEN-D0103 had no effect on the QTcF interval. This absence of any detectable effect on QTcF, confirming the atrial selectivity of XEN-D0103, is an important safety attribute for a new atrial fibrillation drug, since many current antiarrhythmic drugs can lead to significant QT-interval prolongation and further arrhythmia problems.
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