The Janssen Pharmaceutical Companies of Johnson & Johnson announced today their entry into a worldwide collaboration with an affiliate of Theravance Biopharma, Inc. to develop TD-1473, a first-in-class oral, gastrointestinal (GI) restricted pan-Janus kinase (JAK) inhibitor for the treatment of inflammatory bowel disease (IBD), which includes Crohn’s disease and ulcerative colitis (UC).
Under the terms of the agreement, Theravance Biopharma will complete a Phase 2 study in Crohn’s disease and a Phase 2b/3 induction and maintenance study in UC, planned to start in 2018. Following availability of Phase 2 data from both studies, Janssen Biotech, Inc. (Janssen) may elect to enter into an exclusive license arrangement for the program and would then assume a lead role in the subsequent development of TD-1473 in Crohn’s disease. Theravance Biopharma will continue to conduct TD-1473 development in UC through the conclusion of the Phase 2b/3 program.
If TD-1473 is commercialized, Theravance Biopharma has the option to co-commercialize in the U.S., and Janssen would have sole commercialization responsibilities outside the U.S. As part of the agreement, Theravance Biopharma will receive an upfront payment and will be eligible to receive additional amounts if Janssen elects to remain in the collaboration following the completion of the Phase 2 activities.
IBD affects five million people worldwide and the incidence is growing., A great unmet need remains as many patients who receive treatment today do not achieve remission and up to 80 percent of patients with Crohn’s disease and 30 percent of patients with UC eventually progress to surgery.
“Adding TD-1473 to the Janssen Immunology portfolio reinforces our commitment to transforming patient outcomes with the potential to offer a first-in-class oral, local acting pan-JAK inhibitor with broad use across GI-related inflammatory disease,” said Scott E. Plevy, M.D., Vice President, Disease Area Leader, Inflammatory Bowel Disease, Janssen Research & Development, LLC. “We look forward to advancing this promising, oral, drug candidate through clinical development as we continue to address the significant unmet needs of people living with Crohn’s disease and UC around the world.”
TD-1473, a potential first-in-class oral, local acting GI restricted pan-JAK inhibitor for IBD, is specifically designed to act directly at the inflammation site in the intestinal wall to subsequently limit systemic exposure. The compound has previously been tested in a Phase 1a study and completed an initial cohort in Phase 1b, which support advancing TD-1473 into a Phase 2 study in Crohn’s disease and a Phase 2b/3 study in UC in 2018.