Theravance Biopharma Announces First Patient Dosed in TD-1473 Study

Theravance Biopharma announced dosing of the first patient in a Phase 2 clinical trial of TD-1473 in patients with Crohn's disease. TD-1473 is a novel, potent, orally administered and gut-selective pan-Janus kinase (JAK) inhibitor in development as a treatment for multiple inflammatory intestinal diseases. In contrast to other oral JAK inhibitors under development for inflammatory bowel disease, TD-1473 is specifically designed to act locally at the site of inflammation in the intestinal wall with minimal systemic exposure.

The Phase 2 study is a multi-center, randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy, safety and tolerability of TD-1473 in approximately 160 patients with moderately to severely active Crohn's disease. Patients will be randomized to receive one of two active doses of TD-1473 or placebo once daily for up to 12 weeks. The primary endpoint of the study is improvement in Crohn's Disease Activity Index (CDAI) score measured at 12 weeks. The study also includes an active treatment extension phase that will include those patients who complete the 12-week induction phase.

"We are excited to advance our gut-selective JAK inhibitor program into its first Phase 2 trial as we believe TD-1473 can produce potentially transformative therapeutic activity against inflammatory intestinal diseases. Clinical data generated to date provide us with confidence as we begin a comprehensive late-stage development program for TD-1473, encompassing this study in Crohn's disease and an upcoming Phase 2b/3 trial in patients with ulcerative colitis," said Brett Haumann, MD, Chief Medical Officer at Theravance Biopharma. "We are hopeful that findings from these trials will demonstrate desired therapeutic results in these indications with an acceptable safety profile, and further confirm the localization of biological activity within the intestine with minimal systemic exposure."

Theravance Biopharma previously announced positive results from a Phase 1b clinical trial of TD-1473 in 40 patients with ulcerative colitis, demonstrating localized biological activity and minimal systemic exposure, as well as a favorable safety and tolerability profile. These results formed the basis for progressing TD-1473 into larger clinical trials in Crohn's disease and ulcerative colitis. Based on these positive Phase 1b data and successful dialogues with U.S. Food and Drug Administration (FDA) and European Medicines Authority (EMA) regarding the late-stage development plan, Theravance Biopharma also plans to initiate a Phase 2b/3 induction and maintenance study of TD-1473 in patients with ulcerative colitis in late 2018 or early 2019.

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