Theravance Biopharma Announces Peer-Reviewed Publication Highlighting TD-1473 Program in the Journal of Crohn's and Colitis
TD-1473 is a novel, gut-selective oral pan-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 gut-selective -- specifically designed to act locally at the site of inflammation in the intestinal wall with limited systemic exposure. TD-1473, which is the focus of a global co-development and commercialization agreement with
The published manuscript, authored by
Phase 1b Clinical Study Results for TD-1473 (40 patients):
- Signals of clinical, histologic and biomarker activity following four weeks of treatment versus placebo, suggesting achievement of localized target engagement in patients with moderately-to-severely active ulcerative colitis
- Minimal systemic exposures and no evidence of systemic immunosuppression or systemic opportunistic infections
Phase 1 Clinical Study Results for TD-1473 (72 subjects):
- Generally well tolerated in healthy subjects as a single dose (up to 1000 mg) and as a daily dose (up to 300 mg) given for 14 days
- Low plasma exposure and high stool concentrations at a range of doses, supporting gut-selective properties
Preclinical Study Results for TD-1473:
- Demonstrated potent inhibition of JAK inflammatory activity
- Gut selectivity, as evidenced by high drug concentrations in colon with minimal plasma drug exposure
- Efficacy in a colitis mouse model, as evidenced by significantly reduced colitis manifestations
"This manuscript offers the most comprehensive collection of data from our ongoing TD-1473 program to date, highlighting the potentially transformational nature of our organ-selective JAK inhibition approach in treating inflammatory intestinal diseases such as ulcerative colitis and Crohn's disease. This compilation of data from preclinical and clinical studies paints a consistent and encouraging picture of TD-1473 in the areas of minimized systemic exposure, localized target engagement and potential to reduce disease activity," said
The peer-reviewed manuscript in the
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.
Theravance Biopharma, Inc. ("
Our purpose is to create transformational medicines to improve the lives of patients suffering from serious illnesses. Our research is focused in the areas of inflammation and immunology.
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 FDA-approved YUPELRI® (revefenacin) inhalation solution indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Our pipeline of internally discovered programs is targeted to address significant patient needs.
We have an economic interest in potential future payments from Glaxo Group Limited or one of its affiliates (GSK) pursuant to its agreements with Innoviva, Inc. relating to certain programs, including TRELEGY ELLIPTA.
For more information, please visit www.theravance.com.
THERAVANCE® and the Cross/Star logo are registered trademarks of the
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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