Xention has announced that the phase II development of its lead atrial fibrillation programme (AF) is underway.
In 2013, Xention entered into an agreement with Servier for the development and commercialisation of XEN-D0103, a potent and selective oral modulator of the cardiac potassium channel Kv1.5, which was discovered and developed by Xention for the treatment of AF. Under the terms of the agreement, US and Japanese rights to XEN-D0103 have been retained by Xention, while Servier has commercialisation rights in all other territories of the world. Servier and Xention are undertaking a joint programme of clinical development for XEN-D0103, including two phase II clinical studies aimed at demonstrating the efficacy of the compound in AF.
The first of the planned phase II studies (the 'XAPAF' study) is being managed by Xention and is designed to assess the efficacy and safety of XEN-D0103 in patients with paroxysmal AF. The study is being undertaken at Eastbourne General Hospital with Dr Neil Sulke as Principal Investigator. The design is a double-blind, randomised, placebo-controlled, crossover trial in a total of 20 patients suffering from paroxysmal AF who also have implanted pacemakers, enabling continuous beat-to-beat monitoring of drug efficacy.
Commenting on the study, Dr Sulke said: "XEN-D0103 is a potent and selective blocker of the potassium channel Kv1.5, and this is the first time a highly selective Kv1.5 blocker is being assessed in patients with AF."
Tim Brears, CEO of Xention said: "We are delighted to report that our partnership with Servier is progressing extremely well and that XEN-D0103 is being evaluated in the first of two planned studies in AF."
Dr Isabelle Tupinon-Mathieu, vice president R&D and head of cardiovascular and metabolism therapeutic innovation departments at Servier said: "We are pleased to announce that the second study 'DIAGRAF-IKur', managed by Servier, is in the process of being approved by the competent authorities and should start in the near future.”
In addition to its Kv1.5 programme, Xention is also developing antagonists of Kir3.1/3.4 (IKACh), a second exciting target for AF. Both Kv1.5 and Kir3.1/3.4 (IKACh) are expressed only in the atria and represent exciting targets for the development of atrial-selective therapeutics for the treatment of AF.