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Xention and Servier commence first phase 2 study of XEN-D0103/S66913 in atrial fibrillation01/09/2014
CAMBRIDGE, UK 1 September 2014 – XENTION LTD ("Xention"), the Cambridge-based biopharmaceutical company specialising in the discovery and development of ion channel-modulating anti-arrhythmic drugs, announced today that the phase 2 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/S66913, 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/S66913 have been retained by Xention, while Servier has commercialization rights in all other territories of the world. Servier and Xention are undertaking a joint programme of clinical development for XEN-D0103/S66913, including two phase 2 clinical studies aimed at demonstrating the efficacy of the compound in AF.
The first of the planned Phase 2 studies is being managed by Xention and is designed to assess the efficacy and safety of XEN-D0103/S66913 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, randomized, placebo-controlled, crossover trial in a total of twenty 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/S66913 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/S66913 is being evaluated in the first of two planned studies in AF".
Dr Isabelle Tupinon-Mathieu, Vice President Research and Development 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 being approved by the competent authorities and should start in a 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.
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Notes to Editors
About Xention Ltd
Xention is a leader in the discovery and development of ion channel-modulating drugs. The Company is developing a pipeline of innovative products for the treatment of atrial fibrillation, an indication for which there is high unmet medical need, by targeting key ion channels. Xention uses an innovative approach to discover and design potent and selective small-molecule drugs and has collaborations with several companies. In atrial fibrillation, the company is developing modulators of Kv1.5 and Kir3.1/3.4 (IKACh), both recognised as novel, highly exciting new targets for the disease. Its Kv1.5 programme is the subject of a partnership with Servier for all territories except the US and Japan. For further information, please see http://www.xention.com.
Founded in 1954, Servier is an independent French pharmaceutical research company. Its development is based on the continuous pursuit of innovation in the therapeutic areas of cardiovascular, metabolic, neurologic, psychiatric, bone and joint diseases as well as cancer. In 2013, the company recorded a turnover of 4.2 billion euros. 91% of Servier drugs are consumed outside France. 27% of turnover from Servier drugs were reinvested in Research and Development in 2013. With a strong international presence in 140 countries, Servier employs more than 21 000 people worldwide. The Servier Group contributed 35% to the 2013 French trade surplus in the pharmaceuticals sector.
About atrial fibrillation
Atrial fibrillation (AF) is the most common sustained cardiac rhythm disturbance, occurring in between 1 and 2 per cent of the general population but increasing rapidly with age. It is estimated that over six million Europeans suffer from this arrhythmia and its prevalence is calculated to increase by at least 2.5 fold in the next 50 years as the population ages. AF confers a five-fold increased risk of stroke and one in five of all strokes are attributable to AF. The ischemic strokes seen in association with the arrhythmia are often fatal, and those that survive are often left crippled by their stroke and likely to suffer recurrent strokes. Around one per cent of the healthcare budget of Western European and North American countries is spent on the management of AF. Thus this disease presents a rapidly growing social, medical and public health problem in need of urgent solution.