Ario Pharma Ltd, the Cambridge biopharmaceutical company developing innovative new approaches to treat respiratory disease, announced today that it has commenced a Phase IIa study of its TRPV1 antagonist, XEN-0501, for the treatment and prevention of cough in patients with chronic obstructive pulmonary disease (COPD). Persistent cough in COPD and other respiratory conditions present as a huge unmet medical need, with novel therapies urgently needed to improve the quality of life of patients.
The study is led by Dr Jacky Smith, Reader and Honorary Consultant in Respiratory Medicine (Principal Investigator) and Professor Dave Singh, Professor of Clinical Pharmacology and Respiratory Medicine (Co-investigator), both based at the University of Manchester. The study is being conducted at the Medicines Evaluation Unit Ltd, University Hospital Manchester NHS Foundation Trust, Manchester. Patients with COPD associated with a history of persistent coughing will be assigned to receive XEN-D0501 or a placebo in a randomised, double-blinded, cross-over study.
XEN-D0501, a potent and selective small molecule inhibitor of TRPV1, has successfully completed multiple Phase I studies and been shown to be safe and well tolerated. The frequency of coughing will be assessed in treatment and placebo groups throughout the study using validated ambulatory cough monitoring technology developed by Dr Jacky Smith. Approximately 22 patients are anticipated to be enrolled into the study and initial results are expected to be analysed and available for release during Q3 2014.