Ario Pharma Ltd has announced 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 randomized, 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 analyzed and available for release during Q3 2014.
Ario Pharma also announces Professor Maria Belvisi from the National Heart and Lung Institute, Imperial College London, has been appointed as Chief Scientific Officer. Professor Belvisi is an internationally recognized expert in the respiratory field with both pharmaceutical industry and academic research experience. She has received numerous honours and awards for her research into the cellular and molecular mechanisms of asthma, COPD and cough.
Dr John Ford, CEO of Ario Pharma, commented: “Heightened sensitivity of pulmonary TRPV1 channels in COPD is well known, but this is the first time an oral TRPV1 inhibitor has been tested for efficacy in preventing cough in COPD patients. We are very pleased to begin evaluation of XEN-D0501 in patients. We are also delighted to welcome Maria Belvisi as Chief Scientific Officer. Maria is already a member of Ario Pharma’s Scientific Advisory Board, and in her new role will become more deeply involved with the company.”