Date: 2012-03-20
Type of information: Results
phase: 1
Announcement: results
Company: Xention (UK)
Product: XEN-D0103
Action
mechanism: XEN-D0103 blocks the atrial specific Kv1.5 potassium channel in the heart and is one of the first such selective drugs to reach the clinic.
Disease: treatment and prevention of atrial fibrillation
Therapeutic area: Cardiovascular diseases
Country: UK
Trial
details: The clinical trial is a combined single- and multiple-ascending oral dose study of XEN-D0103 in healthy volunteer subjects being conducted in the UK. The study will evaluate the safety and pharmacokinetics of various dosages of the new medicine prior to phase 2a efficacy studies, expected to commence in 2012.
Latest
news: * On March 20, 2012, Xention a Cambridge-based biopharmaceutical company specialising in the discovery and development of ion channel-modulating drugs, has reported positive data 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 anddemonstrated good pharmacokinetic (PK) properties. The results support the continuing development of XEN-D0103 for the treatment of atrial fibrillation. The phase 1 clinical trial, which was conducted in the UK, studied single and multipleascending 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.
* On July 27, 2011, Xention has initiated phase 1 clinical development of XEN-D0103. The company looks forward to reporting the results of this study early in 2012.
