Theravance Biopharma Announces First Patient Dosed in Phase 2 Study of TD-1473 in Patients with Crohn's Disease
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
About Gut-Selective Pan-Janus (JAK) Kinase Inhibition
JAK inhibitors function by inhibiting the activity of one or more of the Janus kinase family of enzymes (JAK1, JAK2, JAK3, TYK2) that play a key role in cytokine signaling. Inhibiting these JAK enzymes interferes with the JAK/STAT signaling pathway and, in turn, modulates the activity of a wide range of pro-inflammatory cytokines. JAK inhibitors are currently approved for the treatment of diseases such as rheumatoid arthritis and myelofibrosis, and have demonstrated therapeutic benefit for patients with ulcerative colitis. However, these products are known to have side effects associated with their systemic exposure.
TD-1473 is an internally-discovered JAK inhibitor that has demonstrated a high affinity for each of the JAK family of enzymes. Importantly, TD-1473 is a gut-selective treatment specifically designed to distribute adequately and predominantly to the tissues of the intestinal tract, treating inflammation in those tissues while minimizing its systemic exposure.
In our relentless pursuit of this objective, we strive to apply insight and innovation at each stage of our business, including research, development and commercialization, and utilize both internal capabilities and those of partners around the world. Our research efforts are focused in the areas of inflammation and immunology. Our research goal is to design localized medicines that target diseased tissues, without systemic exposure, in order to maximize patient benefit and minimize risk. These efforts leverage years of experience in developing localized medicines for the lungs to treat respiratory disease. The first potential medicine to emerge from our research focus on immunology and localized treatments is an oral, gut-selective pan-Janus kinase (JAK) inhibitor, currently in development to treat a range of inflammatory intestinal diseases. Our pipeline of internally discovered product candidates will continue to evolve with the goal of creating transformational medicines to address the significant needs of patients.
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