Additional Relevant Details
The Phase 1b trial is a multi-center, randomized, double-blind, multi-dose, placebo-controlled study in 40 patients with moderate to severe ulcerative colitis. Patients will be randomized to receive one of three doses of TD-1473 or placebo for 28 days in sequential fashion. The primary objectives of the study will include evaluation of the safety and tolerability of TD-1473 administered for 28 days, as well as assessment of the compound's plasma exposure following administration. A key secondary objective of the trial will be the evaluation of the effect of TD-1473 on levels of a range of key ulcerative colitis biomarkers, including C-reactive protein (CRP) and fecal calprotectin (FC). Additionally, investigators will evaluate a number of exploratory objectives, including changes in partial Mayo score and improvement in disease activity through endoscopic and histologic assessments. The Company expects data from the Phase 1b trial to be available in mid-2017.Theravance Biopharma recently announced positive results from a Phase 1 clinical trial of TD-1473 in healthy volunteers demonstrating the compound to be generally well tolerated as a single dose (up to 1000 mg) and as a daily dose (up to 300 mg) given for 14 days. There were no serious adverse events and the only adverse events reported in subjects dosed with TD-1473 were considered mild in severity and short in duration, with none leading to study discontinuation. Furthermore, findings from the Phase 1 trial related to systemic exposure and stool concentrations of TD-1473 support the Company's perspective that a therapeutically relevant level of TD-1473 can be delivered to and penetrate the colon wall with minimal release into the systemic circulation.