Theravance Biopharma Submits Investigational New Drug Application to the FDA

Theravance Biopharma, Inc. (NASDAQ: TBPH) has submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration. The IND application is to conduct the first-in-human study of TD-1473, an orally administered GI-targeted pan-Janus kinase (JAK) inhibitor.
According to the press release:

The Company is developing TD-1473 as an investigational compound with the potential to treat a range of inflammatory intestinal disorders. Pending FDA’s acceptance of the filing, Theravance Biopharma will initiate a Phase 1 study investigating the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of the compound in healthy subjects. The Company expects to initiate the Phase 1 trial by early 2016.
TD-1473 is an internally-discovered JAK inhibitor that has demonstrated a high affinity for each of the JAK family of enzymes (JAK1, JAK2, JAK3 and TYK2). Through the inhibition of these enzymes, TD-1473 interferes with the JAK/STAT signaling pathway and, in turn, modulates the activity of a wide range of pro-inflammatory cytokines. This mechanism has previously demonstrated therapeutic benefit in the treatment of ulcerative colitis. Importantly, TD-1473 is a GI-targeted treatment specifically designed to distribute adequately and exclusively to the tissues of the GI tract and minimize systemic exposure.
“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 Mathai Mammen, M.D., Ph.D., Senior Vice President, Research and Development of Theravance Biopharma. “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.”

Click here to read the full press release.