Date: 2014-02-11
Type of information: Initiation of the trial
phase: 2a
Announcement: initiation of the study
Company: Ario Pharma (UK)
Product: XEN-0501
Action
mechanism: XEN-0501 is a selective small molecule TRPV1 antagonist. TRPV1 (transient receptor potential channel V1) is a non selective cation channel that is permeable to Na+, K+, Ca2+ and Mg2+. This cation channel is a key molecule in pain. It can be activated by several noxious stimuli including chemicals in the vanilloid class (eg, capsaicin and resiniferatoxin), elevated temperatures and protons. TRPV1 is highly expressed in sensory neurons, but has also been detected in numerous other tissues including the brain, pancreas, kidney and liver.
Disease: cough associated with chronic obstructive pulmonary disease (COPD)
Therapeutic area: Respiratory diseases - Inflammatory diseases
Country: UK
Trial
details: 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.
Latest
news: * On February 11, 2014, Ario Pharma, a Cambridge biopharmaceutical company developing innovative new approaches to treat respiratory disease, 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). XEN-D0501 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.
