Theravance Reports Positive Phase 1 Data on TD-1473, a JAK Inhibitor for IBD

Theravance Reports Positive Phase 1 Data on TD-1473, a JAK Inhibitor for IBD
Theravance Biopharma, Inc., recently reported positive data from its Phase 1 clinical trial assessing TD-1473, a new and oral pan-Janus kinase (JAK) inhibitor designed to enter the gastrointestinal tract and target inflammation without significant systemic exposure. Proinflammatory cytokines play an important role in inflammatory bowel disease (IBD), many of which signal via the JAK/signal transducer and activator of transcription (STAT) pathway. The study was a placebo-controlled, randomized, single ascending dose (SAD) and multiple ascending dose (MAD) Phase 1 trial (NCT02657122) assessing TD-1473 in healthy subjects. Its primary objective was to evaluate the safety and tolerability of TD-1473 SAD and MAD in participants, and a key secondary objective was to characterize pharmacokinetics related to TD-1473, to help determine the amount of drug that enters systemic circulation following oral dosing. The drug is being developed to treat IBDs, including ulcerative colitis. Results showed that treatment with TD-1473 is safe and well-tolerated as a single dose (up to 1000 mg), and as a daily dose (up to 300 mg) given for 14 days, without causing serious adverse reactions. In terms of systemic circulation, the results demonstrated that TD-1473 exposures were low relative to that seen for tofacitinib, a JAK inhibitor recently tested in Phase 3 trials as a potential ulcerative colitis treatment. Compared to the plasma exposure of tofacitinib at twice daily doses of 10 mg, the plasma exposures of TD-1473 at daily doses of 30 mg and 100 mg were about 75-fold and 15-fold lower, respectively, Theravance reported in a
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