Theravance Biopharma has dosed the first patient in a Phase II clinical trial assessing the efficacy, safety and tolerability of TD-1473 to treat patients with Crohn’s disease.
The multi-centre, double-blind trial is expected to enrol 160 patients with moderately to severely active Crohn’s disease.
Patients will be randomised to one of two active doses of TD-1473 or placebo once daily for up to 12 weeks.
Primary objective of the placebo-controlled, parallel-group trial is improvement in Crohn's Disease Activity Index (CDAI) score determined at 12 weeks.
An active treatment extension phase is also included in the trial for patients completing the 12-week induction phase.
Theravance Biopharma chief medical officer Brett Haumann said: “Clinical data generated to date provide us with confidence as we begin a comprehensive late-stage development programme for TD-1473, encompassing this study in Crohn's disease and an upcoming Phase IIb/III trial in patients with ulcerative colitis.
“We are hopeful that findings from these trials will demonstrate desired therapeutic results in these indications with an acceptable safety profile, and further confirm the localisation of biological activity within the intestine with minimal systemic exposure.”
Theravance has developed TD-1473 as part of a co-development and commercialisation agreement with Janssen Biotech.
The deal also covers related back-up compounds for inflammatory intestinal diseases such as ulcerative colitis and Crohn’s disease.
TD-1473 is an investigational, orally-administered and gut-selective pan-Janus kinase (JAK) inhibitor that has the potential to be used as a treatment for multiple inflammatory intestinal diseases.
Unlike other oral investigational JAK inhibitors, TD-1473 has the ability to act locally at the site of inflammation in the intestinal wall with least systemic exposure.