Janssen enters into global collaboration with Theravance Biopharma

Zealand Pharma & UniQuest to develop candidates for gastrointestinal diseases
Credit: Shutterstock.com/ Sebastian Kaulitzki

The Janssen Pharmaceutical Companies of Johnson & Johnson have entered into a worldwide collaboration with an affiliate of Theravance Biopharma to develop an oral, Pan-Jak inhibitor drug candidate for the treatment of inflammatory bowel disease

TD-1473 is a first-in-class oral, gastrointestinal 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 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 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 commercialised, Theravance Biopharma has the option to co-commercialize in the U.S., and Janssen would have sole commercialization responsibilities outside the US.

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% of patients with Crohn’s disease and 30% of patients with UC eventually progress to surgery.

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.