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 dose
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