Compound Designed for Targeted Activity in Gastrointestinal (GI) Tract Tissues to Optimize Efficacy and Safety Profile in Range of Inflammatory Intestinal Diseases
DUBLIN, Ireland I November 2, 2015 I Theravance Biopharma, Inc. (NASDAQ: TBPH) (“Theravance Biopharma” or the “Company”) today announced that it has submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) to conduct the first-in-human study of TD-1473, a novel, potent, and orally administered GI-targeted pan-Janus kinase (JAK) inhibitor. 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.”
About Theravance Biopharma
The mission of Theravance Biopharma (NASDAQ: TBPH) is to create value from a unique and diverse set of assets: an approved product; a development pipeline of late-stage assets; and a productive research platform designed for long-term growth.
Our pipeline of internally discovered product candidates includes potential best-in-class opportunities in underserved markets in the acute care setting, representing multiple opportunities for value creation. VIBATIV® (telavancin), our first commercial product, is a once-daily dual-mechanism antibiotic approved in the U.S., Europe and certain other countries for certain difficult-to-treat infections. Revefenacin (TD-4208) is an investigational long-acting muscarinic antagonist (LAMA) being developed as a potential once-daily, nebulized treatment for COPD. Axelopran (TD-1211) is an investigational potential once-daily, oral treatment for opioid-induced constipation (OIC). Our earlier-stage clinical assets represent novel approaches for potentially treating diseases of the lung and gastrointestinal tract and infectious disease. In addition, we have an economic interest in future payments that may be made by GlaxoSmithKline plc pursuant to its agreements with Theravance, Inc. relating to certain drug development programs, including the combination of fluticasone furoate, umeclidinium and vilanterol (or “Closed Triple”).
With our successful drug discovery and development track record, commercial infrastructure, experienced management team and efficient corporate structure, we believe that we are well positioned to create value for our shareholders and make a difference in the lives of patients.
SOURCE: Theravance
Post Views: 115
Compound Designed for Targeted Activity in Gastrointestinal (GI) Tract Tissues to Optimize Efficacy and Safety Profile in Range of Inflammatory Intestinal Diseases
DUBLIN, Ireland I November 2, 2015 I Theravance Biopharma, Inc. (NASDAQ: TBPH) (“Theravance Biopharma” or the “Company”) today announced that it has submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) to conduct the first-in-human study of TD-1473, a novel, potent, and orally administered GI-targeted pan-Janus kinase (JAK) inhibitor. 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.”
About Theravance Biopharma
The mission of Theravance Biopharma (NASDAQ: TBPH) is to create value from a unique and diverse set of assets: an approved product; a development pipeline of late-stage assets; and a productive research platform designed for long-term growth.
Our pipeline of internally discovered product candidates includes potential best-in-class opportunities in underserved markets in the acute care setting, representing multiple opportunities for value creation. VIBATIV® (telavancin), our first commercial product, is a once-daily dual-mechanism antibiotic approved in the U.S., Europe and certain other countries for certain difficult-to-treat infections. Revefenacin (TD-4208) is an investigational long-acting muscarinic antagonist (LAMA) being developed as a potential once-daily, nebulized treatment for COPD. Axelopran (TD-1211) is an investigational potential once-daily, oral treatment for opioid-induced constipation (OIC). Our earlier-stage clinical assets represent novel approaches for potentially treating diseases of the lung and gastrointestinal tract and infectious disease. In addition, we have an economic interest in future payments that may be made by GlaxoSmithKline plc pursuant to its agreements with Theravance, Inc. relating to certain drug development programs, including the combination of fluticasone furoate, umeclidinium and vilanterol (or “Closed Triple”).
With our successful drug discovery and development track record, commercial infrastructure, experienced management team and efficient corporate structure, we believe that we are well positioned to create value for our shareholders and make a difference in the lives of patients.
SOURCE: Theravance
Post Views: 115
