Theravance Biopharma reports 'positive' data on TD-1473 at ECCO
Theravance Biopharma announced the presentation of positive clinical data for TD-1473, a novel, potent, and orally administered pan-Janus kinase inhibitor designed to be intestinally restricted, at the 12th Congress of the European Crohn's and Colitis Organization. In a poster presentation, the Company reported further data from its completed Phase 1 study of single-ascending and multiple-ascending doses of TD-1473. Results of the study were first announced in June 2016. Theravance Biopharma is developing TD-1473 as an investigational compound with the potential to treat a range of inflammatory intestinal diseases and is currently conducting a Phase 1b study of the compound in patients with moderate to severe ulcerative colitis. The findings presented at ECCO reaffirm previously announced results from the Phase 1 study which demonstrated TD-1473 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. Newly presented data demonstrated that no moderate, severe or serious treatment emergent adverse events were reported in subjects dosed with TD-1473, and no TEAEs of any severity led to study discontinuation. TEAEs were higher in subjects receiving placebo than in subjects receiving TD-1473 in both the single-ascending and multiple-ascending dose portions of the study. Additionally, the study data presented demonstrated that TD-1473 exhibited a pharmacokinetic profile consistent with the Company's goal of designing the compound to penetrate the intestinal wall from within and act directly at the site of inflammation with minimal systemic exposure. Across a range of doses, the observed systemic concentrations of TD-1473 were consistent with low bioavailability and intestinal restriction. For all doses in both the single-ascending and multiple-ascending groups, the amount of TD-1473 that was excreted in the urine was less than 0.5% of the administered dose. TD-1473 is designed to be intestinally restricted, which potentially represents a key competitive advantage for the compound based on the range of safety and tolerability concerns associated with systemically available JAK inhibitors.