Theravance Biopharma Submits IBD Drug for FDA Investigational Approval

Theravance Biopharma Submits IBD Drug for FDA Investigational Approval

Theravance Biopharma, Inc., a company focused on underserved markets related to infectious diseases, lung and gastrointestinal tract disorders, recently announced in a press release the submission of an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) for its investigational product TD-1473, a potential therapy for inflammatory intestinal conditions.

TD-1473 is a new oral, potent inhibitor of the pan-Janus kinase (JAK) of the gastrointestinal (GI) tract. The compound was found to have a high affinity for each of the enzymes in the JAK family, namely JAK1, JAK2, JAK3, and TYK2. These enzymes play an important role in signal transmission on the JAK/STAT pathway, which is known to modulate and control the activity of a broad range of pro-inflammatory cytokines. The blockade of these enzymes with TD-1473 can reduce the triggers for an inflammatory state.

Ulcerative colitis is a type of inflammatory bowel disorder (IBD) characterized by inflammation of the colon. Previous studies have shown that TD-1473 offers clinical benefit as a therapy for ulcerative colitis.

An important feature of Theravance Biopharma’s TD-1473 is that it is GI-targeted, having been specifically designed to distribute exclusively to the GI tract tissues, while minimizing systemic exposure to the compound.

If the FDA accepts the application for TD-1473, Theravance Biopharma plans to start a Phase 1 trial in healthy individuals to assess the tolerability, safety and pharmacokinetics of both single and multiple ascending doses of the drug. This Phase 1 study is expected to start early 2016.

“TD-1473 is a GI-targeted pan-JAK inhibitor designed to maximize the therapeutic potential of JAK inhibition, while minimizing the safety and tolerability concerns associated with systemic JAK blockade. We believe that this product profile has the potential to offer important benefits in a range of inflammatory intestinal disease including ulcerative colitis,” said the Senior Vice President, Research and Development of Theravance Biopharma, Dr. Mathai Mammen, in the press release. “Patients with ulcerative colitis need a therapy with greater efficacy and safety than those treatments that are available to them today. With this important patient need in mind, we look forward to initiating the Phase 1 study in the near future.”

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