Ario Pharma has commenced a Phase IIa study of its oral TRPV1 antagonist, XEN-D0501, for the treatment and prevention of cough in patients with chronic idiopathic cough (CIC).
Approximately 20 patients will be enrolled into the study, which is being led by Professor Jacky Smith (principal investigator), University of Manchester and University Hospital Manchester NHS Foundation Trust, and Dr Lorcan McGarvey, clinical senior lecturer, Queens University and Belfast City Hospital, Belfast. Patients with CIC 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 Professor Jacky Smith.
Dr John Ford, CEO of Ario Pharma, commented: “Patients with CIC have a heightened cough reflex, which means that their cough is triggered by minor environmental stimuli that would not normally evoke coughing. This neuronal hypersensitivity is mediated through TRPV1 and because XEN-D0501 selectively inhibits TRPV1 it is expected to prevent coughing in this patient group. The study announced today is being conducted in parallel with a second study of XEN-D0501 in patients with cough associated with chronic obstructive pulmonary disease, which is already under way.”
Jacky Smith commented: “It is often not appreciated that chronic cough can be a severe problem, ruining sufferers’ lives. These patients may cough between hundreds and thousands of times per day, and treatment options are extremely limited.”