Clinical Trial of Potential Ulcerative Colitis Treatment Enters Next Phase

Clinical Trial of Potential Ulcerative Colitis Treatment Enters Next Phase
Theravance Biopharma announced the first dosing of a patient with moderate to severe ulcerative colitis  enrolled in its Phase 1b clinical trial, which is evaluating the investigational drug TD-1473, a pan-Janus kinase (JAK) inhibitor with the potential to treat a range of inflammatory intestinal diseases.  The clinical trial is recruiting patients. Proinflammatory cytokines play an important role in inflammatory intestinal diseases, many of which signal via the JAK/signal transducer and activator of transcription (STAT) pathway. TD-1473, a novel pan-JAK inhibitor, was designed to inhibit JAK in the gastrointestinal tract upon oral dosing without significant systemic exposure. The 28-day, multi-center, randomized, double-blind, placebo-controlled study (NCT02818686) is examining the safety, tolerability, pharmacokinetics, and pharmacodynamics of TD-1473 in patients with moderate-to-severely active ulcerative colitis UC. Forty enrolled patients with UC will be assigned randomly to receive either one of three doses of TD-1473 or a placebo for 28 days. The trial’s primary goal is the assessment of safety and tolerability through examination of adverse events, and the evaluation of TD-1473's plasma exposure following administration. The trial also will explore the biologic effect associated with TD-1473 through biomarker analysis a
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