The Janssen Pharmaceutical Companies of Johnson & Johnson announce their worldwide collaboration with 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).
Theravance Biopharma will be conducting Phase II/III studies this year as part of the agreement for both Crohn’s and ulcerative colitis. Following the conduciveness of those studies data, Janssen will have the choice of entering into an exclusive license arrangement and assuming lead role for the Crohn’s program of TD-1473. While this is being evaluated, Theravance will continue development of TD-1473 in ulcerative colitis.
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. 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 II activities.
“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,” says 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.”
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.
TD-1473 is a potential first-in-class oral, local acting GI restricted pan-JAK inhibitor for IBD. It 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 Ia study and completed an initial cohort in Phase Ib, which support advancing TD-1473 into a Phase II study in Crohn’s disease and a Phase IIb/III study in UC in 2018.