Date: 2014-07-09
Type of information: Initiation of the trial
phase: 2a
Announcement: initiation of the trial
Company: Ario Pharma (UK)
Product: XEN-D0501
Action
mechanism: XEN-D0501 is a Phase 2 ready drug that inhibits TRPV1, an ion channel known to play a pivotal role in controlling airway vagal sensory nerve activation and the cough reflex. In preclinical studies, XEN-D0501 suppressed ex vivo vagal nerve firing in response to tussive agents and cough counts in animal models. There is substantial published clinical evidence for the role of TRPV1 in the pathogenesis of cough, which suggests that TRPV1 antagonists could inhibit chronic cough in both idiopathic cough and COPD cough (Khalid et al. 2011). XEN-D0501 has demonstrated good oral bioavailability and appropriate pharmacokinetics and been remarkably well tolerated in both healthy volunteers (Round et al. 2011) and patients.
Disease: chronic idiopathic cough (CIC)
Therapeutic area: Respiratory diseases - Inflammatory diseases
Country: UK
Trial details:
Latest
news: * On July 9, 2014, Ario Pharma, a biopharmaceutical company developing innovative new treatments for respiratory disease, announced today that it 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.
