Theravance Biopharma Announces First Patient Dosed in Phase 2b/3 Study of TD-1473 in Patients with Ulcerative Colitis
The Phase 2b/3 study will utilize a multi-center, randomized, double-blind, multi-dose, placebo-controlled, parallel-group design to evaluate the efficacy, safety and tolerability of induction and maintenance therapy with TD-1473 in patients with moderately to severely active ulcerative colitis. The Phase 2b dose-finding induction portion of the study will assess the effect of eight weeks of treatment with select once-daily doses of TD-1473 on change from baseline in total Mayo score as the primary endpoint and will also assess rates of clinical response and remission, endoscopic mucosal healing, safety and tolerability. Based on efficacy, safety and tolerability findings from the dose-finding portion of the study, one or more doses of TD-1473 will be selected and evaluated in the Phase 3 induction portion of the study, with the primary objectives of assessing clinical remission rates with TD-1473 compared to placebo at Week 8 and safety and tolerability of TD-1473.
Patients who achieve clinical responses during the induction stage of the study, either from the Phase 2b or Phase 3 portion of the study, will then be immediately enrolled in the Phase 3 maintenance portion of the study. Patients will be randomized to receive placebo or one of two doses of TD-1473 for 44 weeks. The primary objectives of the maintenance study are to assess the clinical remission rates for TD-1473 as compared to placebo after 44 weeks, as well as safety and tolerability of TD-1473.
"The initiation of our Phase 2b/3 study of TD-1473 in ulcerative colitis follows the previously-announced initiation of a Phase 2 study in patients with Crohn's disease. The breadth of our TD-1473 clinical development efforts reflects our confidence in the potential therapeutic benefit of our unique gut-selective JAK inhibitor," 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, myelofibrosis, and 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 pursuit of our purpose, we apply insights and innovation at each stage of our business and utilize our internal capabilities and those of partners around the world. We apply organ-selective expertise to biologically compelling targets to discover and develop medicines designed to treat underserved localized diseases and to limit systemic exposure, in order to maximize patient benefit and minimize risk. These efforts leverage years of experience in developing lung-selective medicines to treat respiratory disease, including
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This press release contains certain "forward-looking" statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives, expectations and future events. Theravance Biopharma intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. Examples of such statements include statements relating to: the Company's strategies, plans and objectives, the Company's regulatory strategies and timing of clinical studies (including the data therefrom), the potential characteristics, benefits and mechanisms of action of the Company's product and product candidates, and the Company's expectations for product candidates through development and potential regulatory approval and commercialization (including their potential as components of combination therapies and their differentiation from other products or potential products). These statements are based on the current estimates and assumptions of the management of
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