First Patient Dosed in Phase 2b/3 Study of TD-1473 for Ulcerative Colitis

First Patient Dosed in Phase 2b/3 Study of TD-1473 for Ulcerative Colitis
Theravance Biopharma announced that the first patient has been dosed in a Phase 2b/3 study to test the efficacy and safety of its candidate oral drug TD-1473 for the treatment of moderate to severe active ulcerative colitis. The Phase 2b/3 clinical trial (NCT03758443) is still recruiting participants. TD-1473 is a novel oral drug that selectively inhibits the Janus kinase (JAK) family of enzymes. The drug blocks JAK signaling pathways involved in the spread of inflammatory signals, namely those triggered by immune messengers, referred to as cytokines. Contrary to other JAK inhibitors approved for IBD and other illnesses, TD-1473 was designed to act predominantly in the gastrointestinal tract, thus overcoming potential side effects due to a generalized, or systemic, exposure to the drug. An early exploratory study sponsored by Theravance has yielded encouraging results for the use of TD-1473 for people with ulcerative colitis. Now, the company initiated a Phase 2b/3 clinical trial (NCT03758443) to evaluate the efficacy, safety and dose tolerability of TD-1473, given as an initial therapy and a maintenance treatment for moderate to severe active ulcerative colitis. The study is a randomized, double-blind, placebo-control trial being conducted at centers across the U.S. In the first part of the study (phase 2b induction), patients will be randomly assigned to one of four groups, one having placebo and the other three each having a different dose of TD-1473 per day over eight weeks. Based on the efficacy and safety results obtained in this part, one or more doses of TD-1473 will be selected for the second part of the study (phase 3 induction), meant to evaluate the target doses as a primary treatment of eight weeks. The primary outcome measure
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