Theravance Biopharma Announces Data from Phase 1b Study of TD-1473 Selected for Oral Late-Breaker Presentation at UEG Week 2018
TD-1473 is a novel, potent, orally administered and gut selective pan-Janus kinase (JAK) inhibitor in clinical development with the potential to treat a range of inflammatory intestinal diseases, including ulcerative colitis and Crohn's disease. 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 thereby limiting systemic exposure.
Details of the oral late-breaker presentation are as follows:
- Title: The Intestinally Restricted, Orally Administered, Pan-JAK Inhibitor TD-1473 Demonstrates Favorable Safety, Tolerability, Pharmacokinetics, and Signal for Clinical Activity in Subjects with Moderately-to-Severely Active Ulcerative Colitis
- Publication Number: LB05
- Presentation Type: Oral Late-Breaker
- Presenting Author: Julian Panés, M.D.
- Session: Clinical Trials in IBD
- Session Date/Time:
Monday, October 22, 2018, 2:00 – 3:30 PM(local time)
- Presentation Location: Room C
As previously reported, top-line results from this Phase 1b clinical trial of TD-1473 demonstrated localized biological activity and minimal systemic exposure, as well as a favorable safety and tolerability profile.
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 an oral, 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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